Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

NCT05925556 | Completed

• 1 other identifier: STUDY2022 00000269
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

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

  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

  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

  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

  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

  baseline, abbreviated for ecological momentary assessment, 6-week followup

Other Outcomes (4)

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

  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

  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

  baseline, abbreviated for for ecological momentary assessment, 6-week followup

Study Arms (2)

Communal Coping Intervention

EXPERIMENTAL

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

Behavioral: Communal Coping Intervention

Diabetes Education Attention Control

NO INTERVENTION

These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group)

Interventions

Communal Coping Intervention BEHAVIORAL

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

Communal Coping Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carnegie Mellon University: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vicki Helgeson, Ph.D.

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: June 29, 2023
• Study Start: August 2, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)