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1.  Ontological security and connectivity provided by pets: a study in the self-management of the everyday lives of people diagnosed with a long-term mental health condition 
BMC Psychiatry  2016;16:409.
Despite evidence that connecting people to relevant wellbeing-related resources brings therapeutic benefit, there is limited understanding, in the context of mental health recovery, of the potential value and contribution of pet ownership to personal support networks for self-management. This study aimed to explore the role of pets in the support and management activities in the personal networks of people with long-term mental health problems.
Semi-structured interviews centred on ‘ego’ network mapping were conducted in two locations (in the North West and in the South of England) with 54 participants with a diagnosis of a long-term mental health problem. Interviews explored the day-to-day experience of living with a mental illness, informed by the notion of illness work undertaken by social network members within personal networks. Narratives were elicited that explored the relationship, value, utility and meaning of pets in the context of the provision of social support and management provided by other network members. Interviews were recorded, then transcribed verbatim before being analysed using a framework analysis.
The majority of pets were placed in the central, most valued circle of support within the network diagrams. Pets were implicated in relational work through the provision of secure and intimate relationships not available elsewhere. Pets constituted a valuable source of illness work in managing feelings through distraction from symptoms and upsetting experiences, and provided a form of encouragement for activity. Pets were of enhanced salience where relationships with other network members were limited or difficult. Despite these benefits, pets were unanimously neither considered nor incorporated into individual mental health care plans.
Drawing on a conceptual framework built on Corbin and Strauss’s notion of illness ‘work’ and notions of a personal workforce of support undertaken within whole networks of individuals, this study contributes to our understanding of the role of pets in the daily management of long-term mental health problems. Pets should be considered a main rather than a marginal source of support in the management of long-term mental health problems, and this has implications for the planning and delivery of mental health services.
PMCID: PMC5146817  PMID: 27931210
Mental health; Social network mapping; Pets; Qualitative research; United Kingdom
2.  Psychiatrists’ experiences of suicide assessment 
BMC Psychiatry  2016;16:440.
Clinical guidelines for suicide prevention often stress the identification of risk and protective factors as well as the evaluation of suicidal intent. However, we know very little about what psychiatrists actually do when they make these assessments. The aim was to investigate psychiatrists’ own accounts of suicide assessment consultations, with a focus on their behaviors, attitudes and emotions.
Semi-structured in depth interviews were carried out with a purposive selection of 15 psychiatrists.
Thematic analysis revealed three main themes: understanding the patient in a precarious situation, understanding one’s own reactions, and understanding how the doctor-patient relationship impacted on risk assessment and management decisions. Emotional contact and credibility issues were common subthemes that arose when the respondents talked about trying to understand the patient. The psychiatrists stressed the semi-intuitive nature of their assessments. Problems related to the use of risk factor assessments and rating scales were apparent. Assessment consultations could evoke physical and emotional symptoms of anxiety, and concerns about responsibility could lead to repressive management decisions. In situations of mutual trust, however, the assessment consultation could kick-start a therapeutic process.
This study highlights psychiatrists’ experiences in clinical suicide assessment situations. Findings have implications for professional development as well as for service delivery.
PMCID: PMC5148860  PMID: 27938368
Suicide assessment; Psychiatrists’ experiences; Involuntary care; Medical training; Professional development
3.  Attentional bias modification in depression through gaze contingencies and regulatory control using a new eye-tracking intervention paradigm: study protocol for a placebo-controlled trial 
BMC Psychiatry  2016;16:439.
Attentional biases, namely difficulties both to disengage attention from negative information and to maintain it on positive information, play an important role in the onset and maintenance of the disorder. Recently, researchers have developed specific attentional bias modification (ABM) techniques aimed to modify these maladaptive attentional patterns. However, the application of current ABM procedures has yielded, so far, scarce results in depression due, in part, to some methodological shortcomings.
The aim of our protocol is the application of a new ABM technique, based on eye-tracker technology, designed to objectively train the specific attentional components involved in depression and, eventually, to reduce depressive symptoms.
Based on sample size calculations, 32 dysphoric (BDI ≥13) participants will be allocated to either an active attentional bias training group or a yoked-control group. Attentional training will be individually administered on two sessions in two consecutive days at the lab. In the training task series of pairs of faces (i.e. neutral vs. sad; neutral vs. happy; happy vs. sad) will be displayed. Participants in the training group will be asked to localize as quickly as possible the most positive face of the pair (e.g., the neutral face in neutral vs. sad trials) and maintain their gaze on it for 750 ms or 1500 ms, in two different blocks, to advance to the next trial. Participants’ maintenance of gaze will be measured by an eye-tracking apparatus. Participants in the yoked-control group will be exposed to the same stimuli and the same average amount of time than the experimental participants but without any instruction to maintain their gaze or any feedback on their performance. Pre and post training measures will be obtained to assess cognitive and emotional changes after the training.
The findings from this research will provide a proof-of-principle of the efficacy of eye-tracking paradigms to modify attentional biases and, consequently, to improve depressed mood. If the findings are positive, this new training approach may result in the improvement of cognitive bias modification procedures in depression.
Trial registration
This trial was retrospectively registered on July 28, 2016 with the NCT02847793 registration number and the title ‘Attentional Bias Modification Through Eye-tracker Methodology (ABMET)’.
Electronic supplementary material
The online version of this article (doi:10.1186/s12888-016-1150-9) contains supplementary material, which is available to authorized users.
