Communal Coping Intervention for Adults With Type 1 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- Carnegie Mellon University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Vicki Helgeson
Professor
Carnegie Mellon University
Eligibility Criteria
Inclusion Criteria
- •diagnosis of type 1 diabetes for at least 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
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
Time Frame: baseline, abbreviated for ecological momentary assessment, 6-week followup
diabetes distress
change in Self-Care Inventory from baseline to 6 weeks; higher score = better self-care; range 1-5; also change over ecological momentary assessment period
Time Frame: baseline, abbreviated for ecological momentary assessment, 6-week followup
self-management
Secondary Outcomes
- change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome(baseline, 6 week followup)
- 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, abbreviated for ecological momentary assessment, 6-week followup)
- 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, abbreviated for ecological momentary assessment, 6-week followup)
- change in time in range from baseline to 6 weeks; higher numbers = better outcome; range 0 to 100%; also change over ecological momentary assessment period(baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 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(baseline, abbreviated for ecological momentary assessment, 6-week followup)