Study of a Self-Help Depression Skills Program for College-Aged Youth

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00145054
Study type	Interventional
Source	Kaiser Permanente
Contact
Status	Completed
Phase	Phase 2/Phase 3

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.