PMCID: PMC5146883  PMID: 27931196
Depression; Cognitive processes; Attentional biases; Attentional bias modification; Eye-tracking; Cognitive bias modification; Dysphoria
4.  Probable clozapine-induced parenchymal lung disease and perimyocarditis: a case report 
BMC Psychiatry  2016;16:438.
Clozapine is the archetypical atypical antipsychotic, its primary indication being treatment resistant schizophrenia. Severe side effects caused by clozapine, including leukopenia, agranulocytosis, and myocarditis, are well known. A rarely described side effect is concurrent perimyocarditis and parenchymal lung disease.
Case presentation
A previously physically healthy 23-year-old male Caucasian that suffered from schizophrenia presented with flu-like symptoms 1 week after starting clozapine treatment. Treatment with clozapine was discontinued. He developed respiratory distress. Investigations showed significant parenchymal infiltration in both of the lungs, pericardial fluid, and heart failure. He initially received treatment for suspected malignant neuroleptic syndrome and later for suspected infection, but these tentative diagnoses were not confirmed. The patient’s condition gradually improved. In retrospect, clozapine-induced parenchymal lung disease and perimyocarditis were deemed the most probable causes.
Concurrent perimyocarditis and parenchymal lung disease are rare side effects of clozapine. Clozapine-induced disease in general is considered an exclusion diagnosis. Lacking a verifiable diagnosis when suspecting a side effect of clozapine, clinicians might treat the most likely and serious condition presenting and consider discontinuing clozapine until the diagnostic uncertainty is reasonably resolved.
PMCID: PMC5146900  PMID: 27931201
Clozapine; Case report; Side effects; Pericarditis; Perimyocarditis; Diffuse parenchymal lung disease; Schizophrenia
5.  Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study 
BMC Psychiatry  2016;16:434.
Many of the posttraumatic stress disorder (PTSD) treatment guidelines recognize the use of selective serotonin reuptake inhibitors as first-line pharmacological treatment. In Japan, there were no published studies investigating the effectiveness and safety of sertraline for PTSD in a clinical setting.
We conducted a retrospective medical chart review of the dosage, effectiveness, and safety of sertraline for the PTSD treatment in Japan. Data were collected from medical charts of patients of PTSD, caused by various types of trauma, who were treated with sertraline between July 2006 and October 2012 during their regular clinical practice. To evaluate the effectiveness, the investigators retrospectively assessed the severity and improvement of the symptoms using the Clinical Global Impressions − Severity and the Clinical Global Impressions − Improvement.
The study population was 122 Japanese patients aged ≥18 years with a diagnosis of PTSD who were treated with sertraline (median duration, 10.6 months). Doses ranged from 12.5 to 150 mg/day, mostly 25 and 50 mg/day. The median duration of observation was 10.8 months. Out of those, 50% of patients were regarded as responders by using the Clinical Global Impressions - Improvement at the end of sertraline treatment or the last observation. Two-thirds (65.6%) of patients improved in the severity of PTSD, as assessed by Clinical Global Impressions - Severity, whereas 32.8% showed no change, and 1.6% worsened. Subgroups analyses and logistic regression analyses suggested that the type of traumatic events was the factor with the highest influence on the response rate. The adverse events in this chart review were consistent with the known safety profile of sertraline. There were no reports of serious or severe adverse events considered to be related to sertraline.
Our study suggested the effectiveness of sertraline for the treatment of PTSD in a Japanese clinical setting, and the obtained safety profile was consistent with the generally known safety profile of sertraline.
Trial registration (Identification No. NCT01607593). Registered May 21, 2012.
PMCID: PMC5142275  PMID: 27923359
Posttraumatic stress disorder (PTSD); Sertraline; Selective serotonin reuptake inhibitors (SSRI); Antidepressant; Pharmacotherapy; Chart review; Japan
6.  A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis 
BMC Psychiatry  2016;16:435.
To examine the effectiveness and acceptability of an 8-week individual tailored cognitive behavioural therapy (CBT) intervention for the treatment of depressive symptoms in those newly diagnosed with multiple sclerosis.
The current study presents a pilot, parallel group randomized controlled trial (RCT) with an allocation ratio of 1:1 conducted in a large research and teaching hospital in Melbourne, Australia. 30 individuals with a mean age of 36.93 years (SD = 9.63) who were newly diagnosed with multiple sclerosis (MS) (X = 24.87 months, SD = 15.61) were randomized to the CBT intervention (n = 15) or treatment as usual (TAU) (n = 15). The primary outcome was level of depressive symptoms using the Beck Depression Inventory-II (BDI-II). Secondary outcomes were level of anxiety, fatigue and pain impact, sleep quality, coping, acceptance of MS illness, MS related quality of life, social support, and resilience. Tertiary outcomes were acceptability and adherence to the intervention.
Large between group treatment effects were found for level of depressive symptoms at post and at 20 weeks follow-up (d = 1.66–1.34). There were also small to large group treatment effects for level of anxiety, fatigue and pain impact, sleep quality, MS related quality of life, resilience, and social support at post and at 20 weeks follow-up (d = 0.17–1.63). There were no drop-outs and participants completed all treatment modules. All participants reported the treatment as ‘very useful’, and most (73.4%) reported that the intervention had addressed their problems ‘completely’.
These data suggest that the tailored early intervention is appropriate and clinically effective for the treatment of depressive symptoms in those newly diagnosed with MS. A larger RCT comparing the CBT intervention with an active comparative treatment with longer term follow-up and cost effectiveness analyses is warranted. The pilot trial has been retrospectively registered on 28/04/2016 with the ISRCTN registry (trial ID ISRCTN10423371).
