Abstract
BackgroundCognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis. It is, however, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Acceptance and commitment therapy shows promise as a briefer, more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis. The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms.Methods/DesignThis is a single (rater)-blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition, Befriending. Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication. Following baseline assessment, participants are randomly allocated to treatment condition with blinded, post-treatment assessments conducted at the end of treatment and at 6 months follow-up. The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale. Secondary outcomes include preoccupation, conviction, distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales, as well as social functioning and service utilisation. The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required. The model of change underpinning ACT will be tested using mediation analyses.DiscussionThis protocol describes the first randomised controlled trial of Acceptance and commitment therapy in chronic medication-resistant psychosis with an active comparison condition. The rigor of the design will provide an important test of its action and efficacy in this population.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12608000210370. Date registered: 18 April 2008
Highlights
Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis
We considered that an eight-session intervention would provide a more comprehensive treatment for our chronically affected sample than that offered in the two trials with acute inpatients, but would remain much briefer than trials of CBT for Psychosis (CBTp), which average 20 sessions in length [35], and our combined ACT-Cognitive behavior therapy (CBT) Treatment of resistant command hallucinations (TORCH) protocol of 15 sessions [38]
This protocol describes the first Randomised controlled trial (RCT) of ACT in chronic medication-resistant psychosis. It is the first RCT of ACT in psychosis to use an active comparison group, and be designed to fully meet CONSORT criteria. It rises to the challenge of critics both of ACT trials, such as Öst [83], who point out the scarcity of well-controlled trials of the therapy across many client groups, and critics of CBTp trials who note variable trial quality [13,15] and the negative correlation between trial quality and strength of outcome [13,84]
Summary
Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis It is, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Whilst CBT for Psychosis (CBTp) includes a number of facets [1,2], the core intervention characterising this approach is belief modification (cognitive restructuring) – the ‘C’ in CBT [3] This involves modifying the content of anomalous beliefs identified as being associated with distress and dysfunction such as delusions and other symptom-related cognitions that may lead to distress, e.g. the belief that hallucinated voices have the power to harm the patient. Recent reviews have concluded that CBT has only a small effect on symptoms [14,15] and questioned its advantages over other less complex therapies [16,17], this has been vigorously debated (e.g., [18,19])
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