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Objectives: To evaluate the clinical effectiveness of group art therapy for people with schizophrenia and to test whether any benefits exceed those of an active control treatment., Design: Three arm, rater blinded, pragmatic, randomised controlled trial., Setting: Secondary care services across 15 sites in the United Kingdom., Participants: 417 people aged 18 or over, who had a diagnosis of schizophrenia and provided written informed consent to take part in the study., Interventions: Participants, stratified by site, were randomised to 12 months of weekly group art therapy plus standard care, 12 months of weekly activity groups plus standard care, or standard care alone. Art therapy and activity groups had up to eight members and lasted for 90 minutes. In art therapy, members were given access to a range of art materials and encouraged to use these to express themselves freely. Members of activity groups were offered various activities that did not involve use of art or craft materials and were encouraged to collectively select those they wanted to pursue., Main Outcome Measures: The primary outcomes were global functioning, measured using the global assessment of functioning scale, and mental health symptoms, measured using the positive and negative syndrome scale, 24 months after randomisation. Main secondary outcomes were levels of group attendance, social functioning, and satisfaction with care at 12 and 24 months., Results: 417 participants were assigned to either art therapy (n=140), activity groups (n=140), or standard care alone (n=137). Primary outcomes between the three study arms did not differ. The adjusted mean difference between art therapy and standard care at 24 months on the global assessment of functioning scale was -0.9 (95% confidence interval -3.8 to 2.1), and on the positive and negative syndrome scale was 0.7 (-3.1 to 4.6). Secondary outcomes did not differ between those referred to art therapy or those referred to standard care at 12 or 24 months., Conclusions: Referring people with established schizophrenia to group art therapy as delivered in this trial did not improve global functioning, mental health, or other health related outcomes., Trial Registration: Current Controlled Trials ISRCTN46150447.

Objective: To examine the effectiveness and cost-effectiveness of group therapy for self harm in young people., Design: Two arm, single (assessor) blinded parallel randomised allocation trial of a group therapy intervention in addition to routine care, compared with routine care alone. Randomisation was by minimisation controlling for baseline frequency of self harm, presence of conduct disorder, depressive disorder, and severity of psychosocial stress., Participants: Adolescents aged 12-17 years with at least two past episodes of self harm within the previous 12 months. Exclusion criteria were: not speaking English, low weight anorexia nervosa, acute psychosis, substantial learning difficulties (defined by need for specialist school), current containment in secure care. Setting Eight child and adolescent mental health services in the northwest UK., Interventions: Manual based developmental group therapy programme specifically designed for adolescents who harm themselves, with an acute phase over six weekly sessions followed by a booster phase of weekly groups as long as needed. Details of routine care were gathered from participating centres., Main Outcome Measures: Primary outcome was frequency of subsequent repeated episodes of self harm. Secondary outcomes were severity of subsequent self harm, mood disorder, suicidal ideation, and global functioning. Total costs of health, social care, education, and criminal justice sector services, plus family related costs and productivity losses, were recorded., Results: 183 adolescents were allocated to each arm (total n = 366). Loss to follow-up was low (<4%). On all outcomes the trial cohort as a whole showed significant improvement from baseline to follow-up. On the primary outcome of frequency of self harm, proportional odds ratio of group therapy versus routine care adjusting for relevant baseline variables was 0.99 (95% confidence interval 0.68 to 1.44, P = 0.95) at 6 months and 0.88 (0.59 to 1.33, P = 0.52) at 1 year. For severity of subsequent self harm the equivalent odds ratios were 0.81 (0.54 to 1.20, P = 0.29) at 6 months and 0.94 (0.63 to 1.40, P = 0.75) at 1 year. Total 1 year costs were higher in the group therapy arm (£21,781) than for routine care (£15,372) but the difference was not significant (95% CI -1416 to 10782, P = 0.132)., Conclusions: The addition of this targeted group therapy programme did not improve self harm outcomes for adolescents who repeatedly self harmed, nor was there evidence of cost effectiveness. The outcomes to end point for the cohort as a whole were better than current clinical expectations. Trial registration ISRCTN 20496110.

Objective: To determine whether a combination of a selective serotonin reuptake inhibitor (SSRIs) and cognitive behaviour therapy (CBT) together with clinical care is more effective in the short term than an SSRI and clinical care alone in adolescents with moderate to severe major depression., Design: Pragmatic randomised controlled superiority trial., Setting: 6 outpatient clinics in Manchester and Cambridge., Participants: 208 adolescents, aged 11-17, with moderate to severe major or probable major depression who had not responded to a brief initial intervention. Adolescents with suicidality, depressive psychosis, or conduct disorder were included., Interventions: 103 adolescents received an SSRI and routine care; 105 received an SSRI, routine care, and CBT. The trial lasted 12 weeks, followed by a 16 week maintenance phase., Main Outcome Measures: Change in score on the Health of the Nation outcome scales for children and adolescents (primary outcome) from baseline with 12 weeks as the primary and 28 weeks as the follow-up end point. Secondary measures were change in scores on the mood and feelings questionnaire, the revised children's depression rating scale, the children's global assessment scale, and the clinical global impression improvement scale., Results: At 12 weeks the treatment effect for the primary outcome was -0.64 (95% confidence interval -2.54 to 1.26, P=0.50). In a longitudinal analysis, there was no difference in effectiveness of treatment for the primary (average treatment effect 0.001, -1.52 to 1.52, P=0.99) or secondary outcome measures. On average there was a decrease in suicidal thoughts and self harm. There was no evidence of a protective effect of cognitive behaviour therapy on suicidal thinking or action. By 28 weeks, 57% were much or very much improved with 20% remaining unimproved., Conclusions: For adolescents with moderate to severe major depression there is no evidence that the combination of CBT plus an SSRI in the presence of routine clinical care contributes to an improved outcome by 28 weeks compared with the provision of routine clinical care plus an SSRI alone., Trial Registration: Current Controlled Trials ISRCNT 83809224.

