MoodHelper: Internet Cognitive Behavioral Therapy (CBT) for Depression

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

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