NCT06365021 ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder
| NCT ID | NCT06365021 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beny Lafer |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2024-05-06 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Organic mental disorder * Presence of manic or hypomanic symptoms (YMRS\>12) * Currently undergoing psychotherapy (not able to pause during the study) * Major medication change in last 30 days
Contact & Investigator
Beny Lafer, MD PhD
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT06365021 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06365021 currently recruiting?
Yes, NCT06365021 is actively recruiting participants. Contact the research team at Benylafer@gmail.com for enrollment information.
Where is the NCT06365021 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06365021 clinical trial?
NCT06365021 is sponsored by Beny Lafer. The principal investigator is Beny Lafer, MD PhD at University of Sao Paulo. The trial plans to enroll 42 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.