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1.  Two chromosomal loci involved in production of exopolysaccharide in Agrobacterium tumefaciens. 
Journal of Bacteriology  1989;171(3):1755-1759.
The chromosomal locus pscA (exoC) of Agrobacterium tumefaciens LBA4301 has been cloned by complementation of the avirulent and exopolysaccharide (EPS)-deficient mutant LBA4301 pscA. We have also identified a new locus, termed psdA (polysaccharide depression) and located 16 kilobases from pscA in the A. tumefaciens chromosome, that negatively affects EPS production when it is present in more than one copy in A. tumefaciens LBA4301. Subcloning, transposon mutagenesis, and transcriptional analysis have been conducted for both loci and indicate that pscA and psdA are transcribed in the same orientation. Acidic-EPS assays showed that psdA depresses succinoglycan production and that its negative effect increases with the copy number of the gene. Virulence tests of psdA transconjugants on Datura stramonium showed no visible alteration in virulence, while LBA4301 pscA was totally avirulent.
PMCID: PMC209812  PMID: 2921249
2.  Effectiveness of cognitive behavioural therapy (CBT) interventions for anxiety in patients with chronic obstructive pulmonary disease (COPD) undertaken by respiratory nurses: the COPD CBT CARE study: (ISRCTN55206395) 
Anxiety and depression are common co-morbidities in patients with chronic obstructive pulmonary disease (COPD). Serious implications can result from psychological difficulties in COPD including reduced survival, lower quality of life, and reduced physical and social functioning, increased use of health care resources and are associated with unhealthy behaviours such as smoking. Cognitive behavioural therapy (CBT) is a psychological intervention which is recommended for the treatment of many mental health problems including anxiety and depression. Unfortunately access to trained CBT therapists is limited. The aim of this study is to test the hypothesis that CBT delivered by respiratory nurses is effective in the COPD population. In this paper the design of the Newcastle Chronic Obstructive Pulmonary Disease Cognitive Behavioural Therapy Study (Newcastle COPD CBT Care Study) is described.
This is a prospective open randomised controlled trial comparing CBT with self-help leaflets. The primary outcome measure is the Hospital Anxiety & Depression Scale (HADS) – anxiety subscale. Secondary outcome measures include disease specific quality of life COPD Assessment Tool (CAT), generic quality of life (EQ5D) and HADS-depression subscale. Patients will be followed up at three, six and 12 months following randomisation.
This is the first randomised controlled trial to evaluate the use of cognitive behavioural therapy undertaken by respiratory nurses. Recruitment has commenced and should be complete by February 2014.
Trial registration
Current Controlled Trials, ISRCTN55206395
PMCID: PMC3827881  PMID: 24498939
Anxiety; Chronic obstructive pulmonary disease (COPD); Cognitive behavioural therapy (CBT); Depression; Respiratory nurses
3.  Advance care planning in nursing homes: pre- and post-Patient Self-Determination Act. 
Health Services Research  1998;33(1):101-124.
OBJECTIVES: (1) To identify resident and organizational factors associated with the use of advance care plans pre- and post-implementation of the Patient Self-Determination Act (PSDA), and (2) to identify changes (pre- and post-implementation of the PSDA) in the relationship between these factors and the use of advance care plans. DESIGN: Complex, multistage cluster sampling. SETTING: Ten states were selected for variation in geographic location, Medicaid reimbursement rate, and average staffing patterns. Participants were 4,215 nursing home residents in 268 facilities. PRINCIPAL FINDINGS: Seventeen resident and organizational factors were associated with the use of do-not-resuscitate (DNR) orders in 1990, and 12 resident and organizational factors were associated with their use in 1993. Five factors showed a significant change from 1990 to 1993: activities of daily living (ADL) scores, race, cognitive performance scale (CPS) scores, full-time equivalent (FTE) nurse aides per resident, and bed size. Ten resident and organizational factors were associated with use of do-not-hospitalize (DNH) orders in 1990 and six resident and organizational factors were associated with DNH orders in 1993. Four factors showed a significant change from 1990 to 1993: legal guardian, FTE LPNs per resident, Medicaid census, and forprofit ownership. Five resident and organizational factors were associated with the use of living wills in 1990 and seven resident and organizational factors were associated with the use of living wills in 1993. Four factors showed a significant change from 1990 to 1993: ADL scores, race, length of stay, and for-profit ownership. CONCLUSION: The results indicate that the PSDA may have been successful in increasing the use of advance care plans and in changing the types of residents who use advance care plans. However, they also show that the use of advance care plans is associated with organizational characteristics, indicating that some types of facilities may be more willing and able to address the PSDA mandates.
PMCID: PMC1070249  PMID: 9566180
4.  Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: a randomised controlled trial 
Arthritis Research & Therapy  2011;13(5):R173.
No randomised, controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising (PC) in patients with fibromyalgia. Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy (CBT) and the recommended pharmacological treatment (RPT) compared with treatment as usual (TAU) at the primary care level for the treatment of PC in fibromyalgia patients.
