Brief CBT for the Treatment of Depression During Inpatient Hospitalization

NCT03011619 | Withdrawn

• 1 other identifier: 16-01404
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

Depression; Cognitive Behavioral Therapy (CBT)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Control Condition

ACTIVE COMPARATOR

usual standard of care during an inpatient psychiatric hospitalization; medication management, group therapy, and individual therapy.

Behavioral: Usual Standard of Care

CBT Condition

EXPERIMENTAL

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; Behavioral: Cognitive Behavioral Therapy Condition (CBT)

Interventions

Usual Standard of Care BEHAVIORAL

medication management, group therapy, and individual therapy.

CBT Condition; Control Condition

Cognitive Behavioral Therapy Condition (CBT) BEHAVIORAL

CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.

CBT Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jacqueline Sergie, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: April 6, 2017
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

US (1)