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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06285487
Other study ID # 23-1600
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date June 2026

Study information

Verified date February 2024
Source University of Colorado, Denver
Contact Lauren Gulley, PhD
Phone 720-777-8379
Email lauren.gulley@colostate.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria: - Type 2 Diabetes diagnosis = 3 months - Age 12-17yr - Elevated depression symptoms - HbA1c =7.0% Exclusion Criteria: - Currently receiving psychotherapy from a licensed counselor - Psychotropic meds <8 weeks

Study Design


Intervention

Behavioral:
Group Program
Participants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd.

Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of IPT-T2D Assessed by likeability, credibility, and descriptions by adolescents, parents, and facilitators 3 Months
Primary Depression Changes Assessed by CESD 3 Months
Primary Changes in Glycemic Control Assessed by changes in HbA1c 3 Months
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