We conducted a six-month, multicenter, randomized, blinded, parallel group, controlled trial in which patients were randomly assigned to one of three study arms: CBT (n = 57), RPT (n = 56) and TAU at the primary care level (n = 56). The major outcome of this study was PC in patients with fibromyalgia. The secondary variables were pain acceptance, depression, anxiety, pain, global function and quality of life.
CBT significantly decreased global PC at the six-month follow-up examination with effect sizes of Cohen's d = 0.73 and 1.01 compared with RPT and TAU, respectively. CBT was also more effective than RPT and TAU at increasing pain acceptance at the six-month follow-up examination (effect sizes of Cohen's d = 0.77 and 0.80, respectively). Compared with RPT and TAU, CBT was more effective at improving global function based on the Fibromyalgia Impact Questionnaire (six-month effect sizes Cohen's d = 0.44 and 0.53, respectively) and quality of life based on the European Quality of Life Scale (six-month effect sizes Cohen's d = 0.11 and 0.40, respectively). There were no differences among the three treatments with regard to pain and depression.
CBT shows higher efficacy than RPT and TAU not only in key outcomes in FM, such as function and quality of life, but also in relevant mediators of treatment effects, such as pain catastrophising and pain acceptance.
Trial registration
PMCID: PMC3308108  PMID: 22018333
catastrophisation; fibromyalgia; randomised controlled trial; cognitive-behaviour therapy
5.  A waitlist-controlled trial of group cognitive behavioural therapy for depression and anxiety in Parkinson’s disease 
BMC Psychiatry  2014;14:19.
The aim of this study was to evaluate the efficacy of a group Cognitive Behavioural Therapy (CBT) treatment for depression and anxiety in Parkinson’s disease (PD).
A waitlist-controlled trial design was used. Eighteen adults with PD and a comorbid DSM-IV-TR diagnosis of depression and/or anxiety were randomised to either Intervention (8-week group CBT treatment) or Waitlist (8-week clinical monitoring preceding treatment). The Depression, Anxiety, Stress Scale-21 (DASS-21) was the primary outcome. Assessments were completed at Time 1 (pretreatment), Time 2 (posttreatment/post-waitlist) and 1-month and 6-month follow-ups.
At Time 2, participants who received CBT reported greater reductions in depression (Mchange = -2.45) than Waitlist participants (Mchange = .29) and this effect was large, d = 1.12, p = .011. Large secondary effects on anxiety were also observed for CBT participants, d = .89, p = .025. All treatment gains were maintained and continued to improve during the follow-up period. At 6-month follow-up, significant and large effects were observed for both depression (d = 2.07) and anxiety (d = 2.26).
Group CBT appears to be an efficacious treatment approach for depression and anxiety in PD however further controlled trials with larger numbers of participants are required.
Trial registration
Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12610000455066)
PMCID: PMC3907935  PMID: 24467781
Depression; Anxiety; Parkinson’s disease; Cognitive behavioural therapy; Psychotherapy; Treatment; Randomised controlled trial
6.  Internet-based cognitive behavior therapy for obsessive compulsive disorder: A pilot study 
BMC Psychiatry  2011;11:125.
Cognitive behavior therapy (CBT) is widely regarded as an effective treatment for obsessive compulsive disorder (OCD), but access to CBT therapists is limited. Internet-based CBT (ICBT) with therapist support is a way to increase access to CBT but has not been developed or tested for OCD. The aim of this study was to evaluate ICBT for OCD.
An open trial where patients (N = 23) received a 15-week ICBT program with therapist support consisting of psychoeducation, cognitive restructuring and exposure with response prevention. The primary outcome was the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), which was assessed by a psychiatrist before and immediately after treatment. Secondary outcomes were self-rated measures of OCD symptoms, depressive symptoms, general functioning, anxiety and quality of life. All assessments were made at baseline and post-treatment.
All participants completed the primary outcome measure at all assessment points. There were reductions in OCD symptoms with a large within-group effect size (Cohen's d = 1.56). At post-treatment, 61% of participants had a clinically significant improvement and 43% no longer fulfilled the diagnostic criteria of OCD. The treatment also resulted in statistically significant improvements in self-rated OCD symptoms, general functioning and depression.
ICBT with therapist support reduces OCD symptoms, depressive symptoms and improves general functioning. Randomized trials are needed to confirm the effectiveness of this new treatment format.
Trial Registration NCT01348529
PMCID: PMC3163522  PMID: 21812991
Cognitive behavior therapy; Internet; obsessive compulsive disorder
7.  The economic impact of stroke in The Netherlands: the €-restore4stroke study 
BMC Public Health  2012;12:122.
