ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder - Trial NCT06365021
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Study Focus
Sponsor & Location
Beny Lafer
University of Sao Paulo
Timeline & Enrollment
N/A
May 01, 2024
Aug 01, 2026
Primary Outcome
Montgomery-Asberg Depression Scale,Young Mania Rating Scale
Summary
The goal of this clinical trial is to test the efficacy of Acceptance and Commitment Therapy
 (ACT) as a psychotherapeutic treatment for patients with Bipolar Disorder (BD). The following
 questions will be investigated:
 
 - The efficacy of ACT in reducing depressive symptoms in patients with BD.
 
 - The efficacy of ACT in improving the quality of life in patients with BD.
 
 - The efficacy of ACT in improving functionality in patients with BD.
 
 - The efficacy of ACT in improving sleep quality in patients with BD.
 
 - The efficacy of ACT in improving psychological flexibility in patients with BD
 
 Participants in the clinical group will undergo 12, 2 hours, weekly sessions of Acceptance
 and Commitment Therapy, in addition to their regular pharmacological treatment.
 
 Participants in the control group will undergo 3, 2 hours, weekly sessions of Bipolar
 Disorder Psychoeducation Therapy, in addition to their regular pharmacological treatment.
 
 Scales and assessments will be used to measure study outcomes on 3 different time-points:
 pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). Mood scales
 will be assessed every 2 weeks for the duration of treatment and every 4 weeks during the
 additional 12 week follow-up period. Psychological Flexibility scale will be assessed every
 week for the duration of treatment; as well as brief mood diary, which will be assessed daily
 for the duration of treatment.
 
 Results will be compared among both groups to assess the effectiveness of Acceptance and
 Commitment Therapy as an intervention for syndromic and sub-syndromic depression in bipolar
 disorder.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06365021
Non-Device Trial