Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Communal Coping Intervention

• Registration Number: NCT05925556
• Lead Sponsor: Carnegie Mellon University

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.

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-29
• Study Start: 2023-08-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-03
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Communal Coping Intervention	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: 1. establishment of rapport 2. shared stressor recollection 3. communal coping education 4. application of appraisal to diabetes 5. we-statements to reframe diabetes as shared 6. facilitated discussion between couple members to identify each person's needs with active listening 7. collaborative implementation intentions 8. EMI text messaging for 7 days following intervention

Primary Outcome Measures

Name	Time	Method
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	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	baseline, abbreviated for ecological momentary assessment, 6-week followup	self-management

Secondary Outcome Measures

Name	Time	Method
change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome	baseline, 6 week followup	test kit
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	depressive symptoms
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	life satisfaction
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)	data downloaded from continuous glucose monitors
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	relationship quality

Trial Locations

Locations (1)

Carnegie Mellon University; 🇺🇸 Pittsburgh, Pennsylvania, United States