Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06365021

ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

Led by Beny Lafer · Updated on 2025-04-03

42

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Bipolar Disorder type I or II according to DSM V
  • Presence of depressive symptoms with MADRS score greater than 12
  • Not currently undergoing psychotherapy
  • Availability to attend in-person group therapy sessions
  • Signing consent form
Not Eligible

You will not qualify if you...

  • Organic mental disorder
  • Presence of manic or hypomanic symptoms with YMRS score greater than 12
  • Currently undergoing psychotherapy that cannot be paused during the study
  • Major medication change in the last 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Tatiana Cohab Khafif

São Paulo, São Paulo, Brazil, 01231010

Actively Recruiting

Loading map...

Research Team

B

Beny Lafer, MD PhD

CONTACT

T

Tatiana C Khafif, Master's degree

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here