Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Communal Coping Intervention for Adults With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925556
• Other study ID #: STUDY2022 00000269
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Carnegie Mellon University
• Contact: Vicki Helgeson, Ph.D.
• Phone: 4122682624
• Email: vh2e[@]andrew.cmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• 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 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

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 (2)

Lead Sponsor	Collaborator
Carnegie Mellon University	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; also change over ecological momentary assessment period	self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview	baseline, abbreviated for ecological momentary assessment, 6-week followup
Other	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	emotional, instrumental, informational support, criticism, overprotective behavior	baseline, abbreviated for for ecological momentary assessment, 6-week followup
Other	change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period	self-report of diabetes communication, videotaped observations	baseline, abbreviated for for ecological momentary assessment, 6-week followup
Other	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	self-efficacy with diabetes management	baseline, abbreviated for for ecological momentary assessment, 6-week followup
Primary	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	diabetes distress	baseline, abbreviated for ecological momentary assessment, 6-week followup
Primary	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	self-management	baseline, abbreviated for ecological momentary assessment, 6-week followup
Secondary	change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome	test kit	baseline, 6 week followup
Secondary	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	data downloaded from continuous glucose monitors	baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)
Secondary	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	depressive symptoms	baseline, abbreviated for ecological momentary assessment, 6-week followup
Secondary	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	life satisfaction	baseline, abbreviated for ecological momentary assessment, 6-week followup
Secondary	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	relationship quality	baseline, abbreviated for ecological momentary assessment, 6-week followup