NCT00005116

Brief Summary

Depression is one of the most common emotional problems among youths with insulin dependent diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while and may have a role in later complications of the medical condition. And yet, there are no psychological interventions appropriate for such youngsters. The purpose of this study is to modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot test'' the treatment. The youngsters to be recruited are those being cared for at the Diabetes Clinic of the Children's Hospital of Pittsburgh. The treatment includes a 3- month phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later follow-up evaluations.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 13, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2000

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

April 13, 2000

Last Update Submit

March 1, 2010

Conditions

DepressionDiabetes Mellitus, Insulin-Dependent

Keywords

depression

Interventions

psychotherapyBEHAVIORAL

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • IDDM duration of less than 10 years
  • No major medical disorder other than IDDM
  • No psychotropic medications
  • Meets psychiatric diagnostic criteria for depression
  • Parent and child willing to participate

You may not qualify if:

  • Does not live withing commuting distance
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WPIC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

DepressionDiabetes Mellitus, Type 1

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Dr. Maria Kovacs

    U. Of Pittsburgh School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

April 13, 2000

First Posted

April 14, 2000

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)