PMCID: PMC5142334  PMID: 27927175
Depression; Cognitive behavioral therapy (CBT); Multiple sclerosis; Newly diagnosed; Early intervention; Anxiety
7.  Reliability, validity and factorial structure of the Arabic version of the international suicide prevention trial (InterSePT) scale for suicidal thinking in schizophrenia patients in Doha, Qatar 
BMC Psychiatry  2016;16:437.
Patients with schizophrenia are known to have higher rates of mortality and morbidity when compared to the general population. Suicidality is a major contributor to increased mortality. The International Suicide Prevention Trial (InterSePT) Scale for Suicidal Thinking (ISST) is a validated tool to assess current suicidal ideation in patients with schizophrenia. The aims of the study were to culturally adapt the Arabic translation of ISST and to examine the psychometric characteristics of the Arabic version of the ISST among patients with schizophrenia in Qatar.
ISST was translated and adapted into formal Arabic using the back translation method. Patients diagnosed with schizophrenia were randomly recruited from the department of Psychiatry, Rumailah Hospital, Doha, Qatar. Healthy controls were randomly recruited from two primary health care centers in Doha, Qatar. The Arabic version of Module B for suicidality in Mini International Neuropsychiatric Interview was used as the gold standard to which the Arabic ISST was compared.
The study sample (n = 199) was composed of 100 patients diagnosed with schizophrenia (age 35.30 ± 10.04 years; M/F is 2/1) and 99 controls (age 33.98 ± 8.33 years; M/F is 2/3). The mean score on the ISST was 3.03 ± 4.75 vs. 0.47 ± 1.44 for the schizophrenia and control groups, respectively. Inter-rater reliability coefficient was 0.95, p > 0.001. The overall Cronbach’s alpha was 0.92. Principal Component Analysis produced 3 factors explaining a total of 73.8% of variance.
This is the first study in the Arab countries to validate the Arabic version of the ISST. The psychometric properties indicate that the Arabic ISST is a valid tool to assess the severity of suicidal ideation in Arabic patients with schizophrenia.
PMCID: PMC5142345  PMID: 27927173
Suicidality; Suicide scales; Schizophrenia; Arabs
8.  A controlled trial of implementing a complex mental health intervention for carers of vulnerable young people living in out-of-home care: the ripple project 
BMC Psychiatry  2016;16:436.
Out-of-home care (OoHC) refers to young people removed from their families by the state because of abuse, neglect or other adversities. Many of the young people experience poor mental health and social function before, during and after leaving care. Rigorously evaluated interventions are urgently required.
This publication describes the protocol for the Ripple project and notes early findings from a controlled trial demonstrating the feasibility of the work. The Ripple project is implementing and evaluating a complex mental health intervention that aims to strengthen the therapeutic capacities of carers and case managers of young people (12-17 years) in OoHC.
The study is conducted in partnership with mental health, substance abuse and social services in Melbourne, with young people as participants. It has three parts:
1. Needs assessment and implementation of a complex mental health intervention; 2. A 3-year controlled trial of the mental health, social and economic outcomes; and 3. Nested process evaluation of the intervention.
Early findings characterising the young people, their carers and case managers and implementing the intervention are available. The trial Wave 1 includes interviews with 176 young people, 52% of those eligible in the study population, 104 carers and 79 case managers.
Implementing and researching an affordable service system intervention appears feasible and likely to be applicable in other places and countries. Success of the intervention will potentially contribute to reducing mental ill-health among these young people, including suicide attempts, self-harm and substance abuse, as well as reducing homelessness, social isolation and contact with the criminal justice system.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12615000501549. Retrospectively registered 19 May 2015.
PMCID: PMC5142401  PMID: 27927174
Out-of-home care; Youth mental health; Prevention; Implementation; Complex intervention; Looked after children
9.  Blended CBT versus face-to-face CBT: a randomised non-inferiority trial 
BMC Psychiatry  2016;16:432.
Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face CBT for adult major depressive disorder.
The study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of ftf CBT is alternated with six to eight online modules (NoDep). TAU is defined as 12 sessions of ftf CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Additionally, the study will include an economic evaluation. All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by regressing the three-month follow-up PHQ-9 data on the baseline PHQ-9 score and a treatment group indicator using ancova. A sample size of 130 in two balanced groups will yield a power of at least 80% to detect standardised mean differences above 0.5 on a normally distributed variable.
This study design will compare B-CBT and ftf CBT in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted.
Trial registration NCT02796573. Registered June 1st 2016. Currently recruiting participants.
PMCID: PMC5139089  PMID: 27919234
10.  The cross-interaction between global and age-comparative self-rated health on depressive symptoms–considering both the individual and combined effects 
BMC Psychiatry  2016;16:433.
Numerous studies suggesting the relation between self-rated health (SRH) and depression have been reported using different measures. Therefore, we attempted to determine the difference in a depressive scale based on the different ways of measuring health between global SRH (SRH-global) and age-comparative SRH (SRH-age). Then, the combined effect of SRH-global and SRH-age on depressive symptoms was further investigated.
Data from the Korean Longitudinal Study of Ageing (KLoSA) from 2008 to 2012 were analyzed. We divided the SRH-global and SRH-age into three levels—high, middle, and low—and combined each into nine new categories (SRH-combi). The Center for Epidemiologic Studies Depression Scale-10 Korean edition was used as the dependent variable.
A total of 8621 participant were enrolled at baseline. Individuals with lower SRHs-age compared to SRH-global tended to be more vulnerable to depressive symptoms. Low SRH-global with low (b = 0.654, p < 0.001) and middle SRH-age (b = 0.210, p = 0.003) showed association with higher CESD scores. Participants with high SRH-global × low SRH-age also had higher scores (b = 0.536, p < 0.001) compared to the “middle SRH-global × middle SRH-age” reference group. In contrast, among the middle (b = −0.696, p < 0.001) and high SRH-global (b = −0.545, p < 0.001) groups, participants with superior SRH-age had statistically lower CESD scores than the reference group.
Although a sole general SRH has historically been widely used, it has been suggested that use of both general and age-comparative SRH would be more powerful and easy when we consider analyzing depression in old age.
Electronic supplementary material
The online version of this article (doi:10.1186/s12888-016-1098-9) contains supplementary material, which is available to authorized users.
PMCID: PMC5139095  PMID: 27919247
Self-rated health; Combined; Age comparative; Depression; Old aged
11.  Homesick: residential and care patterns in patients with severe mental illness 
BMC Psychiatry  2016;16:431.
Changes in the residential and care settings of patients with severe mental illness (SMI) are a concern because of the large variety of possible negative consequences. This study describes patterns of changes in the residential and care settings of SMI patients and explores associations between these changes, sociodemographics, and clinical characteristics.
From January 2006 to January 2012, all data relating to changes in residential and/or care setting by SMI patients (N = 262) were collected from electronic case files. Data covering psychopathology, substance use, and medication adherence were assessed in 2006.
There were more changes in the residential than in the care setting. In 6 years, only 22% of our sample did not move, 23% changed residence once, 19% twice, 10% three times, and 26% four or more times. Substance use predicted changes of care and/or residential setting and rehospitalisation. The severity of negative symptoms predicted rehospitalisation and duration of hospitalisation. Disorganisation symptoms predicted the duration of hospitalisation.
A majority of patients with SMI changed residential and/or care settings several times in 6 years. Patients with substance use or severe negative and disorganisation symptoms may need more intensive and customised treatment. Further research is needed to investigate prevention programmes for highly-frequent movers.
PMCID: PMC5135762  PMID: 27912730
Changes of residential setting; Changes of care setting; Changes in severe mental illness; Address changes; Hospitalisation; Revolving door
12.  Smoking in pregnancy, adolescent mental health and cognitive performance in young adult offspring: results from a matched sample within a Finnish cohort 
BMC Psychiatry  2016;16:430.
The association between prenatal exposure to maternal cigarette smoking (PEMCS) and adult cognition is debated, including if there are differences according to sex. We aimed to determine if there are associations between PEMCS and cognition in early adulthood in men and women and examine if observed associations were mediated by adolescent mental health factors that are associated with cognition, namely psychotic-like experiences (PLEs), inattention and hyperactivity, and other externalizing behaviors.
Participants were 471 individuals drawn from the general population-based Northern Finland 1986 Birth Cohort (NFBC 1986) followed up from pregnancy and birth to early adulthood; individuals with PEMCS were matched with those without PEMCS by socioeconomic and demographic factors. Cognitive performance in adulthood was assessed with a range of tests and their association with PEMCS was measured by sex using hierarchical linear regression, unadjusted and then controlling for potential confounders, mediators and moderators, including adolescent mental health factors.
There were no associations between PEMCS and cognitive scores in females. In males, there were associations with vocabulary (beta = -0.444, 95% CI: -0.783, -0.104) and matrix reasoning (beta = -0.379, 95% CI: -0.711, -0.047).
While associations between PEMCS and cognition were limited, observed findings with measures of general intelligence in males contribute to suggestions of differences in response to PEMCS by sex. Furthermore, observed associations may be partly mediated by earlier inattention and hyperactivity. Findings add support to efforts aimed to eliminate smoking in pregnancy.
PMCID: PMC5133752  PMID: 27908296
Prenatal smoking; Cognition; Psychotic-like experiences; Inattention and hyperactivity
13.  Development of a measure of model fidelity for mental health Crisis Resolution Teams 
BMC Psychiatry  2016;16:427.
Crisis Resolution Teams (CRTs) provide short-term intensive home treatment to people experiencing mental health crisis. Trial evidence suggests CRTs can be effective at reducing hospital admissions and increasing satisfaction with acute care. When scaled up to national level however, CRT implementation and outcomes have been variable. We aimed to develop and test a fidelity scale to assess adherence to a model of best practice for CRTs, based on best available evidence.
A concept mapping process was used to develop a CRT fidelity scale. Participants (n = 68) from a range of stakeholder groups prioritised and grouped statements (n = 72) about important components of the CRT model, generated from a literature review, national survey and qualitative interviews. These data were analysed using Ariadne software and the resultant cluster solution informed item selection for a CRT fidelity scale. Operational criteria and scoring anchor points were developed for each item. The CORE CRT fidelity scale was then piloted in 75 CRTs in the UK to assess the range of scores achieved and feasibility for use in a 1-day fidelity review process. Trained reviewers (n = 16) rated CRT service fidelity in a vignette exercise to test the scale’s inter-rater reliability.
There were high levels of agreement within and between stakeholder groups regarding the most important components of the CRT model. A 39-item measure of CRT model fidelity was developed. Piloting indicated that the scale was feasible for use to assess CRT model fidelity and had good face validity. The wide range of item scores and total scores across CRT services in the pilot demonstrate the measure can distinguish lower and higher fidelity services. Moderately good inter-rater reliability was found, with an estimated correlation between individual ratings of 0.65 (95% CI: 0.54 to 0.76).
The CORE CRT Fidelity Scale has been developed through a rigorous and systematic process. Promising initial testing indicates its value in assessing adherence to a model of CRT best practice and to support service improvement monitoring and planning. Further research is required to establish its psychometric properties and international applicability.
Electronic supplementary material
The online version of this article (doi:10.1186/s12888-016-1139-4) contains supplementary material, which is available to authorized users.
PMCID: PMC5133753  PMID: 27905909
Crisis Resolution Team; Mental health services; Acute care; Fidelity; Implementation
14.  Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence 
BMC Psychiatry  2016;16:428.
The treatment of methamphetamine dependence is a continuing global health problem. Agonist type pharmacotherapies have been used successfully to treat opioid and nicotine dependence and are being studied for the treatment of methamphetamine dependence. One potential candidate is lisdexamfetamine, a pro-drug for dexamphetamine, which has a longer lasting therapeutic action with a lowered abuse potential. The purpose of this study is to determine the safety of lisdexamfetamine in this population at doses higher than those currently approved for attention deficit hyperactivity disorder or binge eating disorder.
This is a phase 2 dose escalation study of lisdexamfetamine for the treatment of methamphetamine dependence. Twenty individuals seeking treatment for methamphetamine dependence will be recruited at two Australian drug and alcohol services. All participants will undergo a single-blinded ascending-descending dose regime of 100 to 250 mg lisdexamfetamine, dispensed daily on site, over an 8-week period. Participants will be offered counselling as standard care. For the primary objectives the outcome variables will be adverse events monitoring, drug tolerability and regimen completion. Secondary outcomes will be changes in methamphetamine use, craving, withdrawal, severity of dependence, risk behaviour and other substance use. Medication acceptability, potential for non-prescription use, adherence and changes in neurocognition will also be measured.
Determining the safety of lisdexamfetamine will enable further research to develop pharmacotherapies for the treatment of methamphetamine dependence.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12615000391572 Registered 28th April 2015.
PMCID: PMC5134059  PMID: 27905916
Methamphetamine; Study protocol; Lisdexamfetamine; Pharmacotherapy; Dose-finding; Stimulant use disorder
16.  Treatment-emergent depression and anxiety between peginterferon alpha-2a versus alpha-2b plus ribavirin for chronic hepatitis C 
BMC Psychiatry  2016;16:424.
This study investigates differences in depression and anxiety between patients with chronic hepatitis C who are treated with peginterferon alpha-2a (PegIFN-α-2a) plus ribavirin and those who are treated with peginterferon alpha-2b (PegIFN-α-2b) plus ribavirin.
In this 24 week, non-randomized, observational, prospective study, 55 patients with chronic hepatitis C were treated with PegIFN-α-2a plus ribavirin (Group 1), and 26 patients were treated with PegIFN-α-2b plus ribavirin (Group 2). All patients underwent assessment using the Hospital Anxiety and Depression Scale (HADS) at the baseline and at weeks 4, 12 and 24. Patients with depression scores (HADS-D) ≥ 8 and anxiety scores (HADS-A) ≥ 8 were defined as having depression and anxiety, respectively. The factors that were associated with depression and anxiety during the 24 week antiviral treatment were determined.
During the 24 week antiviral treatment, the proportion of patients with depression significantly increased over time in both groups (Group 1: p = 0.048; Group 2: p = 0.044). The proportion of patients with anxiety did not significantly change during the follow-up period in either group. Incidences of depression or anxiety did not differ significantly between Group 1 and Group 2. A history of alcohol use disorder was an independent predictor of depression at week 12 (p < 0.001) and week 24 (p < 0.001), and a poor virological response to treatment was associated with depression at week 24 (p = 0.029). Patients who had more physical comorbidities were more likely to suffer from anxiety at week 12 (p = 0.038).
This study did not identify significant differences in depression or anxiety between in patients with chronic hepatitis C who underwent a 24 week antiviral treatment regimen with PegIFN-α-2a plus ribavirin and those who underwent a regiment with PegIFN-α-2b plus ribavirin. Future research with larger samples and a randomized, controlled design are required to verify the findings in this study.
Trial registration
This clinical study has been registered at (Trial registration: NCT02943330).
PMCID: PMC5123322  PMID: 27884134
Anxiety; Depression; Interferon; Ribavirin; Hepatitis C
17.  Technology-enhanced multi-domain at home continuum of care program with respect to usual care for people with cognitive impairment: the Ability-TelerehABILITation study protocol for a randomized controlled trial 
BMC Psychiatry  2016;16:425.
According to the World Alzheimer Report (Prince, The Global Impact of Dementia: an Analysis of Prevalence, Incidence, Cost and Trends, 2015), 46.8 million people worldwide are nowadays living with dementia. And this number is estimated to approximate 131.5 million by 2050, with an increasing burden on society and families. The lack of medical treatments able to stop or slow down the course of the disease has moved the focus of interest toward the nonpharmacological approach and psychosocial therapies for people with/at risk of dementia, as in the Mild Cognitive Impairment (MCI) condition. The purpose of the present study is to test an individualized home-based multidimensional program aimed at enhancing the continuum of care for MCI and outpatients with dementia in early stage using technology.
The proposed study is a single blind randomized controlled trial (RCT) involving 30 subjects with MCI and Alzheimer’s disease (AD) randomly assigned to the intervention group (Ability group), who will receive the “Ability Program”, or to the active control group (ACG), who will receive “Treatment As Usual” (TAU). The protocol provides for three steps of assessment: at the baseline (T_0), after treatment, (T_1) and at follow-up (T_2) with a multidimensional evaluation battery including cognitive functioning, behavioral, functional, and quality of life measures. The Ability Program lasts 6 weeks, comprises tablet-delivered cognitive (5 days/week) and physical activities (7 days/week) combined with a set of devices for the measurement and monitoring from remote of vital and physical health parameters. The TAU equally lasts 6 weeks and includes paper and pencil cognitive activities (5 days/week), with clinician’s prescription to perform physical exercise every day and to monitor selected vital parameters.
Results of this study will inform on the efficacy of a technology-enhanced home care service to preserve cognitive and motor levels of functioning in MCI and AD, in order to slow down their loss of autonomy in daily life. The expected outcome is to ensure the continuity of care from clinical practice to the patient’s home, enabling also cost effectiveness and the empowerment of patient and caregiver in the care process, positively impacting on their quality of life.
Trial registration ID: NCT02746484 (registration date: 12/apr/2016 – retrospectively registered).
PMCID: PMC5123349  PMID: 27887597
Telerehabilitation; Dementia; Mild cognitive impairment; Alzheimer’s disease; Continuum of care
18.  Experiences of support in working toward personal recovery goals: a collaborative, qualitative study 
BMC Psychiatry  2016;16:426.
Recovery can be understood as a subjective process guided by personal expectations, goals and hopes. The aim of the study was to explore how persons using a Community Mental Health Centre (CMHC) experienced that their expectations for treatment, and goals and hopes for recovery were supported by the health professionals during treatment.
Employing a hermeneutic–phenomenological approach, eight service users were interviewed about their expectations for treatment and their goals and hopes for recovery at the start of their contact with health professionals at a CMHC. Two years later, they were re-interviewed about their experiences of treatment and support from the health professionals in their work towards these goals and hopes. A collaborative approach was adopted. A co-researcher with lived experience took part in all stages of the study. Data were analysed by means of a data-driven stepwise approach in line with thematic analysis.
Five themes reflecting how participants experienced support from health professionals at the CMHC in their work towards their recovery goals were elicited, as follows: developing an understanding of oneself and one’s mental health problems; learning how to change feelings and behaviours; being ‘pushed’ into social arenas; finding helpful medication; and counselling in family, practical and financial issues. The participants’ expectations about counselling with regard to longer-term family, practical, and financial challenges were insufficiently met by the CMHC. In the experience of the service users, recovery occurred within the context of their everyday life with or without the support of their professional helpers.
To facilitate recovery, health professionals should acknowledge the service user’s personal goals and hopes and take a more comprehensive and longer-term approach to his or her needs and desires. Acknowledging and facilitating recovery goals by offering counselling with regard to family, practical and financial issues seems particularly important.
Electronic supplementary material
The online version of this article (doi:10.1186/s12888-016-1133-x) contains supplementary material, which is available to authorized users.
PMCID: PMC5124226  PMID: 27887587
Mental health; Recovery; Everyday life; Hope; Expectancy; Personal goal; Service user experience; Patient satisfaction; Patient-centred care; Psychotherapy; Mental health services
19.  Residence-related factors and psychological distress among evacuees after the Fukushima Daiichi nuclear power plant accident: a cross-sectional study 
BMC Psychiatry  2016;16:420.
Relocation following a disaster can impact the psychological well-being of evacuees. This study investigated the associations between residence-related factors and psychological distress among evacuees living in temporary housing after the Fukushima Daiichi Nuclear Power Plant accident.
Data from 525 participants living in temporary housing were collected. Associations between residence-related factors (frequent relocation, dissatisfaction with the residence, and plan to move to permanent housing) and psychological distress were measured. The psychological distress of evacuees was measured using the Japanese version of the 6-item Kessler scale (K6). We used a cut-off score of five to identify cases with psychological distress, the basis of Kessler’s 6 items for psychological distress.
Multivariate logistic regression analysis (n = 418) showed that frequent relocation (OR = 2.05, 95% CI: 1.14–3.66, p = 0.016) and dissatisfaction with the residence (OR = 2.48, 95% CI: 1.60–3.83, p < 0.001) was significantly associated with psychological distress. After stratifying by gender, dissatisfaction with the residence was associated with psychological distress, and a plan to move to permanent housing was significantly associated with psychological distress in women (OR = 1.93, 95% CI: 1.03–3.63, p = 0.041).
Frequent relocation and dissatisfaction with the residence were associated with psychological distress among evacuees following the Fukushima nuclear disaster. Evacuees should be provided with comfortable living spaces, and steps should be taken to reduce repeated relocation of evacuees. Thus, particular attention should be paid to women with a plan to move to permanent housing within this context.
PMCID: PMC5121974  PMID: 27881162
Psychological distress; Community mental health; Disaster; Relocation; Residence
20.  A pragmatic randomised multi-centre trial of multifamily and single family therapy for adolescent anorexia nervosa 
BMC Psychiatry  2016;16:422.
Considerable progress has been made in recent years in developing effective treatments for child and adolescent anorexia nervosa, with a general consensus in the field that eating disorders focussed family therapy (often referred to as Maudsley Family Therapy or Family Based Treatment) currently offers the most promising outcomes. Nevertheless, a significant number do not respond well and additional treatment developments are needed to improve outcomes. Multifamily therapy is a promising treatment that has attracted considerable interest and we report the results of the first randomised controlled trial of multifamily therapy for adolescent anorexia nervosa.
The study was a pragmatic multicentre randomised controlled superiority trial comparing two outpatient eating disorder focussed family interventions - multifamily therapy (MFT-AN) and single family therapy (FT-AN). A total of 169 adolescents with a DSM-IV diagnosis of anorexia nervosa or eating disorder not otherwise specified (restricting type) were randomised to the two treatments using computer generated blocks of random sizes to ensure balanced numbers in the trial arms. Independent assessors, blind to the allocation, completed evaluations at baseline, 3 months, 12 months (end of treatment) and 18 months.
Both treatment groups showed clinically significant improvements with just under 60% achieving a good or intermediate outcome (on the Morgan-Russell scales) at the end of treatment in the FT-AN group and more than 75% in the MFT-AN group - a statistically significant benefit in favour of the multifamily intervention (OR = 2.55 95%; CI 1.17, 5.52; p = 0.019). At follow-up (18 months post baseline) there was relatively little change compared to end of treatment although the difference in primary outcome between the treatments was no longer statistically significant. Clinically significant gains in weight were accompanied by improvements in mood and eating disorder psychopathology. Approximately half the patients in FT-AN and nearly 60% of those in MFT-AN had started menstruating.
This study confirms previous research findings demonstrating the effectiveness of eating disorder focused family therapy and highlights the additional benefits of bringing together groups of families that maximises the use of family resources and mutual support leading to improved outcomes.
Trial Registration
Current Controlled Trials ISRCTN11275465; Registered 29 January 2007 (retrospectively registered)
PMCID: PMC5122159  PMID: 27881106
Anorexia nervosa; Adolescents; Family therapy; Multi-family therapy; Randomised controlled trial
21.  Psychotherapy integration under scrutiny: investigating the impact of integrating emotion-focused components into a CBT-based approach: a study protocol of a randomized controlled trial 
BMC Psychiatry  2016;16:423.
This currently recruiting randomized controlled trial investigates the effects of integrating components of Emotion-Focused Therapy (EFT) into Psychological Therapy (PT), an integrative form of cognitive-behavioral therapy in a manner that is directly mirroring common integrative practice in the sense of assimilative integration. Aims of the study are to understand how both, an existing therapy approach as well as the elements to be integrated, are affected by the integration and to clarify the role of emotional processing as a mediator of therapy outcome.
A total of 130 adults with a diagnosed unipolar depressive, anxiety or adjustment disorder (seeking treatment at a psychotherapy outpatient clinic) are randomized to either treatment as usual (PT) with integrated emotion-focused components (TAU + EFT) or PT (TAU). Primary outcome variables are psychopathology and symptom severity at the end of therapy and at follow up; secondary outcome variables are interpersonal problems, psychological wellbeing, quality of life, attainment of individual therapy goals, and emotional competency. Furthermore, process variables such as the quality of the therapeutic relationship are studied as well as aptitude-treatment interactions. Variables are assessed at baseline, after 8 and 16 sessions, at the end of therapy, after 25 ± 3 sessions, and at 6, 12 and 36 month follow-up. Underlying mechanisms of change are investigated. Statistical analyses will be conducted using the appropriate multilevel approaches, mainly two-level regression and growth analysis.
The results of this study will indicate whether the integration of emotion-focused elements into treatment as usual increases the effectiveness of Psychological Therapy. If advantages are found, which may be limited to particular variables or subgroups of patients, recommendations for a systematic integration, and caveats if also disadvantages are detected, can be formulated. On a more abstract level, a cognitive behavioral (represented by PT) and humanistic/experiential (represented by EFT) approach will be integrated. It must be emphasized that mimicking common practice in the development and continued education of psychotherapists, EFT is not integrated as a whole, but only elements of EFT that are considered particularly important, and can be trained in an 8-day training plus supervision of therapies.
Trial registration, NCT02822443, 22 June 2016, retrospectively registered
PMCID: PMC5122165  PMID: 27881113
Emotion-Focused Therapy; Integration; Self-regulation; Psychological Therapy; Cognitive-behavioral therapy; Randomized Controlled Trial
22.  Risk of repeated self-harm and associated factors in children, adolescents and young adults 
BMC Psychiatry  2016;16:421.
Repeated self-harm represents the single strongest risk factor for suicide. To date no study with full national coverage has examined the pattern of hospital repeated presentations due to self-harm among young people.
Data on consecutive self-harm presentations were obtained from the National Self-Harm Registry Ireland. Socio-demographic and behavioural characteristics of individuals aged 10–29 years who presented with self-harm to emergency departments in Ireland (2007–2014) were analysed. Risk of long-term repetition was assessed using survival analysis and time differences between the order of presentations using generalised estimating equation analysis.
The total sample comprised 28,700 individuals involving 42,642 presentations. Intentional drug overdose was the most prevalent method (57.9%). Repetition of self-harm occurred in 19.2% of individuals during the first year following a first presentation, of whom the majority (62.7%) engaged in one repeated act. Overall, the risk of repeated self-harm was similar between males and females. However, in the 20–24-year-old age group males were at higher risk than females. Those who used self-cutting were at higher risk for repetition than those who used intentional drug overdose, particularly among females. Age was associated with repetition only among females, in particular adolescents (15–19 years old) were at higher risk than young emerging adults (20–24 years old). Repeated self-harm risk increased significantly with the number of previous self-harm episodes.
Time differences between first self-harm presentations were detected. Time between second and third presentation increased compared to time between first and second presentation among low frequency repeaters (patients with 3 presentations only within 1 year following a first presentation). The same time period decreased among high frequency repeaters (patients with at least 4 to more than 30 presentations).
