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Reducing Diabetes Distress with Cognitive Behavioral Therapy in Type 1 Diabetes

This study is testing if a type of talk therapy called Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD), combined with using a Continuous Glucose Monitor (CGM), can help young adults with Type 1 Diabetes feel less stressed about their condition. You might be able to join if you are 18-64 years old, have had Type 1 Diabetes for at least 6 months, speak English or Spanish, and experience at least moderate diabetes distress. The study aims to see if CBT-DD improves both diabetes distress and blood sugar control. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 96 participants. It compares CBT-DD with CGM to using CGM alone in a randomized controlled trial.
What's involved
You would participate in approximately 10 virtual CBT sessions over 12 weeks and use a study-provided CGM for 6 months. You would also complete daily and weekly ecological momentary assessment (EMA) data collection.
Compensation
Not stated in the trial record.
Follow-up
After the main intervention, virtual study data will be collected at 3, 6, 9, and 12 months to assess long-term effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05000021

Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

Active, Not Recruiting
NAAges 18–64InterventionalHealth services
Albert Einstein College of Medicine
~96 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose MonitoringContinuous Glucose Monitoring (CGM)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diabetes Distress Levels
Measured over Baseline and 3 months post-intervention

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

2 sites across 1 states
New York2

Study leadership

  • Jeffrey Gonzalez, PhD · PRINCIPAL_INVESTIGATOR · Yeshiva University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Type 1 Diabetes (T1D) duration ≥6 months
English or Spanish speaking
At least moderate Diabetes Distress (DD) (score of ≥2 on T1D-Diabetes Distress Scale)
Stable insulin treatment regimen (insulin prescription, use of pump, etc.) for at least 3 months prior to study enrollment

Exclusion

Comorbid psychiatric condition, including depression, anxiety, or suicidality, which may be independently associated with the main outcomes of DD or glycemic control. Comorbid psychiatric conditions listed above are being excluded because CBT-DD currently centers on mitigating specifically diabetes distress to improve glycemic outcomes
In treatment for a psychological condition within the last 6 months or on a non-stable dose of psychiatric medication over the last 2 months
Developmental or sensory disability interfering with participation
Current pregnancy, as self-management and glycemic goals differ
Participation in another behavioral intervention study
Use of non-insulin medications or recent medical procedures that would impact glycemic control or use of CGM over the study
Minors
Subjects who do have the capacity to consent

What this trial measures

  • Diabetes Distress LevelsBaseline and 3 months post-intervention

    Diabetes distress will be assessed using the Problem Areas in Diabetes (PAID) scale. The PAID scale will be administered to each participant via the REDCap database. The PAID scale is a 20 item, self-report questionnaire that describes negative emotions related to diabetes commonly experienced by people with diabetes. For each item, participants are asked to provide a response describing the extent the item is currently a diabetes issue for them using a 5-point Likert scale ranging from 0 ("Not a problem") to 4 ("Serious problem"). Scores are added and multiplied by 1.25, yielding an overall possible score of 0-100. Scores will be summarized by study arm using basic descriptive statistics. Patients scoring \>=40 may be at the level of "emotional burnout" and warrant special attention.