Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT03363750
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Children's Depression Inventory-2 (CDI-2) scores", 'timeFrame': 'from baseline to within one month after end of intervention', 'description': 'self report long version (28 items) to assess the presence and severity of depressive symptoms in children'}, {'measure': "Change in Children's Depression Inventory-2 (CDI-2) scores", 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': 'self report long version (28 items) to assess the presence and severity of depressive symptoms in children'}], 'secondaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9) score', 'timeFrame': 'from baseline to within one month after end of intervention', 'description': 'self report (9 questions) to screen for the presence and severity of depression'}, {'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9) score', 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': 'self report (9 questions) to screen for the presence and severity of depression'}, {'measure': "Change in Rumination Subscale of the Children's Response Style Questionnaire Score", 'timeFrame': 'from baseline to within one month after end of intervention', 'description': 'self report (13 questions) of rumination symptoms'}, {'measure': "Change in Rumination Subscale of the Children's Response Style Questionnaire Score", 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': 'self report (13 questions) of rumination symptoms'}, {'measure': 'Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score', 'timeFrame': 'from baseline to within one month after end of intervention', 'description': 'self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present'}, {'measure': 'Change in Mindful Attention Awareness Scale-Adolescent (MAAS) score', 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': 'self report (14 questions) designed to assess open or receptive awareness of and attention to what is taking place in the present'}, {'measure': 'Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score', 'timeFrame': 'from baseline to within one month after end of intervention', 'description': 'self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms'}, {'measure': 'Change in Self-Efficacy Questionnaire for Depression in Adolescents (SEQ-DA) score', 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': 'self report (12 items) designed to measure self-perceived ability to cope with depressive symptoms'}, {'measure': 'Change in Suicide Ideation Questionnaire (SIQ) score', 'timeFrame': 'from baseline to within one month after end of intervention', 'description': 'self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation'}, {'measure': 'Change in Suicide Ideation Questionnaire (SIQ) score', 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': 'self report (30 or 15 items depending on grade level) to assess frequency of suicidal ideation'}, {'measure': 'Acceptability Questionnaire', 'timeFrame': 'within one month after end of intervention', 'description': 'self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention'}, {'measure': 'Acceptability Questionnaire', 'timeFrame': 'approximately 3 months after end of intervention', 'description': 'self report (15 items) intervention acceptability assessment of usefulness and helpfulness of the intervention'}, {'measure': 'Acceptability Questionnaire - open-ended questions for qualitative analyses', 'timeFrame': 'within one month after end of intervention', 'description': '3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention'}, {'measure': 'Acceptability Questionnaire - open-ended questions for qualitative analyses', 'timeFrame': 'approximately 3 months after end of intervention', 'description': '3 open-ended questions to gather qualitative data about the usefulness and helpfulness of the intervention'}, {'measure': 'Change in Hope Scale Score', 'timeFrame': 'from baseline to within one month after end of intervention', 'description': '* self report (12 items), 4-point Likert scale(1=Definitely False to 4=Definitely True)\n* evaluates global hope (range 8-32); there are also 2 subscales: hope agency (range 4-16) and hope pathways (range 4-16)\n* includes distracter items\n* global hope score calculated by summing the hope agency and hope pathways scores (omitting distracter items)\n* higher scores indicate a person has higher hope'}, {'measure': 'Change in Hope Scale Score', 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': '* self report (12 items), 4-point Likert scale(1=Definitely False to 4=Definitely True)\n* evaluates global hope (range 8-32); there are also 2 subscales: hope agency (range 4-16) and hope pathways (range 4-16)\n* includes distracter items\n* global hope score calculated by summing the hope agency and hope pathways scores (omitting distracter items)\n* higher scores indicate a person has higher hope'}, {'measure': 'Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score', 'timeFrame': 'from baseline to within one month after end of intervention', 'description': '* self report (14 items) to measure positive affect, satisfying interpersonal relationships, and positive functioning\n* 5-point Likert scale (1=none of the time to 5=all of the time)\n* total score is calculated by summing each item score (range 14-70)\n* higher scores represent increased levels of mental wellbeing'}, {'measure': 'Change in Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Score', 'timeFrame': 'from baseline to approximately 3 months after end of intervention', 'description': '* self report (14 items) to measure positive affect, satisfying interpersonal relationships, and positive functioning (range 14-70)\n* 5-point Likert scale (1=none of the time to 5=all of the time)\n* total score is calculated by summing each item score (range 14-70)\n* higher scores represent increased levels of mental wellbeing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Adolescent', 'mind-body-skills', 'group therapy', 'primary care'], 'conditions': ['Depression', 'Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '34706710', 'type': 'DERIVED', 'citation': 'Cunningham LD, Salgado EF, Aalsma MC, Garabrant JM, Staples JK, Gordon JS, Salyers MP. Do adolescents consider mind-body skills groups an acceptable treatment for depression: results from a pilot study. BMC Pediatr. 2021 Oct 27;21(1):475. doi: 10.1186/s12887-021-02942-3.'}]}, 'descriptionModule': {'briefSummary': 'The Center for Mind -Body Medicine has developed a mind-body skills group program that incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement. These mind-body skills are designed to increase self-awareness and self-regulation. This program has been shown to significantly improve depression symptoms in children and adolescents with posttraumatic stress disorder in Gaza, but it has not yet been tested in a US adolescent population. The purpose of this study is to determine the feasibility of using mind-body skills groups to reduce depression in adolescents and to investigate the effects of the program on factors such as self-efficacy, mindfulness and rumination which are likely to mediate improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eskenazi Primary Care patients at time of screening\n* 13-17 years old\n* Diagnosis of depression confirmed by Mini International Neuropsychiatric Interview (MINI) Kid Screen (with adolescent)\n* English speaking\n* Willingness to attend mind body skills group for duration of the intervention (10 sessions over approximately 10 weeks)\n\nExclusion Criteria:\n\n* History of bipolar disorder or psychosis\n* Acute and immediate risk of suicide, determined by clinical assessment\n* Lack of capacity to assent (adolescent) or lack of capacity to consent (parent/guardian)\n* Previous participation by the adolescent in the Eskenazi Mind Body Group intervention'}, 'identificationModule': {'nctId': 'NCT03363750', 'briefTitle': 'Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Pilot Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care', 'orgStudyIdInfo': {'id': '1707293729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mind-body-skills intervention', 'description': 'mind-body-skills group intervention offered weekly for 10 weeks', 'interventionNames': ['Behavioral: mind-body-skills group']}], 'interventions': [{'name': 'mind-body-skills group', 'type': 'BEHAVIORAL', 'description': 'mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement', 'armGroupLabels': ['mind-body-skills intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eskenazi Health Primary Care', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Michelle P Salyers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Center for Mind-Body Medicine', 'class': 'OTHER'}, {'name': 'Eskenazi Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michelle Salyers', 'investigatorAffiliation': 'Indiana University'}}}}