What side effects are associated with this type of intervention?

The most common treatment for Type 1 Diabetes is insulin therapy, which can cause side effects such as hypoglycemia, weight gain, and injection site reactions. Psychological interventions, like communal coping strategies that enhance shared appraisal of diabetes and increase patient-partner collaboration, typically have fewer physical side effects but may present emotional challenges as patients and their partners work together to manage the disease.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes that focus on improving self-care behaviors and patient collaboration. While specific communal coping interventions are not mentioned, psychological and behavioral interventions such as cognitive behavioral therapy (CBT) have shown promise in managing distress and improving treatment adherence among youths with Type 1 Diabetes. Additionally, peer support interventions have been studied for their effectiveness in reducing fear of hypoglycemia and enhancing diabetes self-care behaviors.

What other types of research exist?

Promising alternatives to Communal Coping Intervention for Type 1 Diabetes patients include: 1) Shared Medical Appointments (SMAs) which utilize multidisciplinary teams to improve glycemic control and quality of life, 2) Peer Support Programs that address diabetes self-care behaviors and reduce fear of hypoglycemia, and 3) Internet-based interventions like TEENCOPE™ for coping skills and Managing Diabetes for education, which have shown to improve self-efficacy and quality of life.

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Communal Coping Intervention for Type 1 Diabetes

N/A

Recruiting

Led By Vicki 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

Diagnosis of type 1 diabetes for at least one year

Must not have

Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently undergoing treatment for cancer)

Non-English speakers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program that helps couples work together to manage type 1 diabetes. It targets couples where one partner has diabetes, aiming to improve their teamwork in handling the disease. The program includes setting shared goals and receiving regular support messages.

Who is the study for?

This trial is for adults over 18 with Type 1 Diabetes who've had it for at least a year. They must be married or living with a partner for the same duration, who's also willing to join the study. Participants need internet access and can't have other major illnesses overshadowing their diabetes. Non-English speakers and partners with diabetes are excluded.

What is being tested?

The trial is testing a new 'communal coping intervention' designed to help couples where one partner has Type 1 Diabetes work together better in managing the condition. It's about sharing the challenge of diabetes care between patient and partner through an online program.

What are the potential side effects?

Since this intervention involves psychological support rather than medication, traditional physical side effects aren't expected. However, participants may experience emotional discomfort or relationship dynamics changes as they adapt to new ways of coping together.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with type 1 diabetes for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic illness more impactful than diabetes.

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 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

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

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

Secondary study objectives

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

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

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

+2 more

Other study objectives

change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; also change over ecological momentary assessment period

change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period

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

+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

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: 1. establishment of rapport 2. shared stressor recollection 3. communal coping education 4. application of appraisal to diabetes 5. we-statements to reframe diabetes as shared 6. facilitated discussion between couple members to identify each person's needs with active listening 7. collaborative implementation intentions 8. EMI 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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Type 1 Diabetes (T1D) is insulin therapy, which involves administering exogenous insulin to compensate for the body's inability to produce insulin. This is essential for regulating blood glucose levels and preventing complications associated with hyperglycemia. Additionally, psychosocial interventions like the Communal Coping Intervention, which enhance shared appraisal of diabetes and increase patient-partner collaboration, are important. These interventions help improve treatment adherence and emotional well-being by creating a supportive environment, addressing both the psychological and social challenges of managing T1D. This holistic approach is vital for improving overall disease management and quality of life for T1D patients.

Short-term effects of coping skills training in school-age children with type 1 diabetes.Effects of Cognitive Behavioral Therapy-Based Intervention on Improving Glycaemic, Psychological, and Physiological Outcomes in Adult Patients With Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials.An examination of the communal coping process in recently diagnosed diabetes.