Stroke has a considerable socio-economic impact worldwide and is the leading cause of disabilities in the Western world. Economic studies of stroke focus merely on physical aspects and clinical interventions. To our current knowledge there is no comprehensive economic study investigating the economic impact of stroke including psychological and social aspects. The €-Restore4Stroke project, part of a large comprehensive research programme Restore4Stroke, aims to investigate the total economic impact of stroke in the Netherlands.
Two trial-based economic evaluation studies will be conducted within the €-Restore4Stroke project: one focussing on a self-management intervention and one on an augmented cognitive behavioural therapy intervention. Both include cost-effectiveness analyses and cost-utility analyses as primary research methods. Furthermore, a cost-of-illness study investigating costs after stroke attached to a cohort study and a record linkage study in which four databases are linked to investigate patterns of health care consumption before and after stroke, are embedded in €-Restore4Stroke. All studies will be performed from a societal perspective. The primary outcome measure for the cost-effectiveness analysis is the increase in health status on the primary outcome scales. Within the cost-utility analysis, the primary outcome measure is quality-adjusted life years (QALYs) for which an indirect preference-based technique will be used. In the self-management study we will also look at the estimation of health effects on informal caregivers. Cost outcomes in the cost-of-illness study will be computed with a cost questionnaire and linkage of several databases will be used to derive outcomes in the record linkage study,
€-Restore4Stroke will provide new insights and evidence for the economic impact of psychosocial consequences after stroke. Besides being innovative in various ways (i.e. focussing on the chronic phase after stroke and including personal factors as possible determinants of long-term re-integration including quality of life in a prospective longitudinal design), a major strength of €-Restore4Stroke is that we include impact on informal caregivers. The outcomes of this study will provide health care decision makers with valuable and necessary information regarding stroke care related decisions.
Trial registration
NTR3051 (RCT Self-management), NTR2999 (RCT Augmented Cognitive Behavioural Therapy)
PMCID: PMC3305460  PMID: 22329910
8.  The effectiveness of cognitive behavioral therapy on the quality of life of patients with inflammatory bowel disease: multi-center design and study protocol (KL!C- study) 
BMC Psychiatry  2012;12:227.
Inflammatory Bowel Disease (IBD) patients report poorer quality of life (QoL) and more anxiety and depressive symptoms than controls from the general population. Cognitive behavioral therapy (CBT) is effective for anxiety and depression, but questionable in case of co-morbidity with IBD. Therefore, an adapted new CBT specifically designed for IBD patients was developed. The objective of this study is to evaluate the effectiveness of adapted CBT on QoL.
IBD patients with a poor level of mental QoL (score less than or equal to 23 on the mental health scale of SF-36) will be randomly assigned to the experimental (n = 40) or waiting-list control condition (n = 40). The experimental condition will then immediately start CBT. The waiting-list control condition will wait 3,5 months before CBT begins with pre- and post assessments. Both conditions will complete a baseline and follow-up assessment following CBT and a mid-treatment assessment. The primary outcome is IBD-specific QoL (IBDQ). Secondary outcomes are generic QoL (SF-36) and anxiety and depression complaints (HADS, CES-D). Additionally, we will examine the working mechanism of the psychological intervention by investigating the impact of the intervention on illness-related cognitions, attitudes, coping styles and their associations with outcome. Data will be analysed on an intention to treat (ITT) as well as treatment completer basis (greater than or equal to five sessions followed).
If found effective, this IBD-specific CBT is a first step to enhance poor QoL in IBD patients and possibly, other gastroenterological diseases. By enhancing IBD patients’ QoL, we may also improve their mental and physical health, and lower unnecessary health care consumption.
Trial registration number
NTR (TC = 1869)
PMCID: PMC3570397  PMID: 23237076
Inflammatory Bowel Disease; Cognitive behavioral therapy; Quality of life; Anxiety; Depression
9.  Cognitive behavioral therapy in anxiety disorders: current state of the evidence 
A plethora of studies have examined the efficacy and effectiveness of cognitive-behavioral therapy (CBT) for adult anxiety disorders. In recent years, several meta-analyses have been conducted to quantitatively review the evidence of CBT for anxiety disorders, each using different inclusion criteria for studies, such as use of control conditions or type of study environment. This review aims to summarize and to discuss the current state of the evidence regarding CBT treatment for panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Overall, CBT demonstrates both efficacy in randomized controlled trials and effectiveness in naturalistic settings in the treatment of adult anxiety disorders. However, due to methodological issues, the magnitude of effect is currently difficult to estimate. In conclusion, CBT appears to be both efficacious and effective in the treatment of anxiety disorders, but more high-quality studies are needed to better estimate the magnitude of the effect.
