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Completed

NCT Number: NCT05925556

Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communal Coping Intervention

Behavioral

The components of the intervention were described in the experimental arm.

Primary outcomes

  1. 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

    Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup

    diabetes distress

  2. 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

    Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup

    self-management

Secondary outcomes

  1. change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome

    Time frame: baseline, 6 week followup

    test kit

  2. 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

    Time frame: 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

  3. 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

    Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup

    depressive symptoms

  4. 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

    Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup

    life satisfaction

  5. 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

    Time frame: baseline, abbreviated for ecological momentary assessment, 6-week followup

    relationship quality

Other outcomes

  1. change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; also change over ecological momentary assessment period

    Time frame: 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

  2. 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

    Time frame: baseline, abbreviated for for ecological momentary assessment, 6-week followup

    emotional, instrumental, informational support, criticism, overprotective behavior

  3. change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period

    Time frame: baseline, abbreviated for for ecological momentary assessment, 6-week followup

    self-report of diabetes communication, videotaped observations

  4. 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

    Time frame: baseline, abbreviated for for ecological momentary assessment, 6-week followup

    self-efficacy with diabetes management

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

Communal Coping Intervention for Adults With Type 1 Diabetes

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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