Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365021
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-03
Brief Title:
ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder
Sponsor:
Beny Lafer
Organization:
University of Sao Paulo
Study Overview
Official Title:
Acceptance and Commitment Therapy for Individuals With Syndromic and Subsyndromic Depression in Bipolar Mood Disorder A Controlled and Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 scarceThere 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 Hospitals 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 MINI 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
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 scarceThere 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 Hospitals 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 MINI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None