PMCID: PMC3263389  PMID: 22275847
cognitive-behavioral therapy; psychotherapy; meta-analysis; anxiety disorder; panic disorder; generalized anxiety disorder; obsessive-compulsive disorder; acute stress disorder; post-traumatic stress disorder
10.  The United States Revised Uniform Anatomical Gift Act (2006): New challenges to balancing patient rights and physician responsibilities 
Advance health care directives and informed consent remain the cornerstones of patients' right to self-determination regarding medical care and preferences at the end-of-life. However, the effectiveness and clinical applicability of advance health care directives to decision-making on the use of life support systems at the end-of-life is questionable. The Uniform Anatomical Gift Act (UAGA) has been revised in 2006 to permit the use of life support systems at or near death for the purpose of maximizing procurement opportunities of organs medically suitable for transplantation. Some states have enacted the Revised UAGA (2006) and a few of those have included amendments while attempting to preserve the uniformity of the revised Act. Other states have introduced the Revised UAGA (2006) for legislation and remaining states are likely to follow soon.
The Revised UAGA (2006) poses challenges to the Patient Self Determination Act (PSDA) embodied in advance health care directives and individual expression about the use of life support systems at the end-of-life. The challenges are predicated on the UAGA revising the default choice to presumption of donation intent and the use of life support systems to ensure medical suitability of organs for transplantation. The default choice trumps the expressed intent in an individual's advance health care directive to withhold and/or withdraw life support systems at the end-of-life. The Revised UAGA (2006) overrides advance directives on utilitarian grounds, which is a serious ethical challenge to society. The subtle progression of the Revised UAGA (2006) towards the presumption about how to dispose of one's organs at death can pave the way for an affirmative "duty to donate". There are at least two steps required to resolve these challenges. First, physicians and hospitals must fulfill their responsibilities to educate patients on the new legislations and document their preferences about the use of life support systems for organ donation at the end-of-life. Second, a broad based societal discussion must be initiated to decide if the Revised UAGA (2006) infringes on the PSDA and the individual's right of autonomy. The discussion should also address other ethical concerns raised by the Revised UAGA (2006), including the moral stance on 1) the interpretation of the refusal of life support systems as not applicable to organ donation and 2) the disregarding of the diversity of cultural beliefs about end-of-life in a pluralistic society.
PMCID: PMC2001294  PMID: 17850664
11.  Meta-analysis Comparing Different Behavioral Treatments for Late-Life Anxiety 
To evaluate the efficacy of different types of behavioral treatments for geriatric anxiety [cognitive-behavioral therapy (CBT) alone, CBT with relaxation training (RT), and RT alone].
We compared effect sizes from 19 trials. Analyses were based on uncontrolled outcomes (comparing post-treatment and pre-treatment scores) and effects relative to control conditions on both anxiety and depressive symptoms.
Treatments for older adults with anxiety symptoms were, on average, more effective than active control conditions. Effect sizes were comparable to those reported elsewhere for CBT for anxiety in the general population or for pharmacotherapy in anxious older adults. CBT (alone or augmented with RT) does not appear to add anything beyond RT alone, although a direct comparison is challenging given differences in control conditions. Effects on depressive symptoms were smaller, with no differences among treatment types.
Results suggest that behavioral treatments are effective for older adults with anxiety disorders and symptoms. Results must be interpreted with caution given the limitations of the literature, including differing sample characteristics and control conditions across studies.
PMCID: PMC2794407  PMID: 19155744
Psychotherapy; Geriatric; Anxiety; Relaxation Training; Cognitive Behavioral Therapy
12.  Group Training of Stress Management vs. Group Cognitive-Behavioral Therapy in Reducing Depression, Anxiety and Perceived Stress Among HIV-Positive Men 
Objective: To compare the effectiveness of group training of stress management with cognitive-behavioral therapy (CBT) in reducing depression, anxiety and stress perceived among HIV-positive men.
Methods:Inthis semi-experimental study, three groups of HIV-positive men (CBT group, stress management group, and control group) including 15 patients in each group were compared regarding depression, anxiety, and stress using pre-test and post-test tools.
Results: Both interventions (CBT and stress management) were effective in reducing depression, anxiety and perceived stress. Evaluating adjustedmean showed the more effectivenessofthe group stressmanagementtraining than CBT.
Conclusion: Group stress management training is more effective than group CBT in HIV-positive mentodecreasedepression, anxiety and stress management.
Declaration of interest: None.
Clinical Trial Registration: URL: Unique identifier: 2012121711782N1
PMCID: PMC3939984  PMID: 24644493
Anxiety; Cognitive-Behavioral Therapy (CBT); Depression; Group Training of Stress Management; HIV
13.  Study design of 'FRIENDS for Life': process and effect evaluation of an indicated school-based prevention programme for childhood anxiety and depression 
BMC Public Health  2012;12:86.
Anxiety disorders and depression are highly prevalent in children and affect their current and future functioning. 'FRIENDS for Life' is a cognitive-behavioural programme teaching children skills to cope more effectively with feelings of anxiety and depression. Although 'FRIENDS for Life' is increasingly being implemented at Dutch schools, its effectiveness as a preventive intervention in Dutch schools has never been investigated. The aim of the study is to evaluate the effectiveness of 'FRIENDS for Life' as an indicated school-based prevention programme for children with early or mild signs of anxiety or depression.
