NCT06285487

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
0mo left

Started Feb 2024

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Feb 2024Jun 2026

Study Start

First participant enrolled

February 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

February 15, 2024

Last Update Submit

February 22, 2024

Conditions

Type 2 DiabetesDepression

Outcome Measures

Primary Outcomes (3)

  • Acceptability of IPT-T2D

    Assessed by likeability, credibility, and descriptions by adolescents, parents, and facilitators

    3 Months

  • Depression Changes

    Assessed by CESD

    3 Months

  • Changes in Glycemic Control

    Assessed by changes in HbA1c

    3 Months

Study Arms (2)

Interpersonal Psychotherapy adapted for Type 2 Diabetes

EXPERIMENTAL

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

Health Education adapted for Type 2 Diabetes

EXPERIMENTAL

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

Interventions

Group ProgramBEHAVIORAL

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

Health Education adapted for Type 2 DiabetesInterpersonal Psychotherapy adapted for Type 2 Diabetes

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Type 2 Diabetes diagnosis ≥ 3 months
  • Age 12-17yr
  • Elevated depression symptoms
  • HbA1c ≥7.0%

You may not qualify if:

  • Currently receiving psychotherapy from a licensed counselor
  • Psychotropic meds \<8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Depression

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Central Study Contacts

Lauren Gulley, PhD

CONTACT

720-777-8379lauren.gulley@colostate.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 29, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

US(1)