MoodHelper: Internet Cognitive Behavioral Therapy (CBT) for Depression
Internet CBT for Depression: Comparing Pure, Guided, and Stepped Care
1 other identifier
interventional
1,816
1 country
1
Brief Summary
Evidence-based treatments (EBTs) for mental health conditions are often not available to persons needing them in the community. Our aim is to test a novel Internet intervention that has the promise of eventually improving the Reach and Implementation of mental health EBTs, speeding the translation of research successes into improved community care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Oct 2011
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 8, 2018
March 1, 2018
4.8 years
June 10, 2011
March 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary hypothesis for which the study is powered is that Guided self-help CBT will result in greater depression symptom improvement than Pure self-help CBT.
We'll enroll 1,800 adults with depression from 3 rural healthcare clinics, 3 safety net federally qualified healthcare centers and 2 non-profit HMO. Participants will be randomized to: TAU only (b) TAU plus Pure self-help Internet CBT for depression (G-CBT), (c) TAU plus G-CBT, plus brief, periodic therapist telephone contacts; or (d) a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on. Participants will be followed for one year.
assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment
Secondary Outcomes (1)
secondary analyses will examine healthcare utilization for any signs of shifts in amount or mix of TAU services by study condition.
assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment
Study Arms (4)
a treatment as usual (TAU) control condition
NO INTERVENTIONParticipants will receive recruitment information, go on the study website to enroll and complete assessments over the study web site but will not receive the study intervention.
Pure self-help Internet CBT for depression
EXPERIMENTALParticipants will receive TAU plus access to the study website for the self-help Internet CBT for depression, consisting of access to the Internet site without any contact with therapist
Guided self-help Internet CBT
EXPERIMENTALParticipants will receive TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists
Stepped-Care Internet CBT condition
EXPERIMENTALThis consists of a Stepped-Care Internet CBT condition, starting with TAU + Pure self-help CBT and progressing to Guided self-help CBT if adequate progress is not observed early on
Interventions
Internet, CBT, Depression
CBT, Depression, Website intervention, coaching
Depression CBT, Internet intervention
Eligibility Criteria
You may qualify if:
- Participants must have a score ≥ 10 on the self-report Patient Health Questionnaire (PHQ-8), indicative of clinically significant, moderate depression.
- Participants must identify their primary healthcare provider in one of the 8 performance sites, and give permission to contact him or her for the purpose of periodic progress reports as well as a referral contact in case any emergent crises are detected.
- Participant must be 18 years of age have access to a computer with internet and a working email address.
- Participants must also indicate they are planning to continue receiving services from one of the performance site clinics/organizations for at least the next 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaiser Permanentelead
- Oregon Health and Science Universitycollaborator
Study Sites (1)
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227, United States
Related Publications (1)
Sheppler CR, Edelmann AC, Firemark AJ, Sugar CA, Lynch FL, Dickerson JF, Miranda JM, Clarke GN, Asarnow JR. Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106959. doi: 10.1016/j.cct.2022.106959. Epub 2022 Oct 11.
PMID: 36228984DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Greg N Clarke, PhD
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 23, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
March 8, 2018
Record last verified: 2018-03