Life sciences · Interventional Study
ClinicalTrials.gov · October 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06365021). This is a study registration, not published results. Lead sponsor: Beny Lafer. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 75 participants (ACTUAL). Conditions: Bipolar Disorder. Interventions: BEHAVIORAL: Acceptance and Commitment Therapy; OTHER: Bipolar Disorder Psychoeducation Therapy. Primary outcome measures: Montgomery-Asberg Depression Scale , Baseline, during treatment every 2 weeks, post-treatment (week 12), in between assessments every 4 weeks, and follow-ups (6, 9 and 12 months); Young Mania Rating Scale , Baseline, during treatment every 2 weeks, post-treatment (week 12), in between assessments every 4 weeks, and follow-ups (6, 9 and 12 months). 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.