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Behavioral Intervention
Communal Coping Intervention for Type 2 Diabetes
N/A
Recruiting
Led By Vicki S Helgeson, Ph.D.
Research Sponsored by Carnegie Mellon University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 and over
Be older than 18 years old
Must not have
Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently undergoing treatment for cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 6 weeks
Awards & highlights
Summary
This trial aims to create a program to help couples better cope with diabetes together. The program will focus on helping couples understand and manage diabetes as a team. Researchers will test this program in a clinical trial
Who is the study for?
This trial is for adults with Type 2 Diabetes who are in a relationship where both partners are willing to participate. The study aims to see if working together as a couple can help manage diabetes better.
What is being tested?
The trial is testing a new strategy called 'Communal Coping Intervention' which encourages couples to work together in managing one partner's Type 2 Diabetes, aiming to improve health outcomes.
What are the potential side effects?
Since this intervention involves behavioral strategies rather than medication, there may not be direct physical side effects. However, participants might experience emotional or relational changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a chronic illness more impactful than diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks, 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
diabetes distress
self-management
Secondary outcome measures
depressive symptoms
life satisfaction
relationship quality
Other outcome measures
emotional, instrumental, informational support, criticism, overprotective behavior
self-efficacy with diabetes management
self-report of diabetes communication, videotaped observations
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Communal Coping InterventionExperimental Treatment1 Intervention
Experimental: Communal Coping Intervention
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 (ecological momentary intervention) text messaging for 7 days following intervention
Group II: Diabetes Education Attention ControlActive Control1 Intervention
These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Communal Coping Intervention
2019
N/A
~50
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Who is running the clinical trial?
Carnegie Mellon UniversityLead Sponsor
77 Previous Clinical Trials
539,844 Total Patients Enrolled
Vicki S Helgeson, Ph.D.Principal InvestigatorCarnegie Mellon University
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