RECRUITING

Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.

Official Title

Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care

Quick Facts

Study Start:2024-10-01
Study Completion:2027-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06405373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 30 years and older
  2. * Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
  3. * Elevated diabetes distress, defined as a score \>= 2.0 on the T1-DDAS core scale
  4. * English speaking
  1. * Does not receive diabetes care at UNC Endocrinology at Eastowne
  2. * Cannot commit to the pre-scheduled weekly, virtual sessions
  3. * Diagnosis of any major medical or psychiatric condition that would preclude participation
  4. * Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
  5. * Visual or auditory impairment that would interfere with participation in a group intervention
  6. * Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment

Contacts and Locations

Study Contact

Angela Fruik, MPH, RD
CONTACT
919-962-6348
angela.fruik@unc.edu

Principal Investigator

Anna Kahkoska, MD, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Anna Kahkoska, MD, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2027-09-15

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2027-09-15

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Type 1 diabetes
  • Diabetes distress
  • T1D
  • Emotional distress
  • Telehealth
  • SMART design

Additional Relevant MeSH Terms

  • Diabetes type1
  • Diabetes Mellitus, Type 1
  • Diabetes, Autoimmune
  • Diabetes Mellitus
  • Distress, Emotional