Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04667520
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of sample that is abstinent from alcohol', 'timeFrame': '12 months', 'description': 'Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed.'}], 'secondaryOutcomes': [{'measure': 'Alcohol-Related Consequences', 'timeFrame': '12 months', 'description': 'The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period.'}, {'measure': 'Depressive symptoms', 'timeFrame': '12 months', 'description': 'Symptoms of depression, as measured by the Patient Health Questionnaire-9'}, {'measure': 'Physical Activity levels', 'timeFrame': '12 months', 'description': 'Objectively measured steps/day with a Fitbit'}, {'measure': 'Alcohol Abstinence Self-Efficacy', 'timeFrame': '12 months', 'description': 'Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale'}, {'measure': 'Cardiorespiratory Fitness (estimated peak VO2)', 'timeFrame': '12 months', 'description': 'Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder', 'Depression']}, 'descriptionModule': {'briefSummary': 'The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments and EMA data will be collected.', 'detailedDescription': 'Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Women develop AUD more quickly and suffer a broader range of adverse alcohol-related health consequences than men. Physical activity (PA) interventions may play an important role as an alternate coping strategy for women with AUD and a means to decrease relapse.\n\nThe primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. A total of 214 women from the Alcohol and Drug Partial Hospitalization Program (ADP) at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments will occur at 6-weeks, end of treatment (EOT) at 3 months, and 6, 9 and 12 months. Participants will also complete 3, 10-day periods of ecological momentary assessment (EMA) during early recovery, at approximately weeks 1 \\& 2, 5 \\& 6, and again at weeks 11 \\& 12.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study enrolls females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* between 18 and 65 years of age\n* score of 5 or above on the PHQ-9 (need to have a score of 1 on questions 1 OR 2)\n* Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months)\n* are currently engaged in alcohol treatment\n* own a smartphone - to allow for EMA software and Fitbit application\n\nExclusion Criteria:\n\n* current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa\n* a history of psychotic disorder or current psychotic symptoms\n* current suicidality or homicidality\n* current mania\n* marked organic impairment according to either the medical record or responses to the diagnostic assessments\n* physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by study physician)\n* current pregnancy or intent to become pregnant during the next 12 weeks'}, 'identificationModule': {'nctId': 'NCT04667520', 'acronym': 'HEART', 'briefTitle': 'Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment', 'orgStudyIdInfo': {'id': '202006-001'}, 'secondaryIdInfos': [{'id': 'R01AA028186', 'link': 'https://reporter.nih.gov/quickSearch/R01AA028186', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LPA+Fitbit', 'description': 'Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data', 'interventionNames': ['Behavioral: Lifestyle Physical Activity (LPA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fitbit Only', 'description': 'Participants in this group are provided with a Fitbit to collect activity data', 'interventionNames': ['Behavioral: Fitbit Only']}], 'interventions': [{'name': 'Lifestyle Physical Activity (LPA)', 'type': 'BEHAVIORAL', 'description': 'This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation.', 'armGroupLabels': ['LPA+Fitbit']}, {'name': 'Fitbit Only', 'type': 'BEHAVIORAL', 'description': 'Participants are provided with a Fitbit during their study participation.', 'armGroupLabels': ['Fitbit Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana M Abrantes, Ph.D.', 'role': 'CONTACT', 'phone': '401-455-6440'}, {'name': 'Julie Desaulniers, M.S.', 'role': 'CONTACT', 'phone': '401-455-6219'}], 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Ana Abrantes, PhD', 'role': 'CONTACT', 'email': 'ana_abrantes@brown.edu', 'phone': '401-455-6652'}, {'name': 'Debra Herman, PhD', 'role': 'CONTACT', 'email': 'dherman@butler.org', 'phone': '401-455-6652'}], 'overallOfficials': [{'name': 'Ana Abrantes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}