Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-29 @ 2:06 AM
Study NCT ID:
NCT02499406
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2015-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dialectical Behavior Therapy Skills Group Pilot Evaluation
Sponsor:
Organization:
Raw JSON
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Lower score indicates fewer difficulties regulating emotions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants started the study; 15 provided data on this measure at 3months.'}, {'type': 'SECONDARY', 'title': 'Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Skills Group', 'description': 'Dialectical behavior therapy skills group\n\nDialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness'}], 'classes': [{'categories': [{'measurements': [{'value': '86.27', 'spread': '12.81', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.016', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for significance adjusted to p = .016 for multiple comparisons', 'groupDescription': 'Null hypothesis is no difference between baseline and this 6-month assessment.', 'statisticalMethod': 'paired samples t test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df=10'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Scale title: Difficulties in Emotion Regulation Scale (DERS). 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Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 participants started the study; 12 contributed data on this measure at 9months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Skills Group', 'description': 'Dialectical behavior therapy skills group\n\nDialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'missed 3 treatment sessions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Skills Group', 'description': 'Dialectical behavior therapy skills group\n\nDialectical behavior therapy skills group: Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '11.94', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-04', 'size': 254457, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-11T16:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2015-06-01', 'resultsFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-10', 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended)', 'timeFrame': '6 months', 'description': 'Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended)'}], 'secondaryOutcomes': [{'measure': 'Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention', 'timeFrame': '3 months', 'description': 'Acceptability to participants on the "Client Satisfaction Scale" created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint.'}, {'measure': 'Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention', 'timeFrame': '6 months', 'description': 'Acceptability to participants on the "Client Satisfaction Scale" created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint.'}, {'measure': 'Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up', 'timeFrame': '9 months', 'description': 'Acceptability to participants on the "Client Satisfaction Scale" created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint.'}, {'measure': 'Suicidal Ideation on Suicidal Behavior Questionnaire at 3months', 'timeFrame': '3 months', 'description': 'Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.'}, {'measure': 'Suicidal Ideation on Suicidal Behavior Questionnaire at 6months', 'timeFrame': '6 months', 'description': 'Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.'}, {'measure': 'Suicidal Ideation on Suicidal Behavior Questionnaire at 9months', 'timeFrame': '9 months', 'description': 'Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.'}, {'measure': 'Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months', 'timeFrame': '3 months', 'description': 'Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.'}, {'measure': 'Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention)', 'timeFrame': '6 months', 'description': 'Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.'}, {'measure': 'Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months', 'timeFrame': '9 months', 'description': 'Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.'}, {'measure': 'Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months', 'timeFrame': '3 months', 'description': 'Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.'}, {'measure': 'Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months', 'timeFrame': '6 months', 'description': 'Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.'}, {'measure': 'Coping as Assessed With the DBT Ways of Coping Checklist at 9months', 'timeFrame': '9 months', 'description': 'Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Suicidal Ideation', 'Emotions']}, 'descriptionModule': {'briefSummary': 'Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation.', 'detailedDescription': 'Uncontrolled pilot study to examine feasibility, acceptability, and preliminary efficacy of Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion dysregulation. Outcome measures will occur at pre-treatment, mid, end, and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Veterans at VACHS who are referred or self-referred to DBT Skills Group\n2. Ages 18-65\n3. Able to understand written and spoken English\n4. DERS score 105 or greater\n5. Suicidal ideation within past 3 months\n6. Seeing an individual mental health provider at VACHS at least monthly\n7. Willing to create or review a Mental Health Safety Plan, and stated willingness to use this plan to maintain safety\n8. Consent to participate in study assessments\n9. Consent to recording of group sessions\n\nExclusion Criteria:\n\n1. Inability to understand written or spoken English\n2. Diagnosis of schizophrenia, schizoaffective disorder, bipolar I, antisocial personality disorder, or thought disorder in CPRS problem list and confirmed by current mental health provider'}, 'identificationModule': {'nctId': 'NCT02499406', 'briefTitle': 'Dialectical Behavior Therapy Skills Group Pilot Evaluation', 'organization': {'class': 'FED', 'fullName': 'VA Connecticut Healthcare System'}, 'officialTitle': 'Dialectical Behavior Therapy Skills Group Pilot Evaluation', 'orgStudyIdInfo': {'id': 'VACHS HSS 01883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Skills group', 'description': 'Dialectical behavior therapy skills group', 'interventionNames': ['Behavioral: Dialectical behavior therapy skills group']}], 'interventions': [{'name': 'Dialectical behavior therapy skills group', 'type': 'BEHAVIORAL', 'description': 'Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness', 'armGroupLabels': ['Skills group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Health Care System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Suzanne Decker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Health Care System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}