Clinical trial NCT06459596: Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes
Official title: Communal Coping Intervention for Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: diabetes distress
timeFrame: baseline, 2 weeks, 6 weeks
measure: self-management
timeFrame: baseline, 2 weeks, 6 weeks
Secondary outcomes:
measure: depressive symptoms
timeFrame: baseline, 2 weeks, 6 weeks
measure: life satisfaction
timeFrame: baseline, 2 weeks, 6 weeks
measure: relationship quality
timeFrame: baseline, 2 weeks, 6 weeks
Other outcomes:
measure: self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview
timeFrame: baseline, 2 weeks, 6 weeks
measure: emotional, instrumental, informational support, criticism, overprotective behavior
timeFrame: baseline, 2 weeks, 6 weeks
measure: self-report of diabetes communication, videotaped observations
timeFrame: baseline, 2 weeks, 6 weeks
measure: self-efficacy with diabetes management
timeFrame: baseline, 2 weeks, 6 weeks
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Vicki S Helgeson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: