protocolSection identificationModule nctId: NCT06365021, orgStudyIdInfo id: 88887.687583/2022-00, briefTitle: ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beny Lafer, class: OTHER, descriptionModule briefSummary: 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 BDParticipants 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., conditionsModule conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance and Commitment Therapy, interventions name: Bipolar Disorder Psychoeducation Therapy, outcomesModule primaryOutcomes measure: Montgomery-Asberg Depression Scale, primaryOutcomes measure: Young Mania Rating Scale, secondaryOutcomes measure: Functional Assessment Staging Tool, secondaryOutcomes measure: World Health Organization Quality of Life Brief Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Psychological Flexibility Questionnaire, otherOutcomes measure: Generalized Anxiety Disorder 7-item Scale, otherOutcomes measure: Medication Recommendation Tracking Form, otherOutcomes measure: Regulatory Satisfaction Alertness Timing Efficiency Duration, otherOutcomes measure: Adhesion and Satisfaction Questionnaire, otherOutcomes measure: Life Events Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tatiana Cohab Khafif, status: RECRUITING, city: São Paulo, state: SP, zip: 01231010, country: Brazil, contacts name: Tatiana Khafif, Master's degree, role: CONTACT, phone: +5511983389643, email: taticohab@gmail.com, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False