Brief CBT for the Treatment of Depression During Inpatient Hospitalization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-06

Study Completion Date

2018-04-05

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Condition

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

Group Type ACTIVE_COMPARATOR

Usual Standard of Care

Intervention Type BEHAVIORAL

medication management, group therapy, and individual therapy.

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.

Group Type EXPERIMENTAL

Usual Standard of Care

Intervention Type BEHAVIORAL

medication management, group therapy, and individual therapy.

Cognitive Behavioral Therapy Condition (CBT)

Intervention Type BEHAVIORAL

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

Interventions

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Usual Standard of Care

medication management, group therapy, and individual therapy.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No