BI-REAL: A 12-session DBT skills group intervention adapted for bipolar disorder - A feasibility randomised pilot trial

Julieta Azevedo; Michaela Swales; Diogo Carreiras; Raquel Guiomar; António Macedo; Paula Castilho

doi:10.1016/j.jad.2024.04.033

BI-REAL: A 12-session DBT skills group intervention adapted for bipolar disorder - A feasibility randomised pilot trial

J Affect Disord. 2024 Jul 1:356:394-404. doi: 10.1016/j.jad.2024.04.033. Epub 2024 Apr 13.

Authors

Julieta Azevedo¹, Michaela Swales², Diogo Carreiras³, Raquel Guiomar³, António Macedo⁴, Paula Castilho³

Affiliations

¹ University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Portugal; Bangor University, School of Human and Behavioural Sciences, United Kingdom; Department of Psychology, University of Exeter, Exeter, UK. Electronic address: j.m.azevedo@exeter.ac.uk.
² Bangor University, School of Human and Behavioural Sciences, United Kingdom.
³ University of Coimbra, Faculty of Psychology and Educational Sciences, Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Portugal.
⁴ University of Coimbra, Faculty of Medicine, Institute of Psychological Medicine (IPM), Portugal; Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), Portugal; Centro Hospitalar e Universitário de Coimbra, EPE (CHUC), Coimbra, Portugal.

PMID: 38615843
DOI: 10.1016/j.jad.2024.04.033

Abstract

International guidelines endorse psychological treatment for Bipolar Disorder (BD); however, the absence of a recognised gold-standard intervention requires further research. A Dialectical Behaviour Therapy (DBT) skills group intervention with 12 sessions was developed. This pilot randomised controlled trial (RCT) aims to evaluate the feasibility, acceptability, and outcomes variance of Bi-REAL - Respond Effectively, Assertively, and Live mindfully, tailored for individuals with BD, in preparation for a future RCT.

Methods: 52 participants (female = 62.7 %; mean age = 43.2 ± 11.1) with BD were randomised by blocks to either the experimental group (EG; n = 26; Bi-REAL + Treatment as Usual, TAU) receiving 12 weekly 90-minutes sessions, or the control group (CG; n = 26, TAU). Feasibility and acceptability were assessed with a multimethod approach (qualitative interviews, semi-structured clinical interviews and a battery of self-report questionnaires - candidate main outcomes Bipolar Recovery Questionnaire (BRQ) and brief Quality of Life for Bipolar Disorder (QoL.BD)). All participants were evaluated at baseline (T0), post-intervention (T1) and 3-month follow-up (T2).

Results: Acceptability was supported by participants' positive feedback and ratings of the sessions and programme overall, as well as the treatment attendance (86.25 % of sessions attended). The trial overall retention rate was 74.5 %, with CG having a higher dropout rate across the 3-timepoints (42.31 %). A significant Time × Group interaction effect was found for BRQ and QoL.BD favouring the intervention group (p < .05).

Limitations: The assessors were not blind at T1 (only at T2). Recruitment plan was impacted due to COVID-19 restrictions and replication is questionable. High attrition rates in the CG.

Conclusions: The acceptability of Bi-REAL was sustained, and subsequent feasibility testing will be necessary to establish whether the retention rates of the overall trial improve and if feasibility is confirmed, before progressing to a definitive trial.

Keywords: Bipolar disorder; DBT-ST; Emotion regulation; Pilot RCT; Recovery; Skills training.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Bipolar Disorder* / therapy
Dialectical Behavior Therapy / methods
Feasibility Studies*
Female
Humans
Male
Middle Aged
Pilot Projects
Psychotherapy, Group* / methods
Quality of Life
Treatment Outcome