This study is a controlled trial with one pre-intervention and three post-intervention measurements (directly after, and 6 and 12 months after the end of the programme). The study sample consists of children aged 10-12 years (grades 6, 7 and 8 of Dutch primary schools), who show symptoms of anxiety or depressive disorder. Data are collected through self-report, teacher report and peer nomination. A process evaluation is conducted to investigate programme integrity (whether the programme has been executed according to protocol) and to evaluate children's and parents' opinions about 'FRIENDS for Life' using online focus groups and interviews.
The present study will provide insight into the effectiveness of 'FRIENDS for Life' as an indicated school-based prevention programme for children with early or mild signs of anxiety or depression.
Trial registration
Netherlands Trial Register (NTR): NTR2397
PMCID: PMC3292977  PMID: 22284741
Prevention; School-based intervention; Anxiety; Depression; Children; FRIENDS for Life; Cognitive-behavioural therapy
14.  Cost-effectiveness of a structured progressive task-oriented circuit class training programme to enhance walking competency after stroke: The protocol of the FIT-Stroke trial 
BMC Neurology  2009;9:43.
Most patients who suffer a stroke experience reduced walking competency and health-related quality of life (HRQoL). A key factor in effective stroke rehabilitation is intensive, task-specific training. Recent studies suggest that intensive, patient-tailored training can be organized as a circuit with a series of task-oriented workstations.
Primary aim of the FIT-Stroke trial is to evaluate the effects and cost-effectiveness of a structured, progressive task-oriented circuit class training (CCT) programme, compared to usual physiotherapeutic care during outpatient rehabilitation in a rehabilitation centre. The task-oriented CCT will be applied in groups of 4 to 6 patients. Outcome will be defined in terms of gait and gait-related ADLs after stroke. The trial will also investigate the generalizability of treatment effects of task-oriented CCT in terms of perceived fatigue, anxiety, depression and perceived HRQoL.
The multicentre single-blinded randomized trial will include 220 stroke patients discharged to the community from inpatient rehabilitation, who are able to communicate and walk at least 10 m without physical, hands-on assistance. After discharge from inpatient rehabilitation, patients in the experimental group will receive task-oriented CCT two times a week for 12 weeks at the physiotherapy department of the rehabilitation centre. Control group patients will receive usual individual, face-to-face, physiotherapy. Costs will be evaluated by having each patient keep a cost diary for the first 24 weeks after randomisation. Primary outcomes are the mobility part of the Stroke Impact Scale (SIS-3.0) and the EuroQol. Secondary outcomes are the other domains of SIS-3.0, lower limb muscle strength, walking endurance, gait speed, balance, confidence not to fall, instrumental ADL, fatigue, anxiety, depression and HRQoL.
Based on assumptions about the effect of intensity of practice and specificity of treatment effects, FIT-Stroke will address two key aims. The first aim is to investigate the effects of task-oriented CCT on walking competency and HRQoL compared to usual face-to-face physiotherapy. The second aim is to reveal the cost-effectiveness of task-oriented CCT in the first 6 months post stroke. Both aims were recently recommended as priorities by the American Hearth Association and Stroke Council.
Trial registration
This study is registered in the Dutch Trial Register as NTR1534.
PMCID: PMC2736157  PMID: 19674485
15.  A Randomized Controlled Trial of Telephone-Delivered Cognitive-Behavioral Therapy for Late-life Anxiety Disorders 
Older adults face a number of barriers to receiving psychotherapy, such as a lack of transportation and access to providers. One way to overcome such barriers is to provide treatment by telephone. The purpose of this study was to examine the effects of cognitive behavioral therapy delivered by telephone (CBT-T) to older adults diagnosed with an anxiety disorder.
Randomized controlled trial.
Participants' homes.
Sixty participants ≥ 60 years of age with a diagnosis of Generalized Anxiety Disorder, Panic Disorder, or Anxiety Disorder Not Otherwise Specified.
CBT-T vs. information-only comparison.
Co-primary outcomes included worry (Penn State Worry Questionnaire) and general anxiety (State Trait Anxiety Inventory). Secondary outcomes included clinician-rated anxiety (Hamilton Anxiety Rating Scale), anxiety sensitivity (Anxiety Sensitivity Index), depressive symptoms (Beck Depression Inventory), quality of life (SF-36), and sleep (Insomnia Severity Index). Assessments were completed prior to randomization, immediately upon completion of treatment, and 6 months after completing treatment.
CBT-T was superior to information-only in reducing general anxiety (ES = 0.71), worry (ES = 0.61), anxiety sensitivity (ES = 0.85), and insomnia (ES = 0.82) at the post-treatment assessment; however, only the reductions in worry were maintained by the 6 month follow-up assessment (ES = 0.80).
These results suggest that CBT-T may be efficacious in reducing anxiety and worry in older adults, but additional sessions may be needed to maintain these effects.
