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Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes

Carnegie Mellon University logo

Carnegie Mellon University

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: Communal Coping Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06459596
STUDY2024_00000148

Details and patient eligibility

About

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

Full 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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

62 participants in 2 patient groups

Communal Coping Intervention
Experimental group
Description:
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
Treatment:
Behavioral: Communal Coping Intervention
Diabetes Education Attention Control
No Intervention group
Description:
These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group)

Trial contacts and locations

1

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Central trial contact

Abigail Vaughn, B.A.; Vicki Helgeson, Ph.D.

Data sourced from clinicaltrials.gov

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