NCT06365021Completed
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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 5 different time-points: pre-intervention (month 0), post-intervention (month 3), follow-up 1 (month 6), follow-up 2 (month 9), follow-up 3 (month 12). 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. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 3 Apr 2024
- Start date
- 6 May 2024
- Primary completion date
- 28 Oct 2025
- Lead sponsor
- Beny Lafer
- Diseases
- Bipolar disorder
- NCT number
- NCT06365021
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From 6 May 2024 to the primary completion date, 28 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major medication change in last 30 days
Other illness
- Organic mental disorder
Other
- Presence of manic or hypomanic symptoms (YMRS\>=12)
- Currently undergoing psychotherapy (not able to pause during the study)
Who the study is looking for
- Diagnosis of Bipolar Disorder type I and II according to DSM V
- Presence of depressive symptoms (MADRS\>=12)
- Not undergoing psychotherapy
- Availability to attend in-person group therapy sessions
- Signing consent form
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Psychiatry, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (IPq-HC-FMUSP) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.