Acceptance and Commitment Therapy for Individuals With Syndromic and Subsyndromic Depression in Bipolar Mood Disorder: A Controlled and Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Brazil
Tatiana Cohab Khafif
RECRUITING
São Paulo
Contact Information
Primary
Beny Lafer, MD PhD
Benylafer@gmail.com
+5511 999381849
Backup
Tatiana C Khafif, Master's degree
tatianakhafif@usp.br
+5511 98338-9643
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 42
Treatments
Experimental: Acceptance and Commitment Therapy
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.
Experimental: Psychoeducation
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.
Related Therapeutic Areas
Sponsors
Leads: Beny Lafer

This content was sourced from clinicaltrials.gov