MoodHelper: Internet Cognitive Behavioral Therapy (CBT) for Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01379027
First received: June 10, 2011
Last updated: January 30, 2014
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Depression
Behavioral: Pure self-help Internet CBT for depression
Behavioral: Guided self-help Internet CBT
Behavioral: Stepped-Care Internet CBT condition
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet CBT for Depression: Comparing Pure, Guided, and Stepped Care

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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. [ Time Frame: assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • secondary analyses will examine healthcare utilization for any signs of shifts in amount or mix of TAU services by study condition. [ Time Frame: assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment ] [ Designated as safety issue: No ]
    We will conduct cost-effectiveness analyses, examine TAU healthcare utilization from EMR, participant report and collect quantitative and qualitative data on patient, provider, and organizational factors that may impede or facilitate implementation of these interventions and we have added a non-research Reach Estimation Phase to better estimate acceptance and retention rates under conditions that closely match real-world dissemination


Estimated Enrollment: 1800
Study Start Date: October 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: a treatment as usual (TAU) control condition
Participants 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.
Experimental: Pure self-help Internet CBT for depression
Participants 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
Behavioral: Pure self-help Internet CBT for depression
Internet, CBT, Depression
Experimental: Guided self-help Internet CBT
Participants will receive TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists
Behavioral: Guided self-help Internet CBT
CBT, Depression, Website intervention, coaching
Experimental: Stepped-Care Internet CBT condition
This 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
Behavioral: Stepped-Care Internet CBT condition
Depression CBT, Internet intervention

Detailed Description:

Evidence-based treatments (EBTs) for depression are often not available to persons needing them; this is particularly true of psychotherapies. Even when available, EBTs are often poorly delivered at less-than-optimal quality. High direct and indirect costs also limit the availability of EBTs. Together these barriers contribute to suboptimal treatment of depression in the community. In a preliminary step toward addressing these quality shortcomings, the investigators propose to conduct a blended efficacy- effectiveness randomized controlled trial (RCT) of high fidelity, Internet-delivered cognitive behavioral therapy (CBT) for depression, extending our previous research to maximize treatment availability and quality as well as to reduce costs. Over a 36-month recruitment period, the investigators will enroll 1,800 adults seeking care for depression from 3 rural healthcare clinics, 3 safety net federally qualified healthcare centers (FQHCs), and 2 non-profit HMOs. Participants will be randomized to: (a) a treatment as usual (TAU) control condition, typically antidepressants and/or psychosocial services; (b) TAU plus Pure self-help Internet CBT for depression, consisting of access to the Internet site without any contact with therapists; (c) TAU plus Guided self-help Internet CBT, consisting of access to the Internet site plus brief, periodic telephone contacts with therapists; 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. 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. The investigators also expect secondary analyses to reveal this pattern of results: Guided CBT > Pure CBT > TAU. The investigators will conduct cost-effectiveness analyses (CEA), as the investigators project substantial differences in the direct costs of each study arm. The investigators will also examine TAU healthcare utilization (medications, visits, etc) from electronic medical records (EMR), billing systems, and participant report. The investigators hypothesize that cost per depression free days (DFDs) and quality- adjusted life years (QALYs) will be lowest for Pure CBT, relative to Guided and Stepped-Care CBT and TAU. The investigators also hypothesize that cost per unit of improvement in QALYs and DFDs will be better for Stepped-Care compared to Guided CBT. Additional aims include exploratory examination of secondary outcomes, and predictors and moderators of outcomes among the interventions. The investigators also will collect quantitative and qualitative data on patient, provider, and organizational factors that may impede or facilitate implementation of these interventions, to help prepare for future dissemination efforts. Finally, in this reapplication the investigators have added a non-research Reach Estimation Phase to better estimate acceptance and retention rates under conditions that closely match real-world dissemination

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379027

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Oregon Health and Science University
Investigators
Principal Investigator: Greg N Clarke, PhD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01379027     History of Changes
Other Study ID Numbers: 1R01 MH087505
Study First Received: June 10, 2011
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Depression
Website intervention
CBT

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

ClinicalTrials.gov processed this record on October 22, 2014