Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Communal Coping Intervention
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
-
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
-
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
- Arm && Interventions
Group Intervention Description Communal Coping Intervention Communal Coping Intervention Experimental: Communal Coping Intervention The intervention consists of a single session brief communal coping intervention followed by 7 days of intervention prompts delivered via text message to help couples generalize what they have learned into their daily life. There are 9 components to the intervention: establishment of rapport, shared stressor recollection, communal coping education, application of appraisal to diabetes, we-statements to reframe diabetes as shared, facilitated discussion between couple members to identify each person's needs with active listening, collaborative implementation intentions, EMI (ecological momentary intervention) text messaging for 7 days following intervention
- 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