Clinical trial NCT05925556: Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes
Official title: Communal Coping Intervention for Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2023-06-29
Enrollment: 80
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: 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

Detailed description: We will recruit 66 couples in which one person has type 1 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 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

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: 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
timeFrame: baseline, abbreviated for ecological momentary assessment, 6-week followup
measure: 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
timeFrame: baseline, abbreviated for ecological momentary assessment, 6-week followup
Secondary outcomes:
measure: change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome
timeFrame: baseline, 6 week followup
measure: 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
timeFrame: baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)
measure: 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
timeFrame: baseline, abbreviated for ecological momentary assessment, 6-week followup
measure: 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
timeFrame: baseline, abbreviated for ecological momentary assessment, 6-week followup
measure: 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
timeFrame: baseline, abbreviated for ecological momentary assessment, 6-week followup
Other outcomes:
measure: change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; also change over ecological momentary assessment period
timeFrame: baseline, abbreviated for ecological momentary assessment, 6-week followup
measure: 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
timeFrame: baseline, abbreviated for for ecological momentary assessment, 6-week followup
measure: change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period
timeFrame: baseline, abbreviated for for ecological momentary assessment, 6-week followup
measure: change in self-efficacy subscale from Multidimensional Diabetes Questionnaire from baseline to 6 weeks; higher numbers = greater efficacy; range = 0 to 100%; also change over ecological momentary assessment period
timeFrame: baseline, abbreviated for for ecological momentary assessment, 6-week followup
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Vicki Helgeson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: