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Brief CBT for the Treatment of Depression During Inpatient Hospitalization

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ClinicalTrials.gov Identifier: NCT03011619
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Depression Behavioral: Usual Standard of Care Behavioral: Cognitive Behavioral Therapy Condition (CBT) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief CBT for the Treatment of Depression During Inpatient Hospitalization
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Condition
usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.
Behavioral: Usual Standard of Care
medication management, group therapy, and individual therapy.

Experimental: CBT Condition
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.
Behavioral: Usual Standard of Care
medication management, group therapy, and individual therapy.

Behavioral: Cognitive Behavioral Therapy Condition (CBT)
CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.




Primary Outcome Measures :
  1. Montgomery-Ashberg Depression Scale (MADRS) [ Time Frame: 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.

  2. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 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.

  3. Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011619


Contacts
Contact: Yona Silverman (212) 263-7419 yona.silverman@nyumc.org
Contact: Allison Young (212) 263-7419 allison.young@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Yona Silverman       yona.silverman@nyumc.org   
Contact: Jacqueline Sergie       jacqueline.sergei@nyumc.org   
Principal Investigator: Jacqueline Sergie, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jacqueline Sergie, MD NYU School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03011619     History of Changes
Other Study ID Numbers: 16-01404
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Depression
Cognitive Behavioral Therapy (CBT)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders