Brief CBT for the Treatment of Depression During Inpatient Hospitalization
Primary Purpose
Depression
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Standard of Care
Cognitive Behavioral Therapy Condition (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Cognitive Behavioral Therapy (CBT)
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Condition
CBT Condition
Arm Description
usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.
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.
Outcomes
Primary Outcome Measures
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.
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.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03011619
Brief Title
Brief CBT for the Treatment of Depression During Inpatient Hospitalization
Official Title
Brief CBT for the Treatment of Depression During Inpatient Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
April 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Cognitive Behavioral Therapy (CBT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Condition
Arm Type
Active Comparator
Arm Description
usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.
Arm Title
CBT Condition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Standard of Care
Intervention Description
medication management, group therapy, and individual therapy.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy Condition (CBT)
Intervention Description
CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
Primary Outcome Measure Information:
Title
Montgomery-Ashberg Depression Scale (MADRS)
Description
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.
Time Frame
15 Minutes
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
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.
Time Frame
20 Minutes
Title
Clinical Global Impression Severity Scale (CGI-S)
Description
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)
Time Frame
20 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Sergie, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief CBT for the Treatment of Depression During Inpatient Hospitalization
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