ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

NCT06365021 | Completed

• 1 other identifier: 88887.687583/2022-00
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Acceptance and Commitment Therapy; Bipolar Disorder; Psychotherapy

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Scale

  Minimum value: 0 (better) Maximum value: 60 (worse)

  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

  Minimum value: 0 (better) Maximum value: 54 (worse)

  Baseline, during treatment every 2 weeks, post-treatment (week 12), in between assessments every 4 weeks, and follow-ups (6, 9 and 12 months)

Secondary Outcomes (4)

• Functional Assessment Staging Tool

  Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)

• World Health Organization Quality of Life Brief Scale

  Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)

• Pittsburgh Sleep Quality Index

  Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)

• Psychological Flexibility Questionnaire

  Baseline, during treatment weekly, post-treatment (week 12), and follow-ups (6, 9 and 12 months)

Other Outcomes (3)

• Generalized Anxiety Disorder 7-item Scale

  Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)

• Medication Recommendation Tracking Form

  Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)

• Regulatory Satisfaction Alertness Timing Efficiency Duration

  Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Participants in the clinical group will receive usual pharmacological treatment and undergo a protocol of 12 Acceptance and Commitment Therapy sessions, in group format, during 3 months. The intervention will be held weekly, with an estimated duration of 2 hours for each session, in addition to the participants' regular drug treatment. Scales are administered at the beginning and end of treatment, with follow-ups after 6, 9 and 12 months.

Behavioral: Acceptance and Commitment Therapy

Psychoeducation

EXPERIMENTAL

Participants in the control group will usual pharmacological treatment and 3 sessions of Psychoeducation, in group format. Scales are administered at the beginning and end of treatment, with follow-ups after 6, 9 and 12 months.

Other: Bipolar Disorder Psychoeducation Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Also known as: ACT

Acceptance and Commitment Therapy

Bipolar Disorder Psychoeducation Therapy OTHER

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beny Lafer: lead

Study Sites (1)

Tatiana Cohab Khafif

São Paulo, São Paulo, 01231010, Brazil

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Beny Lafer, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 15, 2024
• Study Start: May 6, 2024
• Primary Completion: October 28, 2025
• Study Completion: July 25, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after primary analysis is complete and published, end date undefined (unending)
• Access Criteria: other researchers conducting research on ACT and psychiatry or on bipolar disorder and psychotherapy

Locations

BR (1)