Brief CBT for the Treatment of Depression During Inpatient Hospitalization

Depression Clinical Trial

Official title:

Brief CBT for the Treatment of Depression During Inpatient Hospitalization

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03011619
• Other study ID #: 16-01404
• Status: Withdrawn
• Phase: N/A
• Start date: April 6, 2017
• Est. completion date: April 5, 2018

Study information

• Verified date: March 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 5, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Usual Standard of Care
medication management, group therapy, and individual therapy.
• Cognitive Behavioral Therapy Condition (CBT)
CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Ashberg Depression Scale (MADRS)	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.	15 Minutes
Primary	Hamilton Rating Scale for Depression (HAM-D)	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.	20 Minutes
Primary	Clinical Global Impression Severity Scale (CGI-S)	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)	20 Minutes