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NCT06365021Recruiting

ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

Acceptance and Commitment Therapy for Individuals With Syndromic and Subsyndromic Depression in Bipolar Mood Disorder: A Controlled and Randomized Clinical Trial
Beny LaferClinicalTrials.govbehavioral
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
Acceptance and Commitment Therapy
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Beny Lafer
Funder
University of Sao Paulo
Location
São Paulo, Brazil
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Aug 01, 2026
Enrollment
42 participants
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
Bipolar affective disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06365021
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06365021 through Pure Global AI's free database. This phase not specified trial is sponsored by Beny Lafer and is currently Recruiting. The study focuses on Bipolar Disorder. Target enrollment is 42 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.