Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 text messaging for 7 days following intervention |
Behavioral: Communal Coping Intervention
The components of the intervention were described in the experimental arm.
|
| No Intervention: Diabetes Education Attention Control These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group) |
Outcome Measures
Primary Outcome Measures
- change in Type 1 Diabetes Distress Scale (Fisher et al., 2015) from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for ecological momentary assessment, 6-week followup]
diabetes distress
- change in Self-Care Inventory from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for ecological momentary assessment, 6-week followup]
self-management
Secondary Outcome Measures
- change in hemoglobin a1c from baseline to 6 weeks [baseline, 6 week followup]
test kit
- change in time in range from baseline to 6 weeks; 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)]
data downloaded from continuous glucose monitors
- change in Center for Epidemiological Depression Scale from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for ecological momentary assessment, 6-week followup]
depressive symptoms
- change in Diener's life satisfaction scale from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for ecological momentary assessment, 6-week followup]
life satisfaction
- change in Quality of Marriage Index and intimacy subscale from Personal Assessment of Intimacy in Relationships from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for ecological momentary assessment, 6-week followup]
relationship quality
Other Outcome Measures
- change in communal coping from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for ecological momentary assessment, 6-week followup]
self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview
- change in social support and negative social interactions from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for for ecological momentary assessment, 6-week followup]
emotional, instrumental, informational support, criticism, overprotective behavior
- change in diabetes communication from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for for ecological momentary assessment, 6-week followup]
self-report of diabetes communication, videotaped observations
- change in self-efficacy subscale from Multidimensional Diabetes Questionnaire from baseline to 6 weeks; also change over ecological momentary assessment period [baseline, abbreviated for for ecological momentary assessment, 6-week followup]
self-efficacy with diabetes management
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Carnegie Mellon University
- Juvenile Diabetes Research Foundation
Investigators
- Principal Investigator: Vicki Helgeson, Ph.D., Carnegie Mellon University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY2022 00000269