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1.  Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial 
Trials  2013;14:221.
Background
Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations.
Methods and study design
This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up.
Discussion
This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group.
Trial registration
ISRCTN58561170
doi:10.1186/1745-6215-14-221
PMCID: PMC3718639  PMID: 23866771
2.  Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial 
Trials  2013;14:82.
Background
Seasonal affective disorder (SAD) is a subtype of recurrent depression involving major depressive episodes during the fall and/or winter months that remit in the spring. The central public health challenge in the management of SAD is prevention of winter depression recurrence. Light therapy (LT) is the established and best available acute SAD treatment. However, long-term compliance with daily LT from first symptom through spontaneous springtime remission every fall/winter season is poor. Time-limited alternative treatments with effects that endure beyond the cessation of acute treatment are needed to prevent the annual recurrence of SAD.
Methods/design
This is an NIMH-funded R01-level randomized clinical trial to test the efficacy of a novel, SAD-tailored cognitive-behavioral group therapy (CBT) against LT in a head-to-head comparison on next winter outcomes. This project is designed to test for a clinically meaningful difference between CBT and LT on depression recurrence in the next winter (the primary outcome). This is a concurrent two-arm study that will randomize 160 currently symptomatic community adults with major depression, recurrent with seasonal pattern, to CBT or LT. After 6 weeks of treatment in the initial winter, participants are followed in the subsequent summer, the next winter, and two winters later. Key methodological issues surround timing study procedures for a predictably recurrent and time-limited disorder with a focus on long-term outcomes.
Discussion
The chosen design answers the primary question of whether prior exposure to CBT is associated with a substantially lower likelihood of depression recurrence the next winter than LT. This design does not test the relative contributions of the cognitive-behavioral treatment components vs. nonspecific factors to CBT’s outcomes and is not adequately powered to test for differences or equivalence between cells at treatment endpoint. Alternative designs addressing these limitations would have required more patients, increased costs, and reduced power to detect a difference in the primary outcome.
Trial registration
Clinicaltrials.gov identifier NCT01714050
doi:10.1186/1745-6215-14-82
PMCID: PMC3652773  PMID: 23514124
Seasonal affective disorder; Clinical trial; Cognitive-behavioral therapy; Light therapy; Depression recurrence; Prevention
3.  An Open Trial of Sustained Release Bupropion for Attention-Deficit/Hyperactivity Disorder in Adults with ADHD plus Substance Use Disorders 
Objective
To evaluate the effectiveness and tolerability of bupropion in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) and comorbid active Substance Use Disorders (SUD).
Methods
This was a six-week open trial of sustained-release (SR) bupropion in adults aged 18 to 55 years diagnosed with both ADHD and SUD. Bupropion-SR was initiated at 100 mg SR and increased weekly to a target dose of 200 mg SR twice daily. Subjects were assessed on multiple outcomes including ADHD, SUD, and adverse effects. All analyses were intent to treat, with last observation carried forward.
Results
Thirty-two subjects were treated with bupropion, with nineteen subjects completing the entire protocol (59%). At end point there were clinically significant reductions in the ADHD RS (34.1±8.2 to 19.4±11.4, −43%, t=6.49, p<0.0001) and the Clinical Global Impression (CGI) of ADHD severity (baseline=5.0, endpoint=3.8, −24%, t=6.16, p<0.0001). In contrast, there were clinically negligible effects on the self-report of substance use (p’s >0.05) and on the overall CGI of SUD severity (−23%, t=4.95, p<0.0001).
Conclusions
Results from this open trial suggest that in adults with ADHD and SUD, treatment with bupropion-SR is associated with clinically significant reductions in ADHD, but not SUD.
PMCID: PMC3322541  PMID: 22500195
bupropion; ADHD; substance-use disorders
4.  Impact of executive function deficits in youth with bipolar I disorder: a controlled study 
Psychiatry research  2011;186(1):58-64.
Although psychometrically-defined executive function deficits (EFDs) and ecologically valid functional outcomes have been documented among youth with bipolar I (BP-I) disorder, little is known about their association. We hypothesized that EFDs would be associated with significant ecologically valid impairments beyond those predicted by having BP-I disorder. Youth with BP-I disorder were ascertained from psychiatric clinics and community sources. We defined EFDs as having at least two out of eight EF measures impaired from a battery of six tests. Significantly more youth with BP-I disorder had EFDs than controls (45% versus 17%). Comparisons were made between controls without EFDs (N=81), controls with EFDs (N=17), BP-I youth without EFDs (N=76), and BP-I youth with EFDs (N=62). EFDs were associated with an increased risk for placement in a special class and a decrease in academic achievement (WRAT-3 reading and arithmetic). EFDs in BP-I subjects were associated with an increased risk for speech/language disorder (as assessed in the K-SADS-E) relative to BP-I subjects without EFDs. Youth with BP-I disorder and EFDs are at high risk for significant impairments in academic functioning.
doi:10.1016/j.psychres.2010.08.029
PMCID: PMC3026851  PMID: 20864180
mania; children; cognition; neuropsychology
5.  Treading carefully: a qualitative ethnographic study of the clinical, social and educational uses of exercise ECG in evaluating stable chest pain 
BMJ Open  2012;2(1):e000508.
Objective
To examine functions of the exercise ECG in the light of the recent National Institute for Health and Clinical Excellence guidelines recommending that it should not be used for the diagnosis or exclusion of stable angina.
Design
Qualitative ethnographic study based on interviews and observations of clinical practice.
Setting
3 rapid access chest pain clinics in England.
Participants
Observation of 89 consultations in chest pain clinics, 18 patient interviews and 12 clinician interviews.
Main outcome measure
Accounts and observations of consultations in chest pain clinics.
Results
The exercise ECG was observed to have functions that extended beyond diagnosis. It was used to clarify a patient's story and revise the initial account. The act of walking on the treadmill created an additional opportunity for dialogue between clinician and patient and engagement of the patient in the diagnostic process through precipitation of symptoms and further elaboration of symptoms. The exercise ECG facilitated reassurance in relation to exercise capacity and tolerance, providing a platform for behavioural advice particularly when exercise was promoted by the clinician.
Conclusions
Many of the practices that have been built up around the use of the exercise ECG are potentially beneficial to patients and need to be considered in the re-design of services without that test. Through its contribution to the patient's history and to subsequent advice to the patient, the exercise ECG continues to inform the specialist assessment and management of patients with new onset stable chest pain, beyond its now marginalised role in diagnosis.
Article summary
Article focus
Given the widespread use of the exercise ECG in assessments of patients with stable chest pain, this paper seeks to understand its role in the light of emerging evidence about its poor performance as a diagnostic test.
This paper reports on the functions of the exercise ECG in UK chest pain clinics, highlighting those uses that go beyond its diagnostic function.
This paper is part of an international debate about the appropriate initial tests for patients with new onset stable chest pain.
Key messages
The exercise ECG has additional functions that transcend its technical contribution to diagnosis: it can help clarify symptoms and other aspects of the clinical history, engage the patient in the diagnostic process, provide a context for guidance on reversible cardiovascular risk factors, be used to better involve and reassure patients and has the potential use for tailored lifestyle advice.
Through its contribution to the patient's history and to subsequent advice to the patient, the exercise ECG continues to inform the specialist assessment and management of patients with new onset stable chest pain, beyond its now marginalised role in diagnosis.
Many of the practices that have been built up around the use of the exercise ECG are potentially beneficial to patients. As chest pain clinic services are re-configured without the test, in line with UK national (National Institute for Health and Clinical Excellence (NICE)) guidance, these practices need to be integrated into new diagnostic pathways.
Strengths and limitations of this study
A strength of our study is its ethnographic design incorporating the observation of patient–clinician consultations and combining these data with interviews: we knew what participants did as well as said.
The fieldwork was undertaken at a key time just before the introduction of the UK's 2010 NICE guidelines and therefore provides an understanding of current practice that can inform their implementation.
A limitation of our study is that data were collected largely from two chest pain clinics, potentially limiting the transferability of the findings, although the clinicians in the research team thought that the clinics were not atypical compared to others they had experienced.
doi:10.1136/bmjopen-2011-000508
PMCID: PMC3277903  PMID: 22318662
6.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation 
Objective An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain.
Design Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial.
Participants 579 patients with chronic or recurrent low back pain recruited from primary care.
Interventions Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse.
Main outcome measures Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves.
Results Intervention costs ranged from £30 for exercise prescription to £596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from £50 for 24 lessons in Alexander technique to £124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value (£61 per point on disability score, £9 per additional pain-free day, £2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional £64 per point on disability score, £43 per additional pain-free day, £5332 per QALY gain).
Conclusions An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above £20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.
doi:10.1136/bmj.a2656
PMCID: PMC3272680  PMID: 19074232
7.  How persistent is ADHD? A controlled 10-year follow-up study of boys with ADHD 
Psychiatry research  2010;177(3):299-304.
The main aim of this study was to examine the age-dependent persistence of ADHD in boys transitioning from adolescence into early adulthood attending to different definitions of persistence. We conducted a 10-year follow-up study (mean follow-up time=11 years) of 110 boys with ADHD and 105 non-ADHD controls. Both groups were 6–17 years of age at ascertainment. ADHD was considered persistent at follow-up if subjects met full or subthreshold (more than half of the symptoms required for a full diagnosis) DSM-IV diagnostic criteria, failed to attain functional remission (GAF score ≤60), or were receiving treatment for ADHD. While 65% of children with ADHD no longer met full DSM-IV criteria for ADHD at the 10-year follow-up, 78% of subjects met at least one of our definitions of persistence. Persistence as described above was associated with more psychiatric comorbidity, more familiality with mood disorders, and higher levels of educational and interpersonal impairments than controls. This 10-year longitudinal follow-up study shows that the majority of ADHD boys experience persistent symptoms and functional impairments into early adulthood. Persistence of ADHD is associated with greater psychiatric comorbidity, familiality and functional impairments.
doi:10.1016/j.psychres.2009.12.010
PMCID: PMC2881837  PMID: 20452063
longitudinal; adult; remission; ADHD
8.  Decisions to use complementary and alternative medicine (CAM) by male cancer patients: information-seeking roles and types of evidence used 
Background
Complementary and Alternative Medicine (CAM) is increasingly popular with cancer patients and yet information provision or discussion about CAM by health professionals remains low. Previous research suggests that patients may fear clinicians' 'disapproval' if they raise the subject of CAM, and turn to other sources to acquire information about CAM. However, little empirical research has been conducted into how cancer patients acquire, and, more importantly evaluate CAM information before deciding which CAM therapies to try.
Methods
Qualitative study, comprising semi-structured interviews with 43 male cancer patients of varying ages, cancer type and stage of illness, 34 of whom had used CAM. They were recruited from a range of NHS and non-NHS settings in Bristol, England.
Results
As a result of the lack of CAM information from health professionals, men in this study became either 'pro-active seekers' or 'passive recipients' of such information. Their main information resource was the 'lay referral' network of family, friends and acquaintances, especially females. 'Traditional' information sources, including books, magazines, leaflets and the media were popular, more so in fact than the internet. Views on the internet ranged from enthusiasm or healthy scepticism through to caution or disinterest. CAM information was generally regarded as 'empowering' as it broadened treatment and self-care options. A minority of participants were information averse fearing additional choices that might disrupt their fragile ability to cope. There was general consensus that CAM information should be available via the NHS, to give it a 'stamp of approval', which combined with guidance from informed health professionals, could help patients to make 'guided' choices. However, a small minority of these men valued the independence of CAM from the NHS and deliberately sought 'alternative' information sources and treatment options.
Men were selective in identifying particular therapies to use and sceptical about others, basing their choices on forms of 'evidence' that were personally meaningful: personal stories of individuals who had been helped by CAM; the long history and enduring popularity of some therapies; the plausibility of the mechanism of action; a belief or trust in individual therapies or their providers; scientific evidence. Scientific evidence ranked low in the men's personal decision-making about CAM, while it was recognised as important for NHS support for CAM.
Conclusion
These male cancer patients valued the support and guidance of 'trusted individuals' in making choices about CAM. Trusted health professionals could also play a significant role in helping patients to make informed choices. Any such dialogue must, however, acknowledge the different standards of evidence used by patients and clinicians to evaluate the benefits or otherwise of CAM therapies. Such open communication could help to foster an environment of mutual trust where patients are encouraged to discuss their interest in CAM, rather than perpetuate covert, undisclosed use of CAM with its attendant potential hazards.
doi:10.1186/1472-6882-7-25
PMCID: PMC2000907  PMID: 17683580
9.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain 
Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain.
Design Factorial randomised trial.
Setting 64 general practices in England.
Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription.
Interventions Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling.
Main outcome measures Roland Morris disability score (number of activities impaired by pain) and number of days in pain.
Results Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported.
Conclusions One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.
Trial registration National Research Register N0028108728.
doi:10.1136/bmj.a884
PMCID: PMC3272681  PMID: 18713809

Results 1-9 (9)