Study of a Self-Help Depression Skills Program for College-Aged Youth
Primary Purpose
Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MoodHelper Internet program for Depression Self-Help
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: current clinical diagnosis of depression Internet access Exclusion Criteria: none
Sites / Locations
- Kaiser Permanente Center for Health Research
Outcomes
Primary Outcome Measures
self-reported depression on the CES-D
Secondary Outcome Measures
health care utilization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00145054
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kaiser Permanente
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
MoodHelper Internet program for Depression Self-Help
Primary Outcome Measure Information:
Title
self-reported depression on the CES-D
Secondary Outcome Measure Information:
Title
health care utilization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
current clinical diagnosis of depression Internet access
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Clarke, Ph.D.
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19440896
Citation
Clarke G, Kelleher C, Hornbrook M, Debar L, Dickerson J, Gullion C. Randomized effectiveness trial of an Internet, pure self-help, cognitive behavioral intervention for depressive symptoms in young adults. Cogn Behav Ther. 2009;38(4):222-34. doi: 10.1080/16506070802675353.
Results Reference
derived
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Study of a Self-Help Depression Skills Program for College-Aged Youth
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