Young people with the highest risk for repeated self-harm were 15–19-year-old females and 20–24-year-old males. Self-cutting was the method associated with the highest risk of self-harm repetition. Time between first self-harm presentations represents an indicator of subsequent repetition. To prevent risk of repeated self-harm in young people, all individuals presenting at emergency departments due to self-harm should be provided with a risk assessment including psychosocial characteristics, history of self-harm and time between first presentations.
PMCID: PMC5122208  PMID: 27881107
Self-harm; Repeated self-harm; Young people; Emergency departments; Self-harm methods
23.  Identifying profiles of service users in housing services and exploring their quality of life and care needs 
BMC Psychiatry  2016;16:419.
Housing services aim to support people with mental illness in their daily life and recovery. As the level of recovery differs between service users, the quality of life and care needs also might vary. However, the type and amount of care and support that service users receive do not always match their recovery. In order to improve the quality of care, this study aims to explore whether subgroups of service users exist based on three dimensions of recovery and to examine and compare the quality of life and care needs of the persons in these subgroups.
Latent class analysis was performed with data from 263 service users of housing services in the Netherlands. Classes were based on three variables: personal recovery (Mental Health Recovery Measure), social recovery (Social Functioning Scale), and clinical recovery (Brief Symptom Inventory). Subsequently, the quality of life (MANSA) and care needs (CANSAS) of the different classes were analysed by the use of descriptive and inferential statistics.
Three classes could be distinguished. Class 1 (45%) comprised of people who score the highest of the three classes in terms of personal and social recovery and who experience the least number of symptoms. People in class 2 (44%) and class 3 (11%) score significantly lower on personal and social recovery, and they experience significantly more symptoms compared to class 1. The distinction between class 2 and 3 can be made on the significantly higher number of symptoms in class 3. All three classes differ significantly on quality of life and unmet needs.
The quality of life of service users of housing services needs improvement, as even persons in the best-recovered subgroup have a lower quality of life than the average population. Workers of housing services need to be aware of the recovery of a client and what his or her individual needs and goals are. Furthermore, better care (allocation) concerning mental and physical health and rehabilitation is needed. Care should be provided on all dimensions of recovery at the same time, therefore mental health care organisations should work together and integrate their services.
Trial registration
ISRCTN registry ISRCTN77355880 retrospectively registered 05/07/2013.
PMCID: PMC5120432  PMID: 27881159
Recovery; Rehabilitation; Housing services; Quality of life; Care needs; Severe mental illness
24.  Electrolyte disorders and aging: risk factors for delirium in patients undergoing orthopedic surgeries 
BMC Psychiatry  2016;16:418.
At present, the exact mechanism of postoperative delirium has not been elucidated. The purpose of this study was to analyze the incidence of delirium in patients undergoing orthopedic surgeries and to explore possible related factors.
This is a retrospective study. We used 582 patients who had undergone orthopedic surgery between January 2011 and December 2014. The surgeries consisted of 155 cases of internal fixation for intertrochanteric fracture (IFIF), 128 cases of femoral head replacement (FHR), 169 cases of total hip arthroplasty (THA) and 130 cases of total knee arthroplasty (TKA). Among the 582 patients, 75 developed postoperative delirium (an incidence of 12.9%). The demographics of the patients, which included age, gender, operation duration and blood loss, were statistically analyzed with univariate logistic regression analysis and then multivariate logistic regression. To investigate the influences of different electrolytes disorders for postoperative delirium, the Chi-square test was used.
Multivariate logistic regression analysis indicated that postoperative delirium incidence in patients aged 70–79 years and in patients aged ≥80 years was higher than that in patients aged <70 years, odds ratio (OR) values were 6.33 and 26.37, respectively. In addition, the incidence of postoperative delirium in the group of patients with electrolyte disorders was higher than that in the normal group (OR, 2.38). There were statistically significant differences between the delirium group and the non-delirium group in the incidences of the sodium and calcium disorders.
Aging and postoperative electrolyte disorders (hyponatremia and hypocalcemia) are risk factors for postoperative delirium in patients undergoing orthopedic surgeries.
PMCID: PMC5120472  PMID: 27881118
Orthopedic surgery; Postoperative delirium; Age-related risk factor; Electrolyte disorders
25.  The brief negative symptom scale: validation of the German translation and convergent validity with self-rated anhedonia and observer-rated apathy 
BMC Psychiatry  2016;16:415.
Negative symptoms are considered core symptoms of schizophrenia. The Brief Negative Symptom Scale (BNSS) was developed to measure this symptomatic dimension according to a current consensus definition. The present study examined the psychometric properties of the German version of the BNSS. To expand former findings on convergent validity, we employed the Temporal Experience Pleasure Scale (TEPS), a hedonic self-report that distinguishes between consummatory and anticipatory pleasure. Additionally, we addressed convergent validity with observer-rated assessment of apathy with the Apathy Evaluation Scale (AES), which was completed by the patient’s primary nurse.
Data were collected from 75 in- and outpatients from the Psychiatric Hospital, University Zurich diagnosed with either schizophrenia or schizoaffective disorder. We assessed convergent and discriminant validity, internal consistency and inter-rater reliability.
We largely replicated the findings of the original version showing good psychometric properties of the BNSS. In addition, the primary nurses evaluation correlated moderately with interview-based clinician rating. BNSS anhedonia items showed good convergent validity with the TEPS.
Overall, the German BNSS shows good psychometric properties comparable to the original English version. Convergent validity extends beyond interview-based assessments of negative symptoms to self-rated anhedonia and observer-rated apathy.
PMCID: PMC5118879  PMID: 27876020
Schizophrenia; Negative symptoms; Rating scale; Assessment

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