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Completed
NCT06365021
ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder
Conditions: Bipolar Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Beny Lafer
Location: Institute of Psychiatry, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (IPq-HC-FMUSP) São Paulo São Paulo
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
Source: ClinicalTrials.gov (NCT06365021). StuddyBuddy aggregates publicly available trial information.