PMCID: PMC3407971  PMID: 22828172
anxiety; cognitive-behavioral therapy; elderly; Generalized Anxiety Disorder; Panic Disorder; telephone-delivered psychotherapy
16.  Quality of life of elderly ischaemic stroke patients one year after thrombolytic therapy. A comparison between patients with and without thrombolytic therapy 
BMC Neurology  2012;12:61.
An observational study to examine whether thrombolytic therapy in stroke patients realizes better quality of life outcomes compared to patients without thrombolytic therapy one year after stroke. We also examined whether daily functioning, mental functioning and activities improved after thrombolytic treatment.
A total of 88 stroke patients were interviewed at home one year post-stroke. Health-related quality of life (HRQOL) was assessed using the RAND-36, disability with the Barthel Index, depression and anxiety with the Hospital Anxiety and Depression Scale, and a questionnaire about patient way of life was completed. People aged under 60, moving to a nursing home or with a haemorrhage were excluded.
The thrombolysis group (TG) had more severe stroke (higher NIHSS) scores and were younger than the group without thrombolytic therapy (WTG). The primary outcome was HRQOL, which was high and nearly identical in both groups, however the TG had significantly better HRQOL for the ‘mental health’ and ‘vitality’ scales. Patients who stopped or reduced their hobbies because of stroke had a significantly worse HRQOL.
One year after stroke, more patients in the TG were totally or severely ADL dependent (12% TG and 0% WTG, p = 0.022). The level of dependence decreased in the TG (p = 0.042) and worsened in the WTG (p < 0.001) after one year. Being more dependent is related to diminishing daily occupations in both groups. In the TG the level of dependence had less impact on visiting family and friends and going on holiday. The prevalence of anxiety disorder and depression was low compared to other studies and there is no significant difference between the two groups.
No major differences in the primary outcome (HRQOL) could be found between the two groups. In addition, no essential difference could be found in mental functioning and participation. We expected that patients undergoing thrombolytic therapy would have worse quality of life because of the greater initial severity of their stroke. Therefore, thrombolytic therapy seems to be of great importance in achieving better quality of life in ischemic stroke patients who respond to this therapy.
PMCID: PMC3444943  PMID: 22835054
17.  The effect of a web-based depression intervention on suicide ideation: secondary outcome from a randomised controlled trial in a helpline 
BMJ Open  2013;3(6):e002886.
The effect of web-based interventions for depression on suicide ideation in callers to helplines is not known. The aim of this study was to determine if web-based Cognitive Behaviour Therapy (CBT) with and without telephone support is effective in reducing suicide ideation in callers to a helpline compared with treatment as usual (TAU). A secondary aim was to examine the factors that predict change in suicide ideation. Putative predictors included level of baseline depression, suicide behaviour, baseline anxiety and type of intervention.
Randomised controlled trial.
Lifeline, Australia's 24 h telephone counselling service participants: 155 callers to a national helpline service with moderate-to-high psychological distress.
Participants were recruited and randomised to receive either 6 weeks of internet CBT plus weekly telephone follow-up; internet CBT only; weekly telephone follow-up only or a wait-list TAU control group.
Primary and secondary outcome measures
Suicidal ideation was measured using four items from the 28-item General Health Questionnaire. Predictors of change in ideation were tested using logistic regression analysis.
Regardless of the intervention condition, participants showed significant reductions in suicidal ideation over 12 months (p<0.001). Higher baseline suicidal behaviour decreased the odds of remission of suicidal ideation at postintervention (OR 0.409, p<0.001). However, change in depression over the course of the interventions was associated with improvement in suicide ideation (OR 1.165, p<0.001).
Suicide ideation declines with and without proactive intervention. Improvements in depression are associated with the resolution of suicide ideation. Specific interventions focusing on suicide ideation should be further investigated.
Trial registration ISRCTN93903959.
PMCID: PMC3696875  PMID: 23811172
Internet; Telephone
18.  Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: Design of a randomised trial 
BMC Public Health  2008;8:224.
Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost-) effectiveness of online computerised cognitive behavioural therapy for depression in primary care.
In a randomised trial we will compare (a) computerised cognitive behavioural therapy with (b) treatment as usual by a GP, and (c) computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18–65) will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000). Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life.
Although computerised cognitive behavioural therapy is a promising treatment for depression in primary care, more research is needed. The effectiveness of online computerised cognitive behavioural therapy without support remains to be evaluated as well as the effects of computerised cognitive behavioural therapy in combination with usual GP care. Economic evaluation is also needed. Methodological strengths and weaknesses are discussed.
Trial registration
The study has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236).
PMCID: PMC2474681  PMID: 18590518
19.  Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial 
Trials  2011;12:95.
