Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-22 @ 4:50 PM
Study NCT ID:
NCT05925556
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for ecological momentary assessment, 6-week followup', 'description': 'self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview'}, {'measure': 'change in social support and negative social interactions from baseline to 6 weeks; higher numbers = more support or more negative interactions; range = 1-7; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for for ecological momentary assessment, 6-week followup', 'description': 'emotional, instrumental, informational support, criticism, overprotective behavior'}, {'measure': 'change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for for ecological momentary assessment, 6-week followup', 'description': 'self-report of diabetes communication, videotaped observations'}, {'measure': 'change in self-efficacy subscale from Multidimensional Diabetes Questionnaire from baseline to 6 weeks; higher numbers = greater efficacy; range = 0 to 100%; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for for ecological momentary assessment, 6-week followup', 'description': 'self-efficacy with diabetes management'}], 'primaryOutcomes': [{'measure': 'change in Type 1 Diabetes Distress Scale (Fisher et al., 2015) from baseline to 6 weeks; higher scores = more distress; range 1-6; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for ecological momentary assessment, 6-week followup', 'description': 'diabetes distress'}, {'measure': 'change in Self-Care Inventory from baseline to 6 weeks; higher score = better self-care; range 1-5; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for ecological momentary assessment, 6-week followup', 'description': 'self-management'}], 'secondaryOutcomes': [{'measure': 'change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome', 'timeFrame': 'baseline, 6 week followup', 'description': 'test kit'}, {'measure': 'change in time in range from baseline to 6 weeks; higher numbers = better outcome; range 0 to 100%; also change over ecological momentary assessment period', 'timeFrame': 'baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)', 'description': 'data downloaded from continuous glucose monitors'}, {'measure': 'change in Center for Epidemiological Depression Scale from baseline to 6 weeks; higher numbers = more depressive symptoms; range = 0 to 30; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for ecological momentary assessment, 6-week followup', 'description': 'depressive symptoms'}, {'measure': "change in Diener's life satisfaction scale from baseline to 6 weeks; higher numbers= more life satisfaction; range = 1-7; also change over ecological momentary assessment period", 'timeFrame': 'baseline, abbreviated for ecological momentary assessment, 6-week followup', 'description': 'life satisfaction'}, {'measure': 'change in Quality of Marriage Index and intimacy subscale from Personal Assessment of Intimacy in Relationships from baseline to 6 weeks; higher numbers = better; range = 1 to 7; also change over ecological momentary assessment period', 'timeFrame': 'baseline, abbreviated for ecological momentary assessment, 6-week followup', 'description': 'relationship quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'We plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, we will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T1D', 'detailedDescription': 'We will recruit 66 couples in which one person has type 1 diabetes. Power is based on effect sizes from previous couple intervention studies and meta-analyses on primary outcomes. Couples will be randomly assigned to either a communal coping intervention or an attention (diabetes education) control group. All couples will come to the laboratory or meet via zoom, complete a baseline questionnaire assessment (primary and secondary outcomes, mediators) and have a videotaped conversation about how they cope with diabetes. The intervention group will receive the communal coping intervention. Couples in the intervention group will identify 5 collaborative implementation intentions, whereas controls will identify 5 individual implementation intentions. After the in-person session, couples will individually complete a daily diary at the end of the day for 14 consecutive days which focuses on daily communication, mood, and patient self-care. During the first 7 days, the intervention group will receive two text messages per day (morning focus on shared appraisal, evening focus on one of collaborative implementation intentions identified during in-person session). An in-person follow-up interview will take place 6 weeks after the initial session, during which primary outcomes, secondary outcomes, and mediators will be assessed and the videotaped conversation repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of type 1 diabetes for at least one year\n\n * married or living with someone for at least one year who is willing to participate in the study as the study partner\n * age 18 and over\n * reliable access to the internet at home\n\nExclusion Criteria:\n\n* Non-English speakers\n* Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently undergoing treatment for cancer)\n* Partner does not consent to participate in study\n* Partner has diabetes'}, 'identificationModule': {'nctId': 'NCT05925556', 'briefTitle': 'Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Carnegie Mellon University'}, 'officialTitle': 'Communal Coping Intervention for Adults With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'STUDY2022 00000269'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Communal Coping Intervention', 'description': "The intervention consists of a single session brief communal coping intervention followed by 7 days of intervention prompts delivered via text message to help couples generalize what they have learned into their daily life. There are 9 components to the intervention:\n\n1. establishment of rapport\n2. shared stressor recollection\n3. communal coping education\n4. application of appraisal to diabetes\n5. we-statements to reframe diabetes as shared\n6. facilitated discussion between couple members to identify each person's needs with active listening\n7. collaborative implementation intentions\n8. EMI text messaging for 7 days following intervention", 'interventionNames': ['Behavioral: Communal Coping Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Diabetes Education Attention Control', 'description': 'These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group)'}], 'interventions': [{'name': 'Communal Coping Intervention', 'type': 'BEHAVIORAL', 'description': 'The components of the intervention were described in the experimental arm.', 'armGroupLabels': ['Communal Coping Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Carnegie Mellon University', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Vicki Helgeson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carnegie Mellon University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carnegie Mellon University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vicki Helgeson', 'investigatorAffiliation': 'Carnegie Mellon University'}}}}