Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT06459596
• Lead Sponsor: Carnegie Mellon University

Brief 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

Detailed Description

The investigators will recruit 66 couples in which one person has type 2 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.

Study Timeline

• Study Start: 2022-11-22
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-14
• Primary Completion: 2025-02-25
• Study Completion: 2025-02-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• diagnosis of type 2 diabetes for one year

  • married or living with someone for at least one year who is willing to participate in the study as the study partner
  • age 18 and over
  • reliable access to the internet at home

Exclusion Criteria

• Non-English speakers

  • Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently --undergoing treatment for cancer)
  • Partner does not consent to participate in study
  • Partner has diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
self-management	baseline, 2 weeks, 6 weeks	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
diabetes distress	baseline, 2 weeks, 6 weeks	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

Secondary Outcome Measures

Name	Time	Method
depressive symptoms	baseline, 2 weeks, 6 weeks	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
life satisfaction	baseline, 2 weeks, 6 weeks	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
relationship quality	baseline, 2 weeks, 6 weeks	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

Trial Locations

Locations (1)

Carnegie Mellon University; 🇺🇸 Pittsburgh, Pennsylvania, United States