Type 1 Diabetes (T1D) Clinical Trials

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Changing the T1DE (Type 1 Diabetes Eating Disorders): A Randomized Controlled Trial Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling and a Waitlist Control

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning. The main questions are: Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress? Does one treatment do better than the other? How do the treatments work, if they work, and for whom? Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 50
Healthy Volunteers: f
View:

• 16-50 years of age

• Diagnosis of Type 1 diabetes

• Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)

• Independently manages diabetes (not reliant on a caregiver)

⁃ Expansion Cohort

• 16-50 years of age

• Diagnosis of Type 1 diabetes

• DEPR-R score \>=20 but does not meet criteria for the primary cohort

⁃ Primary and Expansion Cohort

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Rhode Island
Brown University
RECRUITING
Providence
Contact Information
Primary
Dottie R Mayo, BA
drm72@duke.edu
(919) 668-1935
Backup
Rhonda Merwin, PhD
rhonda.merwin@duke.edu
(919) 681-7231
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2027-09
Participants
Target number of participants: 235
Treatments
Experimental: Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE)
ACT-T1DE consists of 12 sessions of flexible ACT protocol tailored to the unique conditions and needs of type 1 diabetes eating disorders. The protocol is based on an initial pilot study (Merwin et al., 2021); however, the current protocol has been modified, based on key stakeholder feedback and to optimize real-world implementation. Modifications include transition from the use of a mobile app to a text messaging platform and a combination of in-person and virtual visits.
Active_comparator: Supportive Diabetes Counseling (SDC)
The SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, psychoeducation about diabetes and its management and management problems, and goal setting, informed by the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors framework.
No_intervention: 6-Month Waitlist Control
Participants assigned to the Waitlist Control complete assessments but do not receive intervention.
Related Therapeutic Areas
Sponsors
Collaborators: The Miriam Hospital, Breakthrough T1D
Leads: Duke University

This content was sourced from clinicaltrials.gov