Pilot Study Assessing Computerized Cognitive Behavioral Therapy for Depression

Currently, outpatient psychiatric settings are plagued by long wait times and are often
unable to accommodate all individuals seeking services. Furthermore, a lack of trained
therapists in these settings means that many treatment seekers do not have access to
empirically supported psychotherapeutic treatments such as cognitive behavioral therapy.
"Beating the Blues" (BtB) is a computerized, internet-delivered, cognitive behavioral
treatment for depression. BtB is highly scalable and might enable a larger proportion of
individuals to receive cognitive behavioral therapy in a psychiatric setting while also
reducing therapist time. Although computerized CBT interventions have proven effective in
primary care settings, there is no research demonstrating the effectiveness of cCBT in
secondary care settings in the United States. Thus the primary goal of the proposed research
is to test the efficacy of BtB in a specialty care sample.

Patients presenting to these settings tend to have more severe and complex psychopathology
than those presenting to primary care. Although BtB is likely effective, computerized
treatments do carry a higher risk of dropout and non-response. Therefore, reliable and valid
predictors of response are needed to determine who is most likely to respond to the
treatment, versus who is likely to fail or drop out. Thus the second aim of the current
proposal is to pilot an assessment procedure containing a number of potential predictors of
cCBT response and investigate these predictors for inclusion in a larger validation study.

The current trial is a pilot study with a randomized waitlist control design with optional
delayed treatment for individuals randomized to the waitlist condition. For the first phase,
the investigators will enroll 90 treatment-seeking adults 18 or older recruited from a pool
of individuals seeking outpatient psychiatric services at a hospital clinic. Sixty (n=60)
individuals will be assigned immediate treatment group with BtB plus telephone and email
support, and n=30 to the waitlist/delayed BtB plus telephone and email support group.
Efficacy will be assessed over 8 weeks using the Hamilton Rating Scale for Depression (pre to
post treatment) and the PHQ9 (measured at weeks 1-8). There will also be a 1-year follow-up
survey with biweekly symptom assessments throughout the year for treatment responders (weeks
9-61). Potential predictors of outcome include demographics, CBT skills, personality
measures, cognitive functioning, measures of attitudes and beliefs, social functioning,
psychiatric comorbidity and depression illness characteristics, and psychophysiological
measures. A second phase will enroll sixty individuals (n=60), who will be assigned immediate
treatment group in order to validate the predictive model constructed during Phase 1.

Inclusion Criteria:

- Diagnosis of Major Depressive Disorder (MDD) according to Diagnostic and Statistical
Manual Fourth Edition criteria

- Able and willing to give informed consent

- Have access to a computer with an internet connection at home

Exclusion Criteria:

- History of bipolar affective disorder or psychosis

- Current Axis I disorder other than MDD if it constitutes the predominate aspect of the
clinical presentation and if it requires treatment other than that being offered

- History of substance dependence in the past six months

- Subnormal intellectual potential (IQ below 80)

- Clear indication of secondary gain (e.g., court ordered treatment or compensation
issues)

- Current suicide risk or significant intentional self-harm in the last six months
sufficient to preclude treatment on an outpatient basis

- Discharge within six moths from a higher level of care (inpatient, partial hospital,
or intensive outpatient treatment)

- Currently undergoing outpatient psychotherapy

- Current antidepressant medication treatment if the individual has had a change in
medication over the past month or is planning a change in medication during the
duration of the study

- Inability to read and write English