Clinical trial NCT00145054: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

current clinical diagnosis of depression Internet access

Exclusion Criteria:

none

Primary outcomes:
measure: self-reported depression on the CES-D
Secondary outcomes:
measure: health care utilization
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Greg Clarke, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.