Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Communal Coping Intervention for Adults With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459596
• Other study ID #: STUDY2024_00000148
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Carnegie Mellon University
• Contact: Vicki Helgeson, Ph.D.
• Phone: 4128497213
• Email: vh2e[@]andrew.cmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 30, 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Communal Coping Intervention
The components of the intervention were described in the experimental arm.

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Carnegie Mellon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview	change in communal coping from baseline to 6 weeks; higher = more communal coping; range = 0 to 10; also change over ecological momentary assessment period	baseline, 2 weeks, 6 weeks
Other	emotional, instrumental, informational support, criticism, overprotective behavior	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	baseline, 2 weeks, 6 weeks
Other	self-report of diabetes communication, videotaped observations	change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period	baseline, 2 weeks, 6 weeks
Other	self-efficacy with diabetes management	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	baseline, 2 weeks, 6 weeks
Primary	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
Primary	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	depressive symptoms	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	baseline, 2 weeks, 6 weeks
Secondary	life satisfaction	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	baseline, 2 weeks, 6 weeks
Secondary	relationship quality	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	baseline, 2 weeks, 6 weeks