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Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communal Coping Intervention
Sponsored by
Carnegie Mellon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carnegie Mellon UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Communal Coping Intervention

Diabetes Education Attention Control

Arm Description

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 text messaging for 7 days following intervention

These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group)

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome
test kit
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
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
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
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

Full Information

First Posted
June 22, 2023
Last Updated
August 3, 2023
Sponsor
Carnegie Mellon University
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05925556
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carnegie Mellon University
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Communal Coping Intervention
Arm Type
Experimental
Arm Description
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 text messaging for 7 days following intervention
Arm Title
Diabetes Education Attention Control
Arm Type
No Intervention
Arm Description
These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group)
Intervention Type
Behavioral
Intervention Name(s)
Communal Coping Intervention
Intervention Description
The components of the intervention were described in the experimental arm.
Primary Outcome Measure Information:
Title
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
Description
diabetes distress
Time Frame
baseline, abbreviated for ecological momentary assessment, 6-week followup
Title
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
Description
self-management
Time Frame
baseline, abbreviated for ecological momentary assessment, 6-week followup
Secondary Outcome Measure Information:
Title
change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome
Description
test kit
Time Frame
baseline, 6 week followup
Title
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
Description
data downloaded from continuous glucose monitors
Time Frame
baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)
Title
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
Description
depressive symptoms
Time Frame
baseline, abbreviated for ecological momentary assessment, 6-week followup
Title
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
Description
life satisfaction
Time Frame
baseline, abbreviated for ecological momentary assessment, 6-week followup
Title
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
Description
relationship quality
Time Frame
baseline, abbreviated for ecological momentary assessment, 6-week followup
Other Pre-specified Outcome Measures:
Title
change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; also change over ecological momentary assessment period
Description
self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview
Time Frame
baseline, abbreviated for ecological momentary assessment, 6-week followup
Title
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
Description
emotional, instrumental, informational support, criticism, overprotective behavior
Time Frame
baseline, abbreviated for for ecological momentary assessment, 6-week followup
Title
change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period
Description
self-report of diabetes communication, videotaped observations
Time Frame
baseline, abbreviated for for ecological momentary assessment, 6-week followup
Title
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
Description
self-efficacy with diabetes management
Time Frame
baseline, abbreviated for for ecological momentary assessment, 6-week followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicki Helgeson, Ph.D.
Phone
4122682624
Email
vh2e@andrew.cmu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Vaughn, B.A.
Phone
4122681793
Email
akunz@andrew.cmu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicki Helgeson, Ph.D.
Organizational Affiliation
Carnegie Mellon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carnegie Mellon University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicki Helgeson, Ph.D.
Phone
412-849-7213
Email
vh2e@andrew.cmu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes

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