Online Treatments for Mood and Anxiety Disorders in Primary Care

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bruce Rollman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01482806
First received: November 22, 2011
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Depression
Generalized Anxiety Disorder
Panic Disorder
Behavioral: CCBT+ISG/Collaborative Care
Behavioral: CCBT/Collaborative Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Online Treatments for Mood and Anxiety Disorders in Primary Care

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • SF-12 MCS [ Time Frame: 6-Month Follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: 6-Months ] [ Designated as safety issue: No ]
    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.

  • Hamilton Rating Scale for Anxiety [ Time Frame: 6-Months ] [ Designated as safety issue: No ]
  • WHO Health and Work Performance Questionnaire [ Time Frame: 6-Months ] [ Designated as safety issue: No ]
  • Health Services Utilization and Costs [ Time Frame: 12-Months ] [ Designated as safety issue: No ]
  • Attitudes to Computerized CBT [ Time Frame: 6-Months ] [ Designated as safety issue: No ]
  • Computerized CBT and Internet Support Group Usage [ Time Frame: 12-Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482806

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Bruce L. Rollman, MD, MPH University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Bruce Rollman, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01482806     History of Changes
Other Study ID Numbers: R01 MH093501, 1 R01 MH093501-01A1
Study First Received: November 22, 2011
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Depression
Anxiety
Primary care
Cognitive Behavioral Therapy
Internet
Support groups
Technology assisted

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

ClinicalTrials.gov processed this record on April 15, 2014