Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes

NCT06459596 | Completed

• 1 other identifier: STUDY2024_00000148
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, the investigators will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T12

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• diabetes distress

  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 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 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, 2 weeks, 6 weeks

• self-management

  change in Summary of Diabetes Self-Care Activities from baseline to 6 weeks; higher score = better self-care; range 1-5; also change over ecological momentary assessment period

  baseline, 2 weeks, 6 weeks

Secondary Outcomes (3)

• depressive symptoms

  baseline, 2 weeks, 6 weeks

• life satisfaction

  baseline, 2 weeks, 6 weeks

• relationship quality

  baseline, 2 weeks, 6 weeks

Other Outcomes (4)

• self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview

  baseline, 2 weeks, 6 weeks

• emotional, instrumental, informational support, criticism, overprotective behavior

  baseline, 2 weeks, 6 weeks

• self-report of diabetes communication, videotaped observations

  baseline, 2 weeks, 6 weeks

Study Arms (2)

Communal Coping Intervention

EXPERIMENTAL

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 (ecological momentary intervention) 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 2 diabetes for 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

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Vicki S 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: May 7, 2024
• First Posted: June 14, 2024
• Study Start: November 22, 2022
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)