ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder

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: 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: 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: 1. 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. 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 with the Mini International Neuropsychiatric Interview (M.I.N.I.) and complete the initial phase (pre-treatment) instruments via the REDCap platform. 4. Included participants will be randomized into the ACT or Brief Psychoeducation group. 5. Participants will be contacted by email or text message with information regarding the start of treatment. 6. Throughout the intervention, mood scales (YMRS and MADRS) will be administered periodically (every two weeks). 7. 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.