Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes
NCT Number: NCT06459596
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2
Interventions: BEHAVIORAL: Communal Coping Intervention
Sponsor: Carnegie Mellon University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-22
Completion Date: 2025-06-30
Locations: Carnegie Mellon University, Pittsburgh, Pennsylvania, 15213, United States

Summary:
The investigators plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, the investigators will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T12

Primary Outcome Measures: diabetes distress, 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 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 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, baseline, 2 weeks, 6 weeks|self-management, change in Summary of Diabetes Self-Care Activities from baseline to 6 weeks; higher score = better self-care; range 1-5; also change over ecological momentary assessment period, baseline, 2 weeks, 6 weeks
Secondary Outcome Measures: depressive symptoms, 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, baseline, 2 weeks, 6 weeks|life satisfaction, 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, baseline, 2 weeks, 6 weeks|relationship quality, 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, baseline, 2 weeks, 6 weeks
Other Outcome Measures: self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview, change in communal coping from baseline to 6 weeks; higher = more communal coping; range = 0 to 10; also change over ecological momentary assessment period, baseline, 2 weeks, 6 weeks|emotional, instrumental, informational support, criticism, overprotective behavior, 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, baseline, 2 weeks, 6 weeks|self-report of diabetes communication, videotaped observations, change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period, baseline, 2 weeks, 6 weeks|self-efficacy with diabetes management, 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, baseline, 2 weeks, 6 weeks