- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00145054
Study of a Self-Help Depression Skills Program for College-Aged Youth
March 23, 2006 updated by: Kaiser Permanente
Randomized, Controlled Pilot Study of a Self-Help Depression Skills Program for College-Aged Youth
We propose to conduct a pilot trial of an Internet-only depression skills training program for adolescents and young adults.
The intervention, MoodHelper.org already exists and has been tested in two pilots.
In this third pilot, we plan to use an enriched minority sampling frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a enrollment target of 150.
Interested members will go to the study Internet site, and if they choose to participate, complete the online consent and assessment battery (used in the previous pilots).
Participants will be randomly assigned by the site's software to one of two conditions: (1) the "Intervention" condition, with complete access to the SADhelper.org
web site or (2) the "Usual Care" condition, with access to all Internet sites and KPNW health care, but with no access to the therapeutic portion of the SADhelper site.
All participants (those with and without access to the research intervention) will be reminded by e-mail and, if necessary, by telephone to return to the web site and complete follow-up questionnaires four, eight, sixteen, and thirty-two weeks after enrolling in the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We propose to conduct a pilot trial of an Internet-only depression skills training program for adolescents and young adults.
The intervention, MoodHelper.org already exists and has been tested in two pilots.
In this third pilot, we plan to use an enriched minority sampling frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a enrollment target of 150.
Interested members will go to the study Internet site, and if they choose to participate, complete the online consent and assessment battery (used in the previous pilots).
Participants will be randomly assigned by the site's software to one of two conditions: (1) the "Intervention" condition, with complete access to the SADhelper.org
web site or (2) the "Usual Care" condition, with access to all Internet sites and KPNW health care, but with no access to the therapeutic portion of the SADhelper site.
All participants (those with and without access to the research intervention) will be reminded by e-mail and, if necessary, by telephone to return to the web site and complete follow-up questionnaires four, eight, sixteen, and thirty-two weeks after enrolling in the study.
Study Type
Interventional
Enrollment
150
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oregon
-
Portland, Oregon, United States, 97227
- Kaiser Permanente Center for Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
current clinical diagnosis of depression Internet access
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
self-reported depression on the CES-D
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
health care utilization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Greg Clarke, Ph.D., Kaiser Permanente
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Estimate)
March 24, 2006
Last Update Submitted That Met QC Criteria
March 23, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R24MH061422 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.