Actively Recruiting
Acceptance and Commitment Therapy for Individuals With Syndromic and Subsyndromic Depression in Bipolar Mood Disorder: A Controlled and Randomized Clinical Trial
Led by Beny Lafer · Updated on 2025-04-03
42
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Acceptance and Commitment Therapy (ACT) as a psychotherapeutic treatment for adults with Bipolar Disorder who have depressive symptoms. The study aims to assess ACT's effects on reducing depression, improving quality of life, functionality, sleep quality, and psychological flexibility in this population. This trial addresses a gap in research on ACT for Bipolar Disorder, comparing it with Psychoeducation Therapy alongside usual pharmacological treatments. Participants will be randomly assigned to one of two groups. The clinical group will receive 12 weekly group sessions of ACT, each lasting about 2 hours, over three months, in addition to their regular medication. The control group will receive 3 weekly group sessions of Psychoeducation Therapy, also alongside their usual drug treatment. Both therapies are tailored specifically for Bipolar Disorder and cover its main aspects. Participants will undergo mood assessments every two weeks during treatment and every four weeks during a 12-week follow-up. Other outcomes like quality of life, functionality, sleep, and psychological flexibility will be measured at the start, end of treatment, and at 6, 9, and 12 months follow-up. Medication changes will be monitored throughout. The total participation duration spans over a year, with evaluations to compare the effectiveness of ACT against Psychoeducation.
CONDITIONS
Brief Title
ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Bipolar Disorder type I or II according to DSM V
- Presence of depressive symptoms with MADRS score greater than 12
- Not currently undergoing psychotherapy
- Ability to attend in-person group therapy sessions
- Signing the informed consent form
You will not qualify if you...
- Having an organic mental disorder
- Presence of manic or hypomanic symptoms with YMRS score greater than 12
- Currently undergoing psychotherapy and unable to pause during the study
- Major medication change in the last 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial screening and psychiatric evaluation
Duration - 1 to 3 months depending on assigned therapy
Participants undergo either 12 weekly Acceptance and Commitment Therapy sessions over 3 months or 3 Psychoeducation sessions within 1 month, while continuing their usual pharmacological treatment.
Weekly visits for ACT group and 3 group sessions for Psychoeducation group
Duration - Up to 12 months after treatment completion
After treatment ends, participants are followed up with assessments at 6, 9, and 12 months to monitor mood, quality of life, functionality, sleep, and psychological flexibility.
3 follow-up visits at 6, 9, and 12 months
Trial Site Locations
Total: 1 location
1
Tatiana Cohab Khafif
São Paulo, São Paulo, Brazil, 01231010
Actively Recruiting
Research Team
B
Beny Lafer, MD PhD
T
Tatiana C Khafif, Master's degree
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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