Objective: To investigate the cost effectiveness of joint crisis plans, a form of advance agreement for people with severe mental illness., Design: Single blind randomised controlled trial., Setting: Eight community mental health teams in southern England., Participants: 160 people with a diagnosis of psychotic illness or non-psychotic bipolar disorder who had been admitted to hospital at least once within the previous two years., Intervention: Joint crisis plan formulated by the patient, care coordinator, psychiatrist, and project worker containing contact information, details of illnesses, treatments, relapse indicators, and advance statements of preferences for care for future relapses. Control group was standardised service information., Main Outcome Measures: Admission to hospital; service use over 15 months., Results: Use of a joint crisis plan was associated with less service use and lower costs on average than in the standardised service information group, but differences were not significant. Total costs during follow-up were 7264 pounds sterling (10,616 euros, 13,560 dollars) for each participant with a joint crisis plan and 8359 pounds sterling (12,217 euros, 15,609 dollars) for each participant with standardised service information (mean difference 1095 pounds sterling; 95% confidence interval -2814 to 5004). Cost effectiveness acceptability curves, used to explore uncertainty in estimates of costs and effects, suggest there is a greater than 78% probability that joint crisis plans are more cost effective than standardised service information in reducing the proportion of patients admitted to hospital., Conclusion: Joint crisis plans produced a non-significant decrease in admissions and total costs. Though the cost estimates had wide confidence intervals, the associated uncertainty suggests there is a relatively high probability of the plans being more cost effective than standardised service information for people with psychotic disorders.

Objective: To assess the feasibility of overcoming sample size limitations in economic analyses of clinical trials through meta-analysis of data on individual patients from multiple trials., Design: Meta-analysis of individual patient data from trials of counselling in primary care compared with usual care by a general practitioner., Setting: Primary care., Patients: People with mental health problems., Main Outcome Measures: Direct treatment costs, depressive symptoms, and cost effectiveness., Results: Meta-analysis of individual patient data proved feasible. The results showed that the previous analyses of individual trials were underpowered to provide useful conclusions about the cost comparisons. The results are sensitive to assumptions made about the costs of sessions with a counsellor and the management of patients by a general practitioner., Conclusions: Meta-analysis of individual patient data may assist in overcoming sample size limitations in economic analyses. Although feasible, such analysis has shortcomings that may limit the validity of the results. The relative costs and benefits of this method, as opposed to further collection of primary data, are as yet unclear.

Objective: To compare the cost effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients., Design: Prospective, controlled trial with randomised and patient preference allocation arms., Setting: General practices in London and greater Manchester., Participants: 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion., Interventions: Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists., Main Outcome Measures: Beck depression inventory scores, EuroQol measure of health related quality of life, direct treatment and non-treatment costs, and cost of lost production., Results: 197 patients were randomly assigned to treatment, 137 chose their treatment, and 130 were randomised only between the two psychological therapies. At four months, both non-directive counselling and cognitive-behaviour therapy reduced depressive symptoms to a significantly greater extent than usual general practitioner care. There was no significant difference in outcome between treatments at 12 months. There were no significant differences in direct costs, production losses, or societal costs between the three treatments at either four or 12 months. Sensitivity analyses did not suggest that the results depended on particular assumptions in the statistical analysis., Conclusions: Within the constraints of available power, the data suggest that both brief psychological therapies may be significantly more cost effective than usual care in the short term, as benefit was gained with no significant difference in cost. There are no significant differences between treatments in either outcomes or costs at 12 months.

Objective: To test the hypothesis that a community based intervention by secondary child and adolescent mental health services would be significantly more effective and less costly than a hospital based intervention., Design: Open study with two randomised parallel groups., Setting: Two health districts in the north of England., Participants: Parents of 3 to 10 year old children with behavioural disorder who had been referred to child and adolescent mental health services., Intervention: Parental education groups., Main Outcome Measures: Parents' and teachers' reports of the child's behaviour, parental depression, parental criticism of the child, impact of the child's behaviour on the family., Results: 141 subjects were randomised to community (n=72) or hospital (n=69) treatment. Primary outcome data were obtained on 115 (82%) cases a year later. Intention to treat analyses showed no significant differences between the community and hospital based groups on any of the outcome measures, or on costs. Parental depression was common and predicted the child's outcome., Conclusions: Location of child mental health services may be less important than the range of services that they provide, which should include effective treatment for parents' mental health problems.