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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
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

Study Summary

This trial will test if a brief intervention can help couples work together to manage diabetes. #diabetesmanagement #couplescoping

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.Check my eligibility
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.See study design
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.

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

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: 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
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

Find a Location

Who is running the clinical trial?

Carnegie Mellon UniversityLead Sponsor
76 Previous Clinical Trials
539,850 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,704 Total Patients Enrolled
Vicki Helgeson, Ph.D.Principal InvestigatorCarnegie Mellon University

Media Library

Communal Coping Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05925556 — N/A
Type 1 Diabetes Research Study Groups: Communal Coping Intervention, Diabetes Education Attention Control
Type 1 Diabetes Clinical Trial 2023: Communal Coping Intervention Highlights & Side Effects. Trial Name: NCT05925556 — N/A
Communal Coping Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05925556 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation presently have space for new participants?

"This clinical trial is still open for enrolment. Its original posting was on August 2nd, 2023 and it has been amended as recently as August 3rd of the same year."

Answered by AI

What is the ultimate purpose of this medical trial?

"The fundamental aim of this investigation, which will be monitored over baseline, condensed for ecological momentary assessment, and a 6-week followup duration is to assess the transformation in Self-Care Inventory from origin to 6 weeks; higher evaluation indicating better self-care (range: 1-5); with an analogous analysis during the period of ecological momentary assessment. Auxiliary objectives include measuring transition in time within range starting at baseline up until 6 weeks; larger figures implying more excellent outcome (range 0 to 100%); as well as alteration through ecological momentary appraisal specified by data acquired from continuous glucose monitors. Also being measured are fluctuations in Center for"

Answered by AI

What is the magnitude of involvement in this research trial?

"Affirmative. According to clinicaltrials.gov, this clinical trial is actively seeking out participants and has been updated as recently at August 3rd 2023. The study requires 66 patients from one location only."

Answered by AI

Who else is applying?

What site did they apply to?
Carnegie Mellon University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes
Vicki Helgeson 2023. "Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05925556.
All > Type 1 Diabetes
~44 spots leftby Mar 2025
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