Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes

NCT ID: NCT06459596

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2025-02-25

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

Detailed Description

The investigators will recruit 66 couples in which one person has type 2 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Communal Coping Intervention

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

Group Type: EXPERIMENTAL

Communal Coping Intervention

Intervention Type: BEHAVIORAL

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

Diabetes Education Attention Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Communal Coping Intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carnegie Mellon University

OTHER

Sponsor Role: lead

Responsible Party

Vicki Helgeson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vicki S Helgeson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

Locations

Carnegie Mellon University

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY2024_00000148

Identifier Type: -

Identifier Source: org_study_id