Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Communal Coping Intervention for Adults With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Communal Coping Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Communal Coping Intervention<br>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<br>* The components of the intervention were described in the experimental arm.<br>|
| No Intervention: Diabetes Education Attention Control<br>These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | diabetes distress | baseline, abbreviated for ecological momentary assessment, 6-week followup | 
| 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 | self-management | baseline, abbreviated for ecological momentary assessment, 6-week followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome | test kit | baseline, 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 | data downloaded from continuous glucose monitors | baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 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 | depressive symptoms | 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 | life satisfaction | baseline, abbreviated for ecological momentary assessment, 6-week followup | 
| 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 | relationship quality | baseline, abbreviated for ecological momentary assessment, 6-week followup |