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

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ClinicalTrials.gov Identifier: NCT00145054
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : March 24, 2006
Sponsor:
Information provided by:
Kaiser Permanente

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: MoodHelper Internet program for Depression Self-Help Phase 2 Phase 3

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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Pilot Study of a Self-Help Depression Skills Program for College-Aged Youth

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. self-reported depression on the CES-D

Secondary Outcome Measures :
  1. health care utilization

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

current clinical diagnosis of depression Internet access

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145054


Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Greg Clarke, Ph.D. Kaiser Permanente
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00145054     History of Changes
Other Study ID Numbers: R24MH061422 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: March 24, 2006
Last Verified: September 2005

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders