Direct to Public Peer Support and e-Therapy Program Versus Information to Aid Self-Management of Depression and Anxiety: Protocol for a Randomized Controlled Trial.

BACKGROUND: Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymized public health-driven Web-based services such as Big White Wall (BWW), which offer immediate peer support at low cost. OBJECTIVE: Using Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) methodology, the aim of this study was to determine the population reach, effectiveness, cost-effectiveness, and barriers and drivers to implementation of BWW compared with Web-based information compiled by UK's National Health Service (NHS, NHS Choices Moodzone) in people with probable mild to moderate depression and anxiety disorder. METHODS: A pragmatic, parallel-group, single-blind randomized controlled trial (RCT) is being conducted using a fully automated trial website in which eligible participants are randomized to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, health care staff, large employers, and third sector groups. People will refer themselves to the study and will be eligible if they are older than 16 years, have probable mild to moderate depression or anxiety disorders, and have access to the Internet. RESULTS: The primary outcome will be the Warwick-Edinburgh Mental Well-Being Scale at 6 weeks. We will also explore the reach, maintenance, cost-effectiveness, and barriers and drivers to implementation and possible mechanisms of actions using a range of qualitative and quantitative methods. CONCLUSIONS: This will be the first fully digital trial of a direct to public online peer support program for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and RCT of two digital interventions using a fully automated digital enrollment and data collection process are considered for people with depression and anxiety. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 12673428; http://www.controlled-trials.com/ISRCTN12673428/12673428 (Archived by WebCite at http://www.webcitation.org/6uw6ZJk5a).

Cost-effectiveness of supported self-management for CFS/ME patients in primary care.

BACKGROUND: Nurse led self-help treatments for people with chronic fatigue syndrome/myalgic encephalitis (CFS/ME) have been shown to be effective in reducing fatigue but their cost-effectiveness is unknown. METHODS: Cost-effectiveness analysis conducted alongside a single blind randomised controlled trial comparing pragmatic rehabilitation (PR) and supportive listening (SL) delivered by primary care nurses, and treatment as usual (TAU) delivered by the general practitioner (GP) in North West England. A within trial analysis was conducted comparing the costs and quality adjusted life years (QALYs) measured within the time frame of the trial. 296 patients aged 18 and over with CFS/ME diagnosed using the Oxford criteria were included in the cost-effectiveness analysis. RESULTS: Treatment as usual is less expensive and leads to better patient outcomes compared with Supportive Listening. Treatment as usual is also less expensive than Pragmatic Rehabilitation. PR was effective at reducing fatigue in the short term, but the impact of the intervention on QALYs was uncertain. However, based on the results of this trial, PR is unlikely to be cost-effective in this patient population. CONCLUSIONS: This analysis does not support the introduction of SL. Any benefits generated by PR are unlikely to be of sufficient magnitude to warrant recommending PR for this patient group on cost-effectiveness grounds alone. However, dissatisfaction with current treatment options means simply continuing with 'treatment as usual' in primary care is unlikely to be acceptable to patients and practitioners. TRIAL REGISTRATION: The trial registration number is IRCTN74156610.

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder.

BACKGROUND: Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years), and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. METHODS/DESIGN: Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. DISCUSSION: The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement.

Role of road traffic accidents and other traumatic events in the onset of chronic widespread pain: Results from a population-based prospective study.

OBJECTIVE: To determine the relationship between physically traumatic events and the onset of chronic widespread pain (CWP). METHODS: This was a case-control study nested within a large prospective cohort. CWP was determined, by questionnaire, as per the American College of Rheumatology fibromyalgia classification criteria. Data were also collected on psychological health, health behavior, and sleep problems. Participants without CWP were then followed up at 4 years, and (new-onset) CWP was determined in the same manner. At followup, participants were also asked to report whether they had experienced any of a series of physically traumatic events between baseline and followup. RESULTS: A total of 2,069 individuals (46.6%) participated at followup, and 241 of these individuals (11.6%) reported CWP. More than one-third of the study population reported at least 1 physically traumatic event; although these individuals were more likely to develop CWP, this relationship was completely attenuated after adjustment for confounding (odds ratio 1.01, 95% confidence interval 0.73-1.40). However, there was some evidence to suggest that involvement in a road traffic accident, specifically, may confer an increase in the risk of CWP onset. CONCLUSION: This study provides support for the "at risk" phenotype hypothesis, where individuals characterized by poorer health and psychological variables may be predisposed to develop CWP following a traumatic trigger. However, although this has been seen with road traffic accidents, it is not the case with other events. Future research should examine what is peculiar about an accident, or about one's reaction to it, that confers this increase in the risk of CWP onset.

Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of home delivered pragmatic rehabilitation-a programme of gradually increasing activity designed collaboratively by the patient and the therapist-and supportive listening-an approach based on non-directive counselling-for patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis (CFS/ME). DESIGN: Single blind, randomised, controlled trial. SETTING: 186 general practices across the north west of England between February 2005 and May 2007. PARTICIPANTS: 296 patients aged 18 or over with CFS/ME (median illness duration seven years) diagnosed using the Oxford criteria. INTERVENTIONS: Participants were randomly allocated to pragmatic rehabilitation, supportive listening, or general practitioner treatment as usual. Both therapies were delivered at home in 10 sessions over 18 weeks by one of three adult specialty general nurses who had received four months' training, including supervised practice, in each of the interventions. GP treatment as usual was unconstrained except that patients were not to be referred for systematic psychological therapies during the treatment period. Main outcome measures The primary clinical outcomes were fatigue and physical functioning at the end of treatment (20 weeks) and 70 weeks from recruitment compared with GP treatment as usual. Lower fatigue scores and higher physical functioning scores denote better outcomes. RESULTS: A total of 257 (87%) of the 296 patients who entered the trial were assessed at 70 weeks, the primary outcome point. Analysis was on an intention to treat basis, with robust treatment effects estimated after adjustment for missing data using probability weights. Immediately after treatment (at 20 weeks), patients allocated to pragmatic rehabilitation (n=95) had significantly improved fatigue (effect estimate -1.18, 95% confidence interval -2.18 to -0.18; P=0.021) but not physical functioning (-0.18, 95% CI -5.88 to +5.52; P=0.950) compared with patients allocated to treatment as usual (n=100). At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435). At 20 weeks, patients allocated to supportive listening (n=101) had poorer physical functioning than those allocated to treatment as usual (-7.54, 95% CI -12.76 to -2.33; P=0.005) and no difference in fatigue. At 70 weeks, patients allocated to supportive listening did not differ significantly from those allocated to treatment as usual on either primary outcome. CONCLUSIONS: For patients with CFS/ME in primary care, pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual, but the effect is small and not statistically significant at one year follow-up. Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME. Trial registration International Standard Randomised Controlled Trial Number IRCTN74156610.

What characterizes persons who do not report musculoskeletal pain? Results from a 4-year Population-based longitudinal study (the Epifund study).

OBJECTIVE: To identify and characterize persons in the population who do not report musculoskeletal pain. METHODS: This was a population-based 4-year prospective longitudinal study by postal questionnaire. Population sample recruited from general practice registers in North-West England followed up at 15 months and 4 years. RESULTS: Of respondents, 17.4% [95% confidence interval (CI) 16.1%-19.7%] reported no pain in the previous month at all 3 measurement intervals over 4 years. They were characterized by low levels of psychological distress [relative risk (RR) low vs high levels of psychological distress 2.3; 95% CI 1.7-2.9], low levels of depression (2.7; 95% CI 2.0-3.6), low levels of anxiety (2.1; 95% CI 1.6-2.7), low health anxiety (1.6; 95% CI 1.2-2.1), and low illness behavior scores (5.8; 95% CI 4.0-8.3), good quality sleep (3.4; 95% CI 2.6-4.4), no somatic symptoms (RR 0 vs 3 or more, 3.1; 95% CI 1.6-6.3) and no adverse life events in the 6 months prior to baseline data collection (RR 0 vs 3 or more, 3.2; 95% CI 1.6-6.2). On multivariable analysis, good quality sleep, low illness behavior, low psychological distress, and absence of recent adverse life events remained statistically independent predictors of musculoskeletal health. In total, 46% of persons who had all 4 of these characteristics consistently reported being free of pain, compared to only 5% of those who had none. CONCLUSION: In a general population sample, over a period of 4 years, only around 1 in 6 persons do not report musculoskeletal pain. These persons report low levels of psychological distress and high quality sleep, both of which are potentially modifiable risk factors for the targeting of interventional or preventive strategies.

Adult attachment in bipolar 1 disorder.

OBJECTIVES: To determine how security of adult attachment style is related to the mania, major depression and euthymic mood states in bipolar 1 (BP1) disorder. DESIGN: An observational cross-sectional study. METHOD: One hundred and seven BP1 patients (34 in a manic type episode, 30 in major depressive episode, and 43 in remission) and 41 healthy controls similar in age, gender, reading age, and education were recruited. The groups were compared on self-reported mean and preferred attachment style controlling for psychiatric comorbidity. RESULTS: Preferred attachment style was insecure in 84 (78%) BP1 patients but only 13 (32%) healthy controls (chi(2)=34.3, df=3, and p<.001). Healthy controls reported higher secure attachment, lower anxious, and lower preoccupied attachment scores than all groups of patients with bipolar disorder, although the scores for secure attachment in mania and preoccupied attachment in euthymic patients were not significantly different from healthy controls. Overall, within the bipolar groups, anxious attachment style varied little with mood but mania was associated with higher secure and preoccupied attachment style, and depression with higher preoccupied and lower dismissing attachment style scores. CONCLUSIONS: Insecure attachment is found in most patients with BP1 disorder. Attachment style is affected by mood episodes so it should be assessed when a patient with bipolar disorder is in remission with minimal residual depressive or manic symptoms.

Enhanced relapse prevention for bipolar disorder: a qualitative investigation of value perceived for service users and care coordinators.

BACKGROUND: Enhanced relapse prevention (ERP) is a psychological intervention delivered by mental health professionals to help individuals with bipolar disorder (BD) recognise and manage early warning signs for mania and depression. ERP has an emerging evidence base and is recommended as good practice for mental health professionals. However, without highly perceived value to both those receiving (services users) or delivering it (health professionals), implementation will not occur. The aim of this study is to determine what values of ERP are perceived by service users (SUs) and mental health professionals (care coordinators, CCs) providing community case management. METHODS: A nested qualitative study design was employed as part of a randomised controlled trial of ERP. Semi-structured interviews were conducted with a purposive sub-sample of 21 CCs and 21 SUs, and an iterative approach used to develop a framework of conceptual categories that was applied systematically to the data. RESULTS: The process of implementing and receiving ERP was valued by both SUs and CCs for three similar sets of reasons: improved understanding of BD (where a knowledge deficit of BD was perceived), enhanced working relationships, and improved ways of managing the condition. There were some differences in the implications these had for both CCs and SUs who also held some reservations. CONCLUSION: CCs and SUs perceive similar value in early warning signs interventions to prevent relapse, and these have particular benefits to them. If this perceived value is maintained, CCs and SUs in routine practice may use ERP long-term.

General practitioners' views on reattribution for patients with medically unexplained symptoms: a questionnaire and qualitative study.

