An interventional study of Beating the Blues in Major Depressive Disorder, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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 a 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 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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 128 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Beating the Blues plus helper support.
Behavioral: Beating the Blues
Eight week waitlist condition group parallel to the immediate treatment condition with optional entrance into the Beating the Blues after the first eight weeks
The BtB program guides patients through a series of 8 fully automated online lessons intended to help them identify and change problematic patterns of thinking and behavior that maintain depression. Support will be provided by licensed professional therapists over the phone or via email.
Also known as: Beating the Blues (BtB)
Change in Hamilton Rating Scale for Depression (HRSD) from 0 to 8 weeks
The 17-item HRSD, modified to assess atypical symptoms, is a standard interview-administered measure of depressive symptom severity. The HRSD will be administered by study personnel supervised by the Principal Investigator.
Time frame: week 0, week 8
Change in Patient Health Questionnaire-9 (PHQ9) over 8 weeks
The PHQ9 is a 9-item self-report measure based on the diagnostic criteria for major depression from the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Time frame: weeks 0-8
Change in Generalized Anxiety Disorder-7 (GAD7) over 8 weeks
The GAD7 is a 7-item self-report measure based on the diagnostic criteria for generalized anxiety disorder from the DSM-IV.
Time frame: weeks 0-8
Change in Depression Anxiety and Stress Scale-21 (DASS21) over 8 weeks
The DASS21 is a 21-item self-report scale measuring symptoms of depression, anxiety, and stress.
Time frame: week 0, week 8
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Ohio State University