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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00152529
Other study ID # 12591A
Secondary ID U48/CCU309674 -
Status Terminated
Phase N/A
First received September 7, 2005
Last updated September 4, 2013
Start date October 2003
Est. completion date June 2004

Study information

Verified date September 2013
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to adapt depression prevention interventions of proven benefit to the primary care setting in a manner that would be acceptable and potentially available to young adults in the community.


Description:

Our study goal is to develop a prototype combination primary care-web based depression intervention for young adults ages 18-24years in urban community and university settings. The content development will include: (1) two brief (15 minutes) primary care counseling sessions, (2) one introductory web based module, (3) four web-based cognitive behavior teaching modules, (4) three web-based modules discussing relationship building skills (IPT), and (5) a final web module discussing self-recognition, evidence-based treatment, and stigma. Eight young adult volunteers will evaluate the program in three loops of evaluation and revision in a modified focus group approach. This protocol was approved by the Johns Hopkins Joint Committee on Clinical Investigations.

Primary Outcomes:

The primary outcome variables relate to the functionality and acceptability of the intervention. These variables include readability, ease of understanding, acceptability, and helpfulness of each component of the intervention, and a global rating of each

Secondary Outcomes:

Process measures (time on site, exercise completion), outcomes (mood and intermediate outcomes-social adjustment, dysfunctional thinking), and knowledge and opinions of current treatments for depression. These data will be helpful in planning for a future Focus groups of 5-10 individuals have been used successfully to provide initial product evaluations or to develop general themes in attitude research. Summary statistics will be collected.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date June 2004
Est. primary completion date June 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Eligibility criteria include being between ages 18-24 and having a family history of depression. Preference will be given in selection of participants to those of who have not been treated for depression in the past.

Exclusion Criteria:

- Moderate or greater risk of having depression (CESD score > 16) or current treatment for depression. Those who have a history of past treatment of depression will not be excluded.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Behavioral:
Screening (Behavior)


Locations

Country Name City State
United States The University of Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

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