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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

No Placebo-Only Group

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

diabetes distress

self-management

Secondary study objectives

depressive symptoms

life satisfaction

relationship quality

Other study objectives

emotional, instrumental, informational support, criticism, overprotective behavior

self-efficacy with diabetes management

self-report of diabetes communication, videotaped observations

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 2Eligibility criteria met