Clinical Trials Directory

Trials / Completed

CompletedNCT05925556

Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

Communal Coping Intervention for Adults With Type 1 Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Carnegie Mellon University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCommunal Coping InterventionThe components of the intervention were described in the experimental arm.

Timeline

Start date
2023-08-02
Primary completion
2025-03-19
Completion
2025-03-19
First posted
2023-06-29
Last updated
2025-05-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05925556. Inclusion in this directory is not an endorsement.