BACKGROUND: The successful introduction of new methods for managing medically unexplained symptoms in primary care is dependent to a large degree on the attitudes, experiences and expectations of practitioners. As part of an exploratory randomised controlled trial of reattribution training, we sought the views of participating practitioners on patients with medically unexplained symptoms, and on the value of and barriers to the implementation of reattribution in practice. METHODS: A nested attitudinal survey and qualitative study in sixteen primary care teams in north-west England. All practitioners participating in the trial (n = 74) were invited to complete a structured survey. Semi-structured interviews were undertaken with a purposive sub-sample of survey respondents, using a structured topic guide. Interview transcripts were used to identify key issues, concepts and themes, which were grouped to construct a conceptual framework: this framework was applied systematically to the data. RESULTS: Seventy (95%) of study participants responded to the survey. Survey respondents often found it stressful to work with patients with medically unexplained symptoms, though those who had received reattribution training were more optimistic about their ability to help them. Interview participants trained in reattribution (n = 12) reported that reattribution increased their confidence to practice in a difficult area, with heightened awareness, altered perceptions of these patients, improved opportunities for team-building and transferable skills. However general practitioners also reported potential barriers to the implementation of reattribution in routine clinical practice, at the level of the patient, the doctor, the consultation, diagnosis and the healthcare context. CONCLUSION: Reattribution training increases practitioners' sense of competence in managing patients with medically unexplained symptoms. However, barriers to its implementation are considerable, and frequently lie outside the control of a group of practitioners generally sympathetic to patients with medically unexplained symptoms and the purpose of reattribution. These findings add further to the evidence of the difficulty of implementing reattribution in routine general practice.

Enhanced relapse prevention for bipolar disorder--ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder.

BACKGROUND: Bipolar Disorder (BD) is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS) interventions in ways that will enhance dissemination. METHODS AND DESIGN: This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs) in community mental health teams (CMHTs) to offer Enhanced Relapse Prevention (ERP) to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU). The main aims of the study are (1) to determine the acceptability of the intervention, training and outcome measures (2) to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3) to estimate the design effect of clustering for key outcome variables (4) to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol. DISCUSSION: This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular cluster randomised controlled trials.

Treatment of patients with somatized mental disorder: effects of reattribution training on outcomes under the direct control of the family doctor.

Reattribution training is an 8-hour, skills-based training program delivered to family doctors so that they may better manage patients with somatized mental disorder. Separate consecutive cohorts of 103 and 112 patients with somatized mental disorder, respectively, visited eight family doctors before and after these physicians had undergone reattribution training. Reattribution training was associated with more frequent endorsement by patients after 1 month that they received the help they wanted and fewer beliefs by patients after 3 months that their symptoms had only a physical cause. Reattribution training did not change the incidence of investigations initiated by the family doctor, prescriptions for psychotropic or nonpsychotropic drugs, or referrals over 3 months.

Neuropsychological performance and noradrenaline function in chronic fatigue syndrome under conditions of high arousal.

RATIONALE: Subjective and objective impairments in neuropsychological function have been reported in chronic fatigue syndrome (CFS) patients under conditions of high arousal. These impairments may reflect impaired central noradrenaline function such as impaired post-synaptic alpha-2 adrenoceptor function. OBJECTIVES: To determine whether high-dose clonidine has greater agonist effects at central post-synaptic alpha-2 receptors in CFS patients than controls under conditions of high arousal. As a result clonidine may reverse neuropsychological deficits underlying symptoms of poor concentration and memory. METHODS: High-dose clonidine (2.5 mg/kg) and placebo challenge tests were given in random order to ten medication-free CFS patients without anxiety disorders, depressive disorders or migraine and ten matched healthy controls under the same stressors (timed neuropsychological testing, venous sampling, intravenous drug administration). Growth hormone, cortisol, blood pressure, pulse rate, visual analogue scales of subjective neuropsychological performance and the performance on several tests from a computerised neuropsychological battery were measured. RESULTS: In CFS patients versus controls, clonidine enhanced both growth hormone ( P = 0.028) and cortisol release ( P = 0.021) and increased speed in the initial stage of a planning task ( P = 0.023). There were no other differences between CFS patients and controls on hormonal, physiological, symptomatic or neuropsychological measures. CONCLUSIONS: Under conditions of high arousal, CFS patients may display supersensitive central post-synaptic alpha-2 adrenoceptor function associated with the release of cortisol and growth hormone and initial thinking time in planning tasks.