Online Treatments for Mood and Anxiety Disorders in Primary Care

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.

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.