Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALCommunal Coping Intervention
The components of the intervention were described in the experimental arm.
Sponsors
Carnegie Mellon University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| self-report of diabetes communication, videotaped observations | baseline, 2 weeks, 6 weeks | change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period |
| emotional, instrumental, informational support, criticism, overprotective behavior | baseline, 2 weeks, 6 weeks | change in social support and negative social interactions from baseline to 6 weeks; higher numbers = more support or more negative interactions; range = 1-7; also change over ecological momentary assessment period |
| self-efficacy with diabetes management | baseline, 2 weeks, 6 weeks | change in self-efficacy subscale from Multidimensional Diabetes Questionnaire from baseline to 6 weeks; higher numbers = greater efficacy; range = 0 to 100%; also change over ecological momentary assessment period |
| self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview | baseline, 2 weeks, 6 weeks | change in communal coping from baseline to 6 weeks; higher = more communal coping; range = 0 to 10; also change over ecological momentary assessment period |
Countries
United States
Outcome results
None listed