MoodHelper: Internet Cognitive Behavioral Therapy (CBT) for Depression

March 6, 2018 updated by: Kaiser Permanente

Internet CBT for Depression: Comparing Pure, Guided, and Stepped Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1816

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
assessment measure is administered at baseline and each follow-up, at 5, 10, 15, 25, and 50 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Oregon Health and Science University

Investigators

  • Principal Investigator: Greg N Clarke, PhD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH087505 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Pure self-help Internet CBT for depression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe