Online Treatments for Mood and Anxiety Disorders in Primary Care
Condition: Depression; Generalized Anxiety Disorder; Panic Disorder
MeSH terms: Depression; Anxiety Disorders; Panic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): CCBT+ISG/Collaborative Care; CCBT/Collaborative Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Anxiety; Primary care; Cognitive Behavioral Therapy; Internet; Support groups; Technology assisted