Recruiting

Cognitive Behavioral Intervention

Sponsor:

Emory University

Code:

NCT07522866

Conditions

Type1diabetes

Eligibility Criteria

Sex: All

Age: 31 - 70+

Healthy Volunteers: Accepted

Interventions

TranS-C Intervention Arm

Attention Control Enhanced Usual Care (EUC) Arm

Study Details

Brief summary:

This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.

Conditions

Type1diabetes

Study ID

NCT07522866

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 31 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Aged 31 to 75 years
  • Type 1 Diabetes for at least 1 year
  • One or more sleep health dimensions are out of range

Exclusion Criteria:

  • Non-English speaking
  • Recent night shift work or transmeridian travel
  • Life-limiting illness

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm

Participants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' variation in bed and wake times.

active comparator: Enhanced Usual Care (EUC) Arm

Participants will work with a health coach focused on enhanced usual care.

Interventions

TranS-C Intervention Arm

This 12-week cognitive behavioral intervention uses motivational interviewing and behavior change principles, focusing on self-efficacy and action planning. Participants target 7-9 hours of sleep per night, ≥85% sleep efficiency, and <60 minutes' variability in bed and wake times.

Components include sleep education and hygiene, nightly routines, the management of competing activities, sleep environment optimization, lifestyle modifications (e.g., avoiding caffeine and vigorous exercise before bedtime), screen time reduction, basic stress management (e.g., progressive muscle relaxation), and self-monitoring. Following a baseline visit, a research assistant conducts a 60-minute telehealth session via HIPAA-compliant Zoom/Teams, with booster sessions at weeks 4, 8, and 12. Sleep time is adjusted weekly based on sleep efficiency criteria.

Attention Control Enhanced Usual Care (EUC) Arm

This time- and attention-balanced 12-week condition will focus on enhancing usual care. After the initial baseline visit, the RA for this group will schedule a 60-minute telehealth appointment for the enhanced usual care. Follow-up sessions (weeks 4 and 8) will focus on health perceptions, care plans, and relationship-building rather than sleep promotion. The RA will encourage participants to share their progress and confidence in their self-set goals to foster engagement and retention. Participants may engage in self-initiated diabetes management, which will be tracked using a Diabetes Self-Management Tracking Form.

Primary outcome measure

  • Multidimensional sleep health composite score [ Time Frame: Baseline and post-intervention (14 weeks from baseline) ]
  • Glycated hemoglobin (HbA1C) [ Time Frame: Baseline and post-intervention (14 weeks from baseline) ]

Central Contacts and Locations

Central contacts

Stephanie Griggs, PhD, RN, FAAN

404-544-9915stephanie.griggs2@emory.edu

Locations

Emory University, Nell Hodgson Woodruff School of Nursing

Recruiting

Atlanta, Georgia, United States, 30322

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Glycemia
  • A1C
  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-06.