ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

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.

Conditions

• Bipolar Disorder

Interventions

BEHAVIORAL

Acceptance 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.

OTHER

Bipolar 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.

Sponsors & Collaborators

• Beny Lafer

  lead OTHER

Principal Investigators

• Beny Lafer, MD PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-06

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Brazil

Study Locations