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- Title
The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study): study protocol for a randomized controlled trial.
- Authors
Waller, Helen; Craig, Tom; Landau, Sabine; Fornells-Ambrojo, Miriam; Hassanali, Nedah; Iredale, Catherine; Jolley, Suzanne; McCrone, Paul; Garety, Philippa
- Abstract
<bold>Background: </bold>NICE guidance states that cognitive behavioural therapy (CBT) should be offered to all patients with psychosis. However, there is a need to improve access to therapeutic interventions. We aim to train frontline mental health staff to deliver brief, structured CBT-based therapies. We have developed and piloted a manualized intervention to support people with psychosis and anxious avoidance or depression to work towards a personal recovery goal.<bold>Methods/design: </bold>The 'GOALS Study' is a pilot randomized controlled trial comparing usual care plus an 8-week intervention with usual care alone. The key objective is to assess clinical feasibility (recruitment and randomization; compliance with the treatment manual; acceptability and satisfaction; progress towards goals). A secondary objective is a preliminary evaluation of efficacy. Sixty-six participants with a diagnosis of psychosis, plus symptoms of depression or anxiety will be recruited from adult mental health services. Those currently refusing medication, in receipt of CBT, or with a primary diagnosis of an organic mental health problem or substance dependency will be excluded. Following informed consent, randomization will be independent of the trial team, at a 50:50 ratio, at the level of the individual and stratified by main problem focus. Following randomization, participants allocated to the intervention group will begin the 8-week intervention with a local, trained member of staff, supervised by the study coordinator. Outcomes will be assessed blind to treatment condition at 0, 12 and 18 weeks post-randomization. The primary outcome measure for the efficacy analysis will be activity levels at 12 weeks. Secondary outcome measures include mood, psychotic symptoms, quality of life and clinical distress. A health economic analysis comparing service use in each condition will also be performed. Recruitment began in March, 2013 and is ongoing until December, 2014.<bold>Discussion: </bold>This is the first trial of the GOALS intervention. The approach is brief and staff can be readily trained in its delivery: there is therefore potential to develop a cost-effective intervention that could be widely disseminated. If the trial proves clinically feasible and demonstrates preliminary evidence of efficacy, a large multi-site trial will be warranted.<bold>Trial Registration: </bold>Current Controlled Trials<bold>Isrctn: </bold>73188383. http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13538.
- Publication
Trials, 2014, Vol 15, Issue 1, p255
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/1745-6215-15-255