TY - JOUR

T1 - Bi-real

T2 - A 12-session DBT skills group intervention adapted for bipolar disorder - A feasibility randomised pilot trial

AU - Azevedo, Julieta

AU - Swales, Michaela

AU - Carreiras, Diogo

AU - Guiomar, Raquel

AU - Macedo, António

AU - Castilho, Paula

N1 - Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.

PY - 2024/7/1

Y1 - 2024/7/1

N2 - UNLABELLED: 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.

AB - UNLABELLED: 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.

KW - Humans

KW - Bipolar Disorder/therapy

KW - Female

KW - Male

KW - Adult

KW - Pilot Projects

KW - Feasibility Studies

KW - Psychotherapy, Group/methods

KW - Middle Aged

KW - Dialectical Behavior Therapy/methods

KW - Quality of Life

KW - Treatment Outcome

U2 - 10.1016/j.jad.2024.04.033

DO - 10.1016/j.jad.2024.04.033

M3 - Article

C2 - 38615843

VL - 356

SP - 394

EP - 404

JO - Journal of Affective Disorders

JF - Journal of Affective Disorders

SN - 0165-0327

ER -