Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Communal Coping Intervention

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vicki Helgeson, Ph.D.; Phone Number: 4122682624; Email: vh2e@andrew.cmu.edu
• Study Contact Backup: Name: Abigail Vaughn, B.A.; Phone Number: 4122681793; Email: akunz@andrew.cmu.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Carnegie Mellon University
      • Contact: Vicki Helgeson, Ph.D.; Phone Number: 412-849-7213; Email: vh2e@andrew.cmu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; 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, abbreviated for ecological momentary assessment, 6-week followup
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	emotional, instrumental, informational support, criticism, overprotective behavior	baseline, abbreviated for for ecological momentary assessment, 6-week followup
change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period	self-report of diabetes communication, videotaped observations	baseline, abbreviated for for ecological momentary assessment, 6-week followup
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-efficacy with diabetes management	baseline, abbreviated for for ecological momentary assessment, 6-week followup

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: Juvenile Diabetes Research Foundation
• Investigators: Principal Investigator: Vicki Helgeson, Ph.D., Carnegie Mellon University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STUDY2022 00000269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No