Participants assigned to the CBT condition will receive the usual standard of care during an inpatient psychiatric hospitalization. This includes but is not limited to medication management, group therapy, and individual therapy. If a patient is randomly assigned to the enhanced CBT group, manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries. The training M.D., who is a treating physician on HCC-10, will also intermittently and randomly observe the CBT sessions to ensure the manual properly is being followed. Although the control condition may contain elements of CBT as per the clinician completing the therapy, it is not manualized, does not include specific exercises to be completed between sessions, and is not a course that builds upon skills from the previous day, as in the CBT condition.
Participants in this study are already receiving standard-of-care treatment in an inpatient psychiatric hospital setting, including, but not limited to, medication management, group therapy, and individual therapy. Patients are randomly assigned to an enhanced CBT group through manualized CBT. The study includes a series of sessions built upon prior sessions, planned exercises, workouts, and journal entries. The training MD is a treating physician on HCC-10. The physician observes the CBT sessions to ensure the manual is properly followed. The control condition contains CBT, is not manualized, and does not include specific exercises or built on therapies from the previous day.
Participants of the controlled condition receive normal standard-of-care treatment including medical management, group therapy, and individual therapy. In addition to standard care, they are placed in a controlled CBT group enhanced by methods within the study. A trained MD oversees the enhanced CBT. The control condition contains CBT elements but is not manualized. It also does not include specific exercises to be completed between sessions and is not designed as a course that builds upon skills from the previous day, as in typical CBT treatment.
The primary sole sponsor of this study is New York University School of Medicine.
Participants from all sexes are eligible if they are aged 18 or older. Participants are required to have a diagnosis of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria on initial assessment. Additionally, they must provide written consent and demonstrate a moderate degree of depressive symptoms on MAR-S, HAM-D, and CGI-S.
If the patient has a mental illness other than depression as the primary cause of treatment, as determined by the Principal Investigator, they cannot participate. A cognitive or neurological disorder that inhibits the ability to engage in CBT would also eliminate patients from the study.