Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 4:31 AM
Study NCT ID:
NCT06548893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance and Commitment Therapy (ACT) in Groups for Obsessive Compulsive Disorder: A Clinical Trial in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the team member who will apply the questionnaires/scales will be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yale-Brown Obsessive-Compulsive Scale (YBOCS)', 'timeFrame': '10 months (4-month intervention + 6-month follow-up)', 'description': 'Measure for assessing the presence and severity of obsessive-compulsive disorder (OCD) symptoms.'}], 'secondaryOutcomes': [{'measure': 'Acceptance and Commitment Therapy Processes (CompACT)', 'timeFrame': '10 months (4-month intervention + 6-month follow-up)', 'description': 'Measure of psychological flexibility'}, {'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-SV)', 'timeFrame': '10 months (4-month intervention + 6-month follow-up)', 'description': 'Measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of dally functioning'}, {'measure': 'Depression Anxiety and Stress Scale (DASS)', 'timeFrame': '10 months (4-month intervention + 6-month follow-up)', 'description': 'Set of self-report scales designed to measure the emotional states of depression, anxiety and stress.'}, {'measure': 'AAQ for Obsessions and Compulsions (AAQ-OC)', 'timeFrame': '10 months (4-month intervention + 6-month follow-up)', 'description': 'Self-report measure of experiential avoidance in response to unwanted intrusive thoughts.'}, {'measure': 'Affective Style Questionnaire (ASQ)', 'timeFrame': '10 months (4-month intervention + 6-month follow-up)', 'description': 'Brief instrument to measure individual differences in emotion regulation'}, {'measure': 'Clinical Global Impressions (CGI) Scale,', 'timeFrame': '10 months (4-month intervention + 6-month follow-up)', 'description': 'Quantify and track patient progress and treatment response over time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OCD', 'Obsessive-compulsive disorder'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '29966992', 'type': 'BACKGROUND', 'citation': 'Twohig MP, Abramowitz JS, Smith BM, Fabricant LE, Jacoby RJ, Morrison KL, Bluett EJ, Reuman L, Blakey SM, Ledermann T. Adding acceptance and commitment therapy to exposure and response prevention for obsessive-compulsive disorder: A randomized controlled trial. Behav Res Ther. 2018 Sep;108:1-9. doi: 10.1016/j.brat.2018.06.005. Epub 2018 Jun 22.'}], 'seeAlsoLinks': [{'url': 'https://www.utahact.com/treatment-protocols.html', 'label': 'ACT+ERP for OCD: This is a 16-session twice-weekly therapist manual for OCD describing ERP conducted from an ACT framework.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults.\n\nResearchers will compare intervention to control group to see if those who attend the group therapy have better results than control group.\n\nParticipants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).\n\n* Participants will not have any medication adjustment during therapy\n* Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.', 'detailedDescription': 'The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults. The main questions it aims to answer are:\n\n* Can ACT in groups help decrease the severity of OCD symptoms?\n* Can ACT in groups help increase psychological flexibility in this group?\n* Can ACT in groups help increase quality of life in this group?\n\nResearchers will compare intervention (n=16) to control group (n=8) to see if those who attend the group therapy have better results than control group.\n\nWe will perform an unequal randomization in a 2:1 ratio, in blocks of 6, for allocation to each group. The assessor of the outcomes of interest will be blinded to the group to which the participant was assigned\n\nParticipants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).\n\n* Participants will not have any medication adjustment during therapy\n* Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OCD diagnosis according to DMS-5/ Minimum score of 20 in YBOCS\n\nExclusion Criteria:\n\n* Psychotic disorder, maniac episode, intellectual disability, Chemical dependency, Suicidal risk, another current psychotherapy'}, 'identificationModule': {'nctId': 'NCT06548893', 'briefTitle': 'Acceptance and Commitment Therapy (ACT) in Groups for Obsessive Compulsive Disorder: A Clinical Trial in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Paraná'}, 'officialTitle': 'Group-based Acceptance and Commitment Therapy for Obsessive Compulsive Disorder: A Clinical Trial', 'orgStudyIdInfo': {'id': '61795622.3.0000.0096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group psychotherapy with ACT', 'description': '16 sessions of group psychotherapy based on ACT + exposure with response prevention (EPR)', 'interventionNames': ['Other: Group acceptance and commitment therapy (ACT)']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Patients will follow their usual treatment, without adding ACT-based group psychotherapy'}], 'interventions': [{'name': 'Group acceptance and commitment therapy (ACT)', 'type': 'OTHER', 'otherNames': ['Group Psychotherapy', 'Acceptance and Commitment Therapy', 'Psychotherapy'], 'description': 'Group psychotherapy based on ACT + EPR', 'armGroupLabels': ['Group psychotherapy with ACT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80060-900', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Universidade Federal Do Paraná', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}], 'overallOfficials': [{'name': 'Gabriela M Ferreira, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Paraná'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Paraná', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ms', 'investigatorFullName': 'Luciana Midori Samezima', 'investigatorAffiliation': 'Universidade Federal do Paraná'}}}}