ABSTRACT FROM: Morriss R, Lobban F, Riste L, et al. 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. Lancet Psychiatry 2016;3:1029–38.
What is already known on this topic
Based in part on the resource heavy group psychoeducation delivered in Barcelona, the National Institute for Health and Care Excellence (NICE) argue that psychological interventions specifically developed for adults with bipolar disorder improve outcome, and therefore have made a developmental quality standard that patients with bipolar disorder should be offered psychological interventions.1 However, trials of more accessible interventions, for example, with fewer sessions or delivered by psychiatric nurses, have not shown such clear benefit.2 This research aims to determine whether pragmatic group psychoeducation reduces relapse risk in NHS (National Health Service) patients.
Methods of the study
Participants (n=304) were recruited from secondary and primary care and by self-referral, had a minimum age of 18 and a Structured Clinical Interview for DSM-IV (SCID) confirmed diagnosis of bipolar I or II and had experienced an episode within the past 24 months but not within the past 4 weeks. Current suicidal plans or high intent, and an inability to provide informed consent or to communicate sufficiently were exclusion factors. A multicentre randomised controlled trial was carried out comparing structured group psychoeducation plus treatment as usual (TAU) to unstructured peer support plus TAU. The psychoeducation consisted of 21 weekly 2-hour collaborative workshops which used a manual developed by the authors. The groups started with between 10 and 18 participants and were facilitated by two healthcare professionals and a service user. The primary outcome was time to next bipolar episode. This was determined using the SCID Longitudinal Interval Follow-up Evaluation. This was examined on an intention-to-treat basis visualised using Kaplan-Meier curves and analysed using the standard Cox model.
Participants were individually randomly assigned (1:1) using a computer-generated allocation sequence, stratified by clinical site and minimised by number of previous bipolar episodes. Research assistants blind to treatment allocation conducted all follow-up. Participants were followed for up to 96 weeks.
What this paper adds
Previous published bipolar psychoeducation groups in bipolar disorder have been facilitated solely by healthcare professionals. This study showed that such groups can be facilitated jointly by healthcare professionals working with service users.
Time to next bipolar episode did not differ between groups (HR 0.83, 95% CI 0.62 to 1.11).
After adjustment for prespecified covariates, there was weak evidence that time to mania-type episode was longer in participants in the psychoeducation group than in those in the peer-support group (HR 0.66, 95% CI 0.44 to 1.00).
Psychoeducation delayed time to next bipolar episode compared with peer support in participants with one to seven previous episodes (HR 0.28, 95% CI 0.12 to 0.68).
The initial psychoeducation studies were conducted in a tertiary care setting in Barcelona. This research shows that psychoeducation adapted and delivered by a UK team is effective in an NHS population.
Limitations
There was not a TAU only control group so any benefit over and above routine care could not be examined.
The primary outcome measure was time to next bipolar episode. This was examined using the SCID Longitudinal Interval Follow-up Evaluation every 16 weeks. This intermittent examination carries a risk that brief episodes may have been missed.
What next in research
The demonstrated efficacy in delaying mania in all patients suggests that the focus should be on delivery and on using implementation research with, for instance, normalisation process theory,3 to understand barriers and facilitators to the widespread delivery of group psychoeducation for patients with bipolar disorder in routine clinical settings in the NHS. This should be supported by economic analysis and by replication to confirm that this pragmatic intervention can be effectively delivered by other groups who start at a lower level of expertise.
The additional efficacy (delaying depression) in participants earlier in their illness histories suggests that implementation research should evaluate how this intervention should be particularly made available to patients who are at any earlier stage and also that modification is needed for those at a later stage to ameliorate the risk of depression.
Do these results change your practices and why?
Yes. These results show that manic relapse can be delayed in patients with bipolar disorder by this group intervention. Such psychological treatment is not part of my or other peoples’ routine practice but these results confirm that it should be. The challenge is to make psychoeducation part of the normal care pathway in bipolar disorder.
Footnotes
Competing interests: None declared.
Provenance and peer review: Commissioned; internally peer reviewed.
References
- 1. NICE. Bipolar disorder in adults; Quality standard [QS95] 2015.
- 2. Oud M, Mayo-Wilson E, Braidwood R, et al. Psychological interventions for adults with bipolar disorder: systematic review and meta-analysis. Br J Psychiatry 2016;208:213–22. 10.1192/bjp.bp.114.157123 [DOI] [PubMed] [Google Scholar]
- 3. May C, Finch T. Implementing, embedding, and integrating practices: an outline of normalization process theory. Sociology 2009;43:535–54. 10.1177/0038038509103208 [DOI] [Google Scholar]