Online Treatments for Mood and Anxiety Disorders in Primary Care

August 3, 2020 updated by: Bruce Rollman, University of Pittsburgh
Depression and anxiety are common in primary care practice and are associated with substantial reductions in health-related quality of life. This Project will test the comparative effectiveness of two on-line treatments for these conditions provided through the context of a Collaborative Care program: (1) moderated access to a proven-effective computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of these treatments to PCPs' "usual care" for these conditions, and evaluate the adoption and maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a greater understanding of how to best scale the delivery of these interventions into a variety of primary care settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression and anxiety are prevalent in primary care practice, associated with substantial reductions in health-related quality of life (HRQoL), and generate a significant excess of morbidity. In response, dozens of trials have demonstrated the greater effectiveness of "Collaborative Care" for these conditions vs. primary care physicians' usual care. Yet for a variety of reasons, these models have not been widely implemented. Therefore, an urgent need remains to develop and test more scalable, powerful, and innovative versions of Collaborative Care while simultaneously developing a greater understanding of how best to provide these interventions through primary care where the majority of depressed and anxious patients seek treatment.

Thousands of web sites provide medical information and the number of Internet support groups (ISG) where the public can exchange information about treatments is proliferating. Still, clinical trials have not established the benefits of utilizing the Internet in this manner. Concurrent with these developments, several computerized cognitive behavioral therapy (CCBT) programs have been proven effective at treating patients with mood and anxiety disorders and used by hundreds of thousands of patients outside the U.S. Yet CCBT remains little utilized inside the U.S., and no trials have incorporated CCBT into a Collaborative Care intervention or examined the effectiveness of combining CCBT with an ISG for these disorders.

We propose a 4-year comparative effectiveness trial that will randomize 700 primary care patients aged 18-75 who have at least a moderate level of mood and/or anxiety symptoms and reliable access to both the Internet and e-mail to either: (1) guided patient access to Beating the Blues, a proven-effective on-line CCBT program (CCBT-alone; N=300); (2) guided patient access to Beating the Blues plus access to a moderated ISG (CCBT+ISG; N=300); or (3) their PCP's "usual care" (N=100). Our primary hypothesis is that patients in our CCBT+ISG arm will report a clinically meaningful 0.30 effect size (ES) or greater improvement in HRQoL on the SF-12 MCS compared to patients in our CCBT-alone arm at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions. Our secondary hypothesis is that CCBT-alone patients will report a 0.50 ES or greater improvement in HRQoL on the SF-12 MCS versus "usual care" at 6-months follow-up. To better understand how online mental health treatments are best provided through primary care, we will also evaluate: (a) their effectiveness across and within age strata; (b) their cost-effectiveness; (c) how patients utilize the components of our interventions; (d) patient subgroups for whom our interventions may be particularly effective; and (e) the adoption and maintenance of our interventions by practices following the Intervention Phase of the Project. Study findings are likely to have profound implications for transforming the way mental health conditions are treated in primary care and focus further attention to the emerging field of e-mental health by other U.S. investigators.

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 2
  • Phase 3

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-75 Years of age.
  • Current major depression, panic, and/or generalized anxiety disorder on PRIME-MD.
  • At least a moderate level of mood and/or anxiety symptoms (PHQ-9 ≥ 10 or a GAD-7 ≥ 10).
  • Not receiving treatment for a mood or anxiety disorder from a mental health specialist.
  • Has a telephone, e-mail address, and reliable access to the Internet.
  • Stable medical condition and life expectancy greater than one year.

Exclusion Criteria:

  • Active suicidal ideation or psychotic disorder.
  • History of bipolar disorder.
  • Alcohol dependence or other substance abuse disorder within the past three months.
  • Plans to leave present source of care over the following year.
  • Non-English speaking, illiterate, or having a visual or auditory barrier limiting ability to participate in telephone assessments, interventions, or provide signed, informed consent.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computerized CBT + Internet Support Group
Guided patient access to Beating the Blues plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants (CCBT+ISG; N=300).
Behavioral: CCBT+ISG/Collaborative Care

Guided patient access to the Beating the Blues CCBT program plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants

These interventions will be delivered as part of a collaborative care intervention provided in concert with their usual source of primary care.

Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.
Experimental: Computerized CBT Alone
Guided patient access to Beating the Blues, a proven-effective, on-line 8-session CCBT program approved for use in the United Kingdom (CCBT-alone; N=300).
Behavioral: CCBT/Collaborative Care

Guided patient access to the Beating the Blues CCBT program.

This interventions will be provided as part of a collaborative care intervention provided in concert with their usual source of primary care.

Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.
No Intervention: Usual Care
Primary care physicians' "usual care" for mood and anxiety disorders (UC; N=100).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-12 MCS
Time Frame: 6-Month Follow-up
The investigators will assess all study patients' mental health-related quality of life (HRQoL) on the SF-12 MCS via telephone at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions.
6-Month Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression
Time Frame: 6-Months
The investigators will assess all study patients' mood symptoms using the HRS-D via telephone at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions.
6-Months
Hamilton Rating Scale for Anxiety
Time Frame: 6-Months
6-Months
WHO Health and Work Performance Questionnaire
Time Frame: 6-Months
6-Months
Health Services Utilization and Costs
Time Frame: 12-Months
12-Months
Attitudes to Computerized CBT
Time Frame: 6-Months
6-Months
Computerized CBT and Internet Support Group Usage
Time Frame: 12-Months
12-Months

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Bruce L. Rollman, MD, MPH, University of Pittsburgh

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

Helpful Links

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

February 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH093501 (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.

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