Depression in Youth Onset Type 2 Diabetes

NCT ID: NCT06285487

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Group Program

Intervention Type BEHAVIORAL

Participants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd.

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.

Group Type EXPERIMENTAL

Group Program

Intervention Type BEHAVIORAL

Participants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd.

Interventions

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Group Program

Participants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Central Contacts

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Lauren Gulley, PhD

Role: CONTACT

Phone: 720-777-8379

Email: [email protected]

Other Identifiers

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23-1600

Identifier Type: -

Identifier Source: org_study_id