NCT05540704 Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
| NCT ID | NCT05540704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 235 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 235 participants in total. It began in 2023-04-04 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Primary Cohort Inclusion Criteria: * 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 Inclusion Criteria: * 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 Exclusion Criteria: * Active suicidal ideation * Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses * Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years * Current substance abuse disorder or current or past psychotic disorder * NonEnglish speaking
Contact & Investigator
Rhonda Merwin, PhD
PRINCIPAL INVESTIGATOR
Duke University faculty
Frequently Asked Questions
Who can join the NCT05540704 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 50 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05540704 currently recruiting?
Yes, NCT05540704 is actively recruiting participants. Contact the research team at drm72@duke.edu for enrollment information.
Where is the NCT05540704 trial being conducted?
This trial is being conducted at Durham, United States, Providence, United States.
Who is sponsoring the NCT05540704 clinical trial?
NCT05540704 is sponsored by Duke University. The principal investigator is Rhonda Merwin, PhD at Duke University faculty. The trial plans to enroll 235 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.