Expired Study
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Portland, Oregon 97227


Purpose:

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 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.


Criteria:

Inclusion Criteria: current clinical diagnosis of depression Internet access Exclusion Criteria: none


Study is Available At:


Original ID:

R24 MH61422


NCT ID:

NCT00145054


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Randomized, Controlled Pilot Study of a Self-Help Depression Skills Program for College-Aged Youth


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

14 Years


Maximum Age:

24 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Kaiser Permanente


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:


Overall Contact Information

Official Name:Greg Clarke, Ph.D.
Principal Investigator
Kaiser Permanente

Study Dates

Verification Date:September 2005
Last Changed Date:March 23, 2006
First Received Date:September 1, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:health care utilization
Safety Issues:False
Outcome Type:Primary Outcome
Measure:self-reported depression on the CES-D
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:MoodHelper Internet program for Depression Self-He

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Kaiser Permanente

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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