Bipolar DisorderNCT06365021
ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder
A study testing Acceptance and Commitment Therapy and Bipolar Disorder Psychoeducation Therapy in people with Bipolar Disorder, run by Beny Lafer at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Acceptance and Commitment Therapy and Bipolar Disorder Psychoeducation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2024to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (IPq-HC-FMUSP)
São Paulo, São Paulo, 01231010
About this study
Official title: Acceptance and Commitment Therapy for Individuals With Syndromic and Subsyndromic Depression in Bipolar Mood Disorder: A Controlled and Randomized Clinical Trial
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
Read more
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.
Read the detailed 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 on mood, quality of life, functionality, sleep, and psychological flexibility in this population.
Main Objective:
To investigate the effectiveness of ACT in improving syndromic and sub-syndromic depressive symptoms in patients with BD.
Specific objectives:
- To investigate the efficacy of ACT for improving the quality of life in patients with BD.
- To investigate the efficacy of ACT in improving functionality in patients with BD.
- To investigate the efficacy of ACT in improving sleep quality in patients with BD.
- To investigate the efficacy of ACT in improving psychological flexibility in patients with BD.
Material and Methods:
Participants will be recruited from the Bipolar Disorder Program (PROMAN) outpatient clinic at Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, from psychiatrist referrals, and through the institute's social media. 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 the Brief Psychoeducation arm using block randomization in REDCap, with the allocation sequence generated by an independent biostatistician not otherwise involved in study procedures.
Procedures:
- Recruitment will take place in the outpatient clinic of the Bipolar Disorder Program (PROMAN) of the HC-FMUSP Institute of Psychiatry, through psychiatrist referrals, and online through the Hospital's social media.
- Interested individuals will undergo an initial screening to verify eligibility based on the selection criteria established in the study.
- Individuals who meet the inclusion criteria will undergo a psychiatric evaluation with the Mini International Neuropsychiatric Interview (M.I.N.I.) and complete the initial phase (pre-treatment) instruments via the REDCap platform.
- Included participants will be randomized into the ACT or Brief Psychoeducation group.
- Participants will be contacted by email or text message with information regarding the start of treatment.
- Throughout the intervention, mood scales (YMRS and MADRS) will be administered periodically (every two weeks).
- At the end of the intervention, the same assessments administered at baseline will be repeated, as well as at 6, 9 and 12-month follow-ups.
For control purposes, medication changes will be monitored using the Medication Recommendation Tracking Form (MRTF), 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.
- Conditions
- Bipolar Disorder
- Being tested
- Acceptance and Commitment Therapy, Bipolar Disorder Psychoeducation Therapy
- Keywords
- Acceptance and Commitment Therapy, Bipolar Disorder, Psychotherapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
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.
Bipolar Disorder Psychoeducation TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Bipolar Disorder Psychoeducation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Scale
Minimum value: 0 (better) Maximum value: 60 (worse)
Measured: 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: 60 (worse)
Measured: 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)
Functioning Assessment Short Test
Minimum value: 0 (better) Maximum value: 72 (worse)
Measured: Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
World Health Organization Quality of Life Brief Scale
Minimum value: 0 (worse) Maximum value: 100 (better)
Measured: Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
Pittsburgh Sleep Quality Index
Minimum Value: 0 (better) Maximum Score: 21 (worse)
Measured: Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
Psychological Flexibility Questionnaire
Minimum value: 7 (worse) Maximum value: 49 (better) Higher scores mean a better outcome
Measured: Baseline, during treatment weekly, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start6 May 2024
- Primary completion28 Oct 2025
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beny Lafer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beny Lafer, University of Sao Paulo
- Investigators
- Beny Lafer, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365021
- Sponsor's protocol ID
- 88887.687583/2022-00
- Status last verified
- Sep 2026
- First submitted
- 3 Apr 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, upon request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Individuals With Syndromic and Subsyndromic Depression in Bipolar Mood Disorder: A Controlled and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06365021
- Acronym / sponsor ID
- 88887.687583/2022-00
- Conditions
- Bipolar Disorder
- Keywords
- Acceptance and Commitment Therapy, Bipolar Disorder, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Beny LaferUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 on mood, quality of life, functionality, sleep, and psychological flexibility in this population.
Main Objective:
To investigate the effectiveness of ACT in improving syndromic and sub-syndromic depressive symptoms in patients with BD.
Specific objectives:
- To investigate the efficacy of ACT for improving the quality of life in patients with BD.
- To investigate the efficacy of ACT in improving functionality in patients with BD.
- To investigate the efficacy of ACT in improving sleep quality in patients with BD.
- To investigate the efficacy of ACT in improving psychological flexibility in patients with BD.
Material and Methods:
Participants will be recruited from the Bipolar Disorder Program (PROMAN) outpatient clinic at Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, from psychiatrist referrals, and through the institute's social media. 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 the Brief Psychoeducation arm using block randomization in REDCap, with the allocation sequence generated by an independent biostatistician not otherwise involved in study procedures.
Procedures:
- Recruitment will take place in the outpatient clinic of the Bipolar Disorder Program (PROMAN) of the HC-FMUSP Institute of Psychiatry, through psychiatrist referrals, and online through the Hospital's social media.
- Interested individuals will undergo an initial screening to verify eligibility based on the selection criteria established in the study.
- Individuals who meet the inclusion criteria will undergo a psychiatric evaluation with the Mini International Neuropsychiatric Interview (M.I.N.I.) and complete the initial phase (pre-treatment) instruments via the REDCap platform.
- Included participants will be randomized into the ACT or Brief Psychoeducation group.
- Participants will be contacted by email or text message with information regarding the start of treatment.
- Throughout the intervention, mood scales (YMRS and MADRS) will be administered periodically (every two weeks).
- At the end of the intervention, the same assessments administered at baseline will be repeated, as well as at 6, 9 and 12-month follow-ups.
For control purposes, medication changes will be monitored using the Medication Recommendation Tracking Form (MRTF), 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyParticipants 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. |
| Psychoeducation | Experimental | Other: Bipolar Disorder Psychoeducation TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTThe 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. | Behavioural | Acceptance and Commitment Therapy |
| Bipolar Disorder Psychoeducation TherapyThe 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. | Other | Psychoeducation |
Primary outcome
Montgomery-Asberg Depression Scale
Time frame: Baseline, during treatment every 2 weeks, post-treatment (week 12), in between assessments every 4 weeks, and follow-ups (6, 9 and 12 months)
Minimum value: 0 (better) Maximum value: 60 (worse)
Young Mania Rating Scale
Time frame: Baseline, during treatment every 2 weeks, post-treatment (week 12), in between assessments every 4 weeks, and follow-ups (6, 9 and 12 months)
Minimum value: 0 (better) Maximum value: 60 (worse)
4 secondary outcomes
Functioning Assessment Short Test
Time frame: Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
World Health Organization Quality of Life Brief Scale
Time frame: Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
Pittsburgh Sleep Quality Index
Time frame: Baseline, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
Psychological Flexibility Questionnaire
Time frame: Baseline, during treatment weekly, post-treatment (week 12), and follow-ups (6, 9 and 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. All collected IPD, upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beny Lafer, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy and Bipolar Disorder Psychoeducation Therapy in people with Bipolar Disorder, run by Beny Lafer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Scale (time frame: Baseline, during treatment every 2 weeks, post-treatment (week 12), in between assessments every 4 weeks, and follow-ups (6, 9 and 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.