Brief CBT for the Treatment of Depression During Inpatient Hospitalization

Not Applicable

Withdrawn

• Conditions: Depression
• Interventions: Behavioral: Usual Standard of Care; Behavioral: Cognitive Behavioral Therapy Condition (CBT)

• Registration Number: NCT03011619
• Lead Sponsor: NYU Langone Health

Brief Summary

Moderately to severely depressed subjects will be randomized to the "Control Group," who will receive care as usual, or the "CBT Group," who will receive care as usual in addition to the manualized course of Cognitive Behavioral Therapy (CBT).

Detailed Description

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 assigned to the control 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.

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Study Start: 2017-04-06
• Primary Completion: 2018-04-05
• Study Completion: 2018-04-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosed with depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria on initial assessment on the unit.
• Demonstrates at least moderate degree of depressive symptoms on MADRS, HAM-D, and CGI-S.
• Provides written informed consent.

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Exclusion Criteria

• A mental illness other than depression that is the primary cause of treatment, as determined by the Principal Investigator.
• A cognitive or neurologic disorder that inhibits ability to engage in CBT.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT Condition	Usual Standard of Care	If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
Control Condition	Usual Standard of Care	usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.
CBT Condition	Cognitive Behavioral Therapy Condition (CBT)	If a patient is randomly assigned to the enhanced CBT group, they will participate in manualized CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.

Primary Outcome Measures

Name	Time	Method
Montgomery-Ashberg Depression Scale (MADRS)	15 Minutes	A ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. The ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe). It is designed to be sensitive to change, so is often the scale of choice when interventions, such as psychotherapies, electroconvulsive therapy, or drug trials, are being studied.
Hamilton Rating Scale for Depression (HAM-D)	20 Minutes	Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness.
Clinical Global Impression Severity Scale (CGI-S)	20 Minutes	Single-item rating scale of the clinician's assessment of the global severity of depressive symptoms in relation to the clinician's total experience with depressed patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States