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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Communal Coping Intervention | The 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.