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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005116
Other study ID # KOVACSM (completed)
Secondary ID R01DK025568
Status Completed
Phase N/A
First received April 13, 2000
Last updated March 1, 2010

Study information

Verified date March 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 16 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Does not live withing commuting distance

- Mental retardation

Study Design

Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Behavioral:
psychotherapy


Locations

Country Name City State
United States WPIC Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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