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Friday, October 24, 2014 2:25:11 PM

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BtB Clinical Gov Trials April 2014 to April 2015.

Standard treatments for depression in specialty care settings are effective but resources for delivering empirically supported psychotherapies are often limited. Computerized cognitive behavioral therapy (cCBT) is an effective and highly scalable treatment for depression that might help expand services in psychiatric settings, however, little is known about its efficacy in this population.

The present study aims to establish the efficacy of an internet-delivered cCBT program ("Beating the Blues") plus email and telephone support for depression in a psychiatric outpatient clinic setting. The secondary aim is to pilot an assessment procedure designed to identify moderators of treatment effectiveness.

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 is 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. We 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 wait list 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, 3, 5 and 8). There will also be a 1-month follow-up. 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.

ClinicalTrials.gov processed this data on October 16, 2014 ...

clinicaltrials.gov/show/NCT01990053?displayxml=true
Computerized cognitive behavioral therapy (cCBT) is an effective and highly ... the efficacy of a internet-delivered cCBT program ("Beating the Blues") plus email and ... Recruiting April 2014 April 2015 April 2015 N/A Interventional Allocation: ...
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