Depression in Youth Onset Type 2 Diabetes

February 22, 2024 updated by: University of Colorado, Denver
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interpersonal Psychotherapy adapted for Type 2 Diabetes
Participants in the IPT-T2D will receive 1 hour weekly IPT from a licensed psychologist in a group setting for 6 weeks.
Behavioral: Group Program
Participants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd.
Experimental: Health Education adapted for Type 2 Diabetes
Participants in the Health Education-T2D will receive 1 hour weekly Health Education lessons from a licensed psychologist in a group setting for 6 weeks.
Behavioral: Group Program
Participants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of IPT-T2D
Time Frame: 3 Months
Assessed by likeability, credibility, and descriptions by adolescents, parents, and facilitators
3 Months
Depression Changes
Time Frame: 3 Months
Assessed by CESD
3 Months
Changes in Glycemic Control
Time Frame: 3 Months
Assessed by changes in HbA1c
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-1600

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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