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

Abstract

BackgroundNon-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/designSingle 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.DiscussionThe 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.Trial RegistrationISRCTN62761948FundingNational Institute for Health Research, England.

Clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder (PARADES): a pragmatic, multicentre, observer-blind, randomised controlled superiority trial

“…The primary outcome measure was time to next bipolar episode (17,19) recorded by research assistants at each site. This was based on the SCID-LIFE (19,21), carried out every 16 weeks for 96 weeks.…”

“…We calculated time from randomisation to the first week of recurrence of an episode of mania, hypomania, a mixed episode, or major depression that lasted two consecutive weeks, satisfying DSM-IV criteria. When a follow up interview was not conducted, a bipolar episode was recorded when there was: (i) a description of symptoms of a manic or depression type episode, in primary or secondary care mental health records, with symptoms of sufficient duration to meet episode criteria (17,22) and (ii) there was a change of medication, care setting (inpatient or crisis team) or urgency of being reviewed because of these symptoms.…”

“…We recorded the type and amount of medication rather than medication adherence as a secondary outcome in our protocol (17). A nested qualitative study was conducted to explore the experiences of group participants and reasons for drop out from group treatment.…”

Cost-effectiveness of structured group psychoeducation versus unstructured group support for bipolar disorder: Results from a multi-centre pragmatic randomised controlled trial

“…Both treatments were delivered over a period of up to 26 weeks (allowing for holiday periods) (15). As part of PEd, a manual covering the 21 sessions was produced, with a session-specific handout for each session and opportunities for further 'homework tasks'.…”

“…The resources required to deliver the interventions were calculated based on their description as per the trial protocol (15). The amount of time dedicated to training and supervisions were recorded by the individuals who delivered the training and supervisions.…”