Several studies have showed that people with intellectual disabilities (ID) have suitable skills to undergo cognitive behavioural therapy (CBT). Case studies have reported successful use of cognitive behavioural therapy techniques (with adaptations) in people with ID. Modified cognitive behavioural therapy may be a feasible and effective approach for the treatment of depression, anxiety, and other mood disorders in ID. To date, two studies have reported group-based manaulised cognitive behavioural treatment programs for depression in people with mild ID. However, there is no individual manualised programme for anxiety or depression in people with intellectual disabilities. The aims of the study are to determine the feasibility of conducting a randomised controlled trial for CBT in people with ID. The data will inform the power calculation and other aspects of carrying out a definitive randomised controlled trial.
Thirty participants with mild ID will be allocated randomly to either CBT or treatment as usual (TAU). The CBT group will receive up to 20 hourly individual CBT over a period of 4 months. TAU is the standard treatment which is available to any adult with an intellectual disability who is referred to the intellectual disability service (including care management, community support, medical, nursing or social support). Beck Youth Inventories (Beck Anxiety Inventory & Beck Depression Inventory) will be administered at baseline; end of treatment (4 months) and at six months to evaluate the changes in depression and anxiety. Client satisfaction, quality of life and the health economics will be secondary outcomes.
The broad outcome of the study will be to produce clear guidance for therapists to apply an established psychological intervention and identify how and whether it works with people with intellectual disabilities.
Trial registration
PMCID: PMC3102627  PMID: 21492437
20.  Randomized controlled trial of computerized cognitive behavioural therapy for depressive symptoms: effectiveness and costs of a workplace intervention 
Psychological Medicine  2013;44(4):741-752.
Depression and anxiety are major causes of absence from work and underperformance in the workplace. Cognitive behavioural therapy (CBT) can be effective in treating such problems and online versions offer many practical advantages. The aim of the study was to investigate the effectiveness of a computerized CBT intervention (MoodGYM) in a workplace context.
The study was a phase III two-arm, parallel randomized controlled trial whose main outcome was total score on the Work and Social Adjustment Scale (WSAS). Depression, anxiety, psychological functioning, costs and acceptability of the online process were also measured. Most data were collected online for 637 participants at baseline, 359 at 6 weeks marking the end of the intervention and 251 participants at 12 weeks post-baseline.
In both experimental and control groups depression scores improved over 6 weeks but attrition was high. There was no evidence for a difference in the average treatment effect of MoodGYM on the WSAS, nor for a difference in any of the secondary outcomes.
This study found no evidence that MoodGYM was superior to informational websites in terms of psychological outcomes or service use, although improvement to subthreshold levels of depression was seen in nearly half the patients in both groups.
PMCID: PMC3898729  PMID: 23795621
CBT; depression; stress; workplace
21.  A systematic review investigating fatigue, psychological and cognitive impairment following TIA and minor stroke: protocol paper 
Systematic Reviews  2013;2:72.
Approximately 20,000 people have a transient ischemic attack (TIA) and 23,375 have a minor stroke in England each year. Fatigue, psychological and cognitive impairments are well documented post-stroke. Evidence suggests that TIA and minor stroke patients also experience these impairments; however, they are not routinely offered relevant treatment. This systematic review aims to: (1) establish the prevalence of fatigue, anxiety, depression, post-traumatic stress disorder (PTSD) and cognitive impairment following TIA and minor stroke and to investigate the temporal course of these impairments; (2) explore impact on quality of life (QoL), change in emotions and return to work; (3) identify where further research is required and to potentially inform an intervention study.
A systematic review of MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane libraries and grey literature between January 1993 and April 2013 will be undertaken. Two reviewers will conduct screening search results, study selection, data extraction and quality assessment. Studies of adult TIA and minor stroke participants containing any of the outcomes of interest; fatigue, anxiety, depression, PTSD or cognitive impairment will be included. Studies at any time period after TIA/minor stroke, including those with any length of follow-up, will be included to investigate the temporal course of impairments. QoL, change in emotions and return to work will also be documented. The proportion of TIA or minor stroke participants experiencing each outcome will be reported.
If appropriate, a meta-analysis will pool results of individual outcomes. Studies will be grouped and analyzed according to their follow-up timeframe into short-term (< 3 months after TIA/minor stroke), medium-term (3 to 12 months) and long term (> 12 months). Sub-analysis of studies with a suitable control group will be conducted. Exploratory sub-analysis of memory and attention domains of cognitive impairment will be conducted.
The current treatment goal for TIA and minor stroke patients is secondary stroke prevention. If these patients do experience fatigue, psychological or cognitive impairments then this treatment alone is unlikely to be sufficient. The results of this comprehensive review will increase understanding of treatment needs for this patient group, identify where further research is required and potentially inform an intervention trial.
PMCID: PMC3846122  PMID: 24011357
Transient ischemic attack; Minor stroke; Reversible ischemic neurologic deficit; Fatigue; Anxiety; Depression; Post-traumatic stress disorder; Cognitive impairment; Quality of life
22.  Meta-review of the effectiveness of computerised CBT in treating depression 
BMC Psychiatry  2011;11:131.
