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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:
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.
Full 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:
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:
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.
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42 participants in 2 patient groups
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Beny Lafer, MD PhD; Tatiana C Khafif, Master's degree
Data sourced from clinicaltrials.gov
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