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Clinical Trials/NCT06459596
NCT06459596
Completed
Not Applicable

Communal Coping Intervention for Adults With Type 2 Diabetes

Carnegie Mellon University1 site in 1 country62 target enrollmentNovember 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Carnegie Mellon University
Enrollment
62
Locations
1
Primary Endpoint
self-management
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2022
End Date
February 25, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vicki Helgeson

Professor

Carnegie Mellon University

Eligibility Criteria

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

Outcomes

Primary Outcomes

self-management

Time Frame: 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

Time Frame: 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 Outcomes

  • depressive symptoms(baseline, 2 weeks, 6 weeks)
  • life satisfaction(baseline, 2 weeks, 6 weeks)
  • relationship quality(baseline, 2 weeks, 6 weeks)

Study Sites (1)

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