Several computerised cognitive behaviour therapy (cCBT) packages are now available to treat mild to moderate depression with or without anxiety. These have been usually been reviewed alongside cCBT for a wide range of psychological problems. Here, we single out the results of these reviews for the most common mental disorder, mild to moderate depression. The aim of this paper is to evaluate the quality of existing reviews and to enable reliable comparisons of alternative computer packages for the same patient group.
A thorough search and analysis of reviews of efficacy of cCBT published between 1999 and February 2011.
The search yielded twelve systematic reviews from ten studies covering depression. Their methodology is appraised and selected findings are presented here.
The meta-review supports the efficacy of cCBT for treatment of depression; however there is limited information on different approaches, whose relative cost-effectiveness remains to be demonstrated. Suggestions are made for future studies in the field.
PMCID: PMC3180363  PMID: 21838902
23.  Comparison of two depression measures for predicting stroke outcomes 
Journal of psychosomatic research  2012;72(3):175-179.
Little is known about the effect of lifetime history of depression on ischemic stroke outcomes. This study compared a measure of current symptoms of depression at the time of the stroke and a measure of lifetime history of depression for their ability to predict quality of life and functioning at 3 and 12 months after stroke.
A cohort of 460 ischemic stroke patients from the 2005 Greater Cincinnati/North Kentucky Stroke Study was assessed within 2 weeks of the stroke, including the 10-item Center for Epidemiological Studies Depression Scale (CESD) for current symptoms of depression. Lifetime history of depression was also assessed by a 2-question measure at 3 and 12 months after stroke. Two outcome measures, Stroke Specific Quality of Life (SSQOL) and the modified Rankin Scale (mRS) to assess functional status, were also collected at 3 and 12 months.
Of the 322 survivors included in the analysis, 52.2% reported depression on at least one measure. Both current symptoms and lifetime history of depression predicted poor functional outcomes and poor quality of life at 3 and 12 months, after adjustment for age, race, sex, prior stroke, baseline functional status, and stroke severity. The combination of depression measures was a better predictor of poor outcomes than either measure alone.
Depression by either measure was a frequent, substantial, and independent predictor of poor outcomes at 3 and 12 months after stroke. Stroke outcomes studies should further examine the predictive value of assessing both depressive symptoms at the time of the stroke and lifetime history of depression.
PMCID: PMC3742310  PMID: 22325695
Depression symptoms; Functioning; History of depression; Quality of life; Stroke; Stroke outcomes
24.  A preliminary study of individual cognitive behavior therapy for social anxiety disorder in Japanese clinical settings: a single-arm, uncontrolled trial 
BMC Research Notes  2013;6:74.
Cognitive behavior therapy (CBT) is regarded as an effective treatment for social anxiety disorder (SAD) in Europe and North America. Individual CBT might be acceptable and effective for patients with SAD even in non-Western cultures; therefore, we conducted a feasibility study of individual CBT for SAD in Japanese clinical settings. We also examined the baseline predictors of outcomes associated with receiving CBT.
This single-arm trial employed a 14-week individual CBT intervention. The primary outcome was the self-rated Liebowitz Social Anxiety Scale, with secondary measurements of other social anxiety and depressive severity. Assessments were conducted at baseline, after a waiting period before CBT, during CBT, and after CBT.
Of the 19 subjects screened, 15 were eligible for the study and completed the outcome measures at all assessment points. Receiving CBT led to significant improvements in primary and secondary SAD severity (ps < .001). The mean total score on the Liebowitz Social Anxiety Scale improved from 91.8 to 51.7 (before CBT to after CBT), and the within-group effect size at the end-point assessment was large (Cohen’s d = 1.71). After CBT, 73% of participants were judged to be treatment responders, and 40% met the criteria for remission. We found no significant baseline predictors of those outcomes.
Despite several limitations, our treatment—which comprises a 14-week, individual CBT program—seems feasible and may achieve favorable treatment outcomes for SAD in Japanese clinical settings. Further controlled trials are required in order to address the limitations of this study.
Trial registration
UMIN-CTR UMIN000005897
PMCID: PMC3602169  PMID: 23448435
Cognitive behavioral therapy; CBT; Social anxiety disorder; Social phobia; SAD; Japanese
25.  Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial 
Trials  2013;14:437.
Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effects of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a smartphone application. The effect of added therapist support will also be studied.
One hundred and fifty participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to either one of three study groups: 1, smartphone-supplemented iCBT with therapist support; 2, smartphone-supplemented iCBT without therapist support; or 3, an active waiting list control group with delayed treatment. Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment (days 24 and 48) and two follow-up assessments (12 and 36 months) to assess rapid and long-term effects.
To our knowledge, this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders. Hence, the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions. Limitations are discussed.
Trial registration NCT01963806
PMCID: PMC3878326  PMID: 24351088
Smartphone; Application; App; Cognitive behavioural; Internet-administered; Anxiety; Randomised controlled trial

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