Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-06 @ 10:13 PM
Study NCT ID:
NCT03191760
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-24', 'size': 824122, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-03T14:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist-Military Version', 'timeFrame': 'baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks', 'description': 'Change in PTSD symptoms'}, {'measure': 'Medical Outcomes Study Social Support Survey Form and Social Connectedness Scale - Revised', 'timeFrame': 'baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks', 'description': 'Change in social support'}, {'measure': 'Patient Health Questionnaire-9', 'timeFrame': 'baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks', 'description': 'Change in Depression symptoms'}, {'measure': 'Network Orientation Scale', 'timeFrame': 'baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks', 'description': 'Change in social network orientation'}, {'measure': 'Behavioral Activation for Depression Scale', 'timeFrame': 'baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks', 'description': 'Change in activity level'}], 'secondaryOutcomes': [{'measure': 'Qualitative assessment', 'timeFrame': '12 weeks', 'description': "Participants' reactions to the treatment will be gathered in qualitative interviews assessing treatment experience, perceptions of treatment focus, engagement with valued activities, social support, therapeutic relationship"}, {'measure': 'Additional treatment engagement', 'timeFrame': '16 weeks', 'description': 'measured via medical record review'}, {'measure': 'Brief COPE', 'timeFrame': 'baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks', 'description': 'Change in coping strategies'}, {'measure': 'Social Connectedness Scale - Revised (SCS-R)', 'timeFrame': 'baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks', 'description': "Change in the level of interpersonal closeness related to participants' social environment and the degree of difficulty experienced by participants in sustaining the sense of closeness"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Posttraumatic Stress Disorder', 'Social Support', 'Primary Care'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see if "Behavioral Activation and Social Engagement for PTSD" (BASE for PTSD), an individual therapy for PTSD, will help Veterans with PTSD 1) through improved understanding of how PTSD affects them, 2) by reducing ways in which they avoid meaningful activity due to PTSD, 3) by enabling them to do more of the things they really care about, and 4) by improving, strengthening, and building up their social supports.', 'detailedDescription': 'Posttraumatic stress disorder (PTSD) is a mental health condition that some people develop following exposure to a traumatic event. PTSD often results in a reduction in feelings of connection to other people and changes in views about others, as well as reduced participation in valued activities. Many veterans with PTSD do not seek treatment offered in specialty mental health settings and may forgo treatment of any kind.\n\nThis study is an open-trial format (no comparison condition) of U.S. military veterans who will participate in a brief psychotherapy treatment for PTSD offered in a Primary Care setting. This is a pilot trial to see if the treatment is effective at reducing symptoms of PTSD and increasing feelings of social support, and an exploratory aim is to see if veterans engage in additional treatment after completing this treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Veterans who:\n\n 1. are currently enrolled in either of the Primary Care Clinics (including Women's Clinic) or Primary Care Mental Health Integration clinic at VA Puget Sound Health Care System - Seattle Division\n 2. meet criteria for clinical or subclinical PTSD\n 3. are willing to have therapy sessions audiotaped for the purposes of supervision\n 4. plan to live in the Seattle area for 6 months following entry into the study\n\nExclusion Criteria:\n\n* Veterans who:\n\n 1. exhibit the presence of severe mental illness diagnosis (e.g., active psychosis and/or uncontrolled bipolar disorder)\n 2. have been a psychiatric in-patient admission in the past 30 days\n 3. have had a suicide attempt in the last 60 days\n 4. have had a plan or intent to harm self or others in the last 30 days\n 5. have a behavioral flag in their medical record\n 6. have had a psychiatric medication dosing or receipt that has changed in the last 30 days\n 7. are unwilling to provide at least 1 collateral contact\n 8. have impaired decision making capacity (as measured by evidence in the Computerized Patient Record System record of moderate-severe Traumatic Brain Injury, uncontrolled psychosis, dementia, communication flag, or by clinical judgment in speaking with the participant\n 9. are prisoners\n 10. are illiterate or have limited or no English proficiency\n 11. are terminally ill\n 12. are currently participating in Cognitive Processing Therapy (CPT) or Prolonged Exposure Therapy (PE)"}, 'identificationModule': {'nctId': 'NCT03191760', 'acronym': 'PTSD', 'briefTitle': 'Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)', 'organization': {'class': 'FED', 'fullName': 'VA Puget Sound Health Care System'}, 'officialTitle': 'Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': '00975'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Activation and Social Engagement', 'description': 'Participants will attend 6 in-person or phone-mediated therapy sessions lasting approximately 45 minutes per session, held in Primary Care settings. Content of therapy sessions includes education about PTSD symptoms, discussion of the role of avoidance in maintaining PTSD symptoms, self-monitoring homework to identify links between activity level and emotions, and homework designed to increase engagement in valued activities, with a focus on increasing social contact and support. If relevant, participants will be instructed in basic communication skills, social skills, and relaxation skills. We have modified the standard Behavioral Activation intervention by reducing the number and length of sessions to accommodate the Primary Care setting. In addition, there will be a stronger emphasis on social engagement in BASE then in standard BA and social contact and support will be addressed during each treatment session.', 'interventionNames': ['Behavioral: Behavioral Activation']}], 'interventions': [{'name': 'Behavioral Activation', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to attend 6 in-person or phone-mediated therapy sessions lasting approximately 45 minutes per session, to be held in Primary Care settings. Content of therapy sessions includes education about PTSD symptoms, discussion of the role of avoidance in maintaining PTSD symptoms, self-monitoring homework to identify links between activity level and emotions, and homework designed to increase engagement in valued activities, with a focus on increasing social contact and support. If relevant, participants will be instructed in basic communication skills, social skills, and relaxation skills.', 'armGroupLabels': ['Behavioral Activation and Social Engagement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98116', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Tracy Simpson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Scientist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Puget Sound Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician Investigator', 'investigatorFullName': 'Tracy Simpson', 'investigatorAffiliation': 'VA Puget Sound Health Care System'}}}}