ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365021
• Other study ID #: 88887.687583/2022-00
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: University of Sao Paulo
• Contact: Beny Lafer, MD PhD
• Phone: +5511 999381849
• Email: Benylafer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 3 different time-points:

pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). 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. Psychological Flexibility scale will be assessed every week for the duration of treatment; as well as brief mood diary, which will be assessed daily for the duration of treatment.

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.

Description:

Bipolar disorder (BD) is a serious psychiatric disorder characterized by recurrent episodes of mania and depression. The treatment of BD includes a combination of pharmacological medications and psychotherapy to manage episodes and prevent recurrence.

Acceptance and Commitment Therapy (ACT) is an evidence-based psychotherapy. Although there is ample evidence for the efficacy of ACT in the treatment of psychiatric disorders, the literature on ACT for BD is still scarce.There are only five published studies, with three of them being pilot studies.

The present study is justified by the importance to fill a gap in the literature, by aiming to evaluate the effectiveness of ACT as a psychotherapeutic intervention for BD patients and to understand its possible effects mood, quality of life, functionality, sleep, and psychological flexibility on this population.

Main Objective:

To investigate the effectiveness of ACT, in improving syndromic and sub-syndromic depressive symptoms in patients with BD.

Specific objectives:

1. To investigate the efficacy of ACT for improving the quality of life in patients with BD.

2. To investigate the efficacy of ACT in improving functionality in patients with BD.

3. To investigate the efficacy of ACT in improving sleep quality in patients with BD.

4. To investigate the efficacy of ACT in improving psychological flexibility in patients with BD.

Material and Methods:

All participants will be recruited from patients regularly enrolled at the Bipolar Disorder Program - PROMAN - outpatient clinic at Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo. Participants will have access to the Informed Consent Form (ICF), and only those who agree to participate will be included in the study. Randomization Individuals with Bipolar Disorder recruited for the research will be randomized to the ACT arm or Usual Treatment arm through the Online Randomization software.

Procedures:

1. Recruitment will take place in the outpatient clinic of the Bipolar Disorder Program (PROMAN) of the HC-FMUSP Psychiatric Institute and online through the Hospital's social medias.

2. Interested individuals will undergo an initial screening to verify eligibility based on the selection criteria established in the study.

3. Individuals who meet the inclusion criteria will undergo a psychiatric evaluation based on the Standardized Structured Clinical Diagnostic Interview for DSM IV - Axis I Disorders (M.I.N.I.). and complete the initial phase (pre-treatment) instruments via the REDCap platform.

4. Included participants will be randomized into ACT or Psychoeducation group.

5. Participants will be contacted by email or text message with informations regarding the start of treatment.

6. Throughout the intervention, Mood scales (YMRS and MADRS), Psychological Flexibility Scale (PSY-FLEX) and a brief mood diary will be administered periodically (every two weeks, weekly and daily, respectively) to obtain Ecological Momentary Assessment (EMA) data from the participants.

7. At the end of the intervention, the same assessments administered at baseline will be repeated, as well as at the 6-month follow-up.

For control purposes, medication changes will be monitored using the MRTF Scale, which allows monitoring of the frequency, type, and reasons for changes in dosages and medications during the intervention protocol. Throughout the study, participants in both groups will continue to receive their usual pharmacological treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Bipolar Disorder type I and II according to DSM V

• Presence of depressive symptoms (MADRS>12)

• Not undergoing psychotherapy

• Availability to attend group therapy sessions

• Signing the TCLE

Exclusion Criteria:

• Organic mental disorder

• Presence of manic or hypomanic symptoms (YMRS>12)

• Currently undergoing psychotherapy

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.

Locations

Country	Name	City	State
Brazil	Tatiana Cohab Khafif	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Beny Lafer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Generalized Anxiety Disorder 7-item Scale	Minimum value: 0 (better) Maximum value: 21 (worse)	Baseline, post-treatment (week 12), and follow-up (week 24)
Other	Medication Recommendation Tracking Form	Tracks patient medication use and dosage. There is no score.	Baseline, post-treatment (week 12), and follow-up (week 24)
Other	Regulatory Satisfaction Alertness Timing Efficiency Duration	Minimum Value: 0 (worse) Maximum Value: 18 (better)	Baseline, post-treatment (week 12), and follow-up (week 24)
Other	Adhesion and Satisfaction Questionnaire	Minimum Value: 0 (worse) Maximum Value: 10 (better)	Baseline, post-treatment (week 12), and follow-up (week 24)
Other	Life Events Scale	Minimum Value: 14 (worse) Maximum Value: 70 (better)	Baseline, post-treatment (week 12), and follow-up (week 24)
Primary	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-up (week 24)
Primary	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-up (week 24)
Secondary	Functional Assessment Staging Tool	Minimum value: 0 (better) Maximum value: 72 (worse)	Baseline, post-treatment (week 12), and follow-up (week 24)
Secondary	World Health Organization Quality of Life Brief Scale	Minimum value: 0 (worse) Maximum value: 100 (better)	Baseline, post-treatment (week 12), and follow-up (week 24)
Secondary	Pittsburgh Sleep Quality Index	Minimum Value: 0 (better) Maximum Score: 21 (worse)	Baseline, post-treatment (week 12), and follow-up (week 24)
Secondary	Psychological Flexibility Questionnaire	Minimum value: 7 (worse) Maximum value: 49 (better) Higher scores mean a better outcome	Baseline, during treatment weekly, post-treatment (week 12), and follow-up (week 24)