RecruitingNot ApplicableNCT06365021

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


Sponsor

Beny Lafer

Enrollment

42 participants

Start Date

May 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether Acceptance and Commitment Therapy (ACT) — a form of talk therapy focused on managing difficult thoughts and feelings — delivered in group sessions can help people with bipolar disorder who are currently experiencing depressive symptoms. **You may be eligible if...** - You have been diagnosed with Bipolar Disorder Type I or II (based on DSM-5 criteria) - You are currently experiencing depressive symptoms (MADRS score above 12) - You are not currently in any other psychotherapy program - You are able to attend in-person group therapy sessions **You may NOT be eligible if...** - You have an organic brain disorder - You are currently experiencing manic or hypomanic symptoms (elevated or euphoric mood) - You are already in psychotherapy and cannot pause it during the study - Your medications changed significantly in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAcceptance and Commitment Therapy

The ACT protocol for this study was developed by ACT psychologist Tatiana Cohab Khafif specifically for this study and for Bipolar Patients. It is a 12-session protocol that combines psychoeducation elements, mindfulness exercises, experiential exercises, discussions and group processes, homework assignments, and flexible repertoire modeling and training. The protocol is designed to fit into a single trimester. It covers all the basic aspects of Bipolar Disorder and the six processes of ACT.

OTHERBipolar Disorder Psychoeducation Therapy

The psychoeducation protocol for this study was developed by clinical psychologist Tatiana Cohab Khafif specifically for this study and for Bipolar Patients. It is a 3-session protocol that combines psychoeducation elements, mindfulness exercises, and discussions regarding the main aspects and symptoms of BD. The protocol is designed to fit into a single month, and has a specifically brief format in order for it not to crossover with psychotherapy. It covers all the basic aspects of Bipolar Disorder.


Locations(1)

Tatiana Cohab Khafif

São Paulo, São Paulo, Brazil

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NCT06365021


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