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Brief Inpatient Psychotherapy for Depression

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ClinicalTrials.gov Identifier: NCT03091582
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Waguih IsHak, Cedars-Sinai Medical Center

Brief Summary:
The primary objective of the proposed pilot study is to seek to compare the efficacy of two brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for improving depressive symptoms, functioning, and quality of life (QOL). The treatments will consist of four sessions, which will be delivered during hospitalization.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive factors Behavioral: Behavioral factors Behavioral: Increase engagement of pleasant events Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the patient will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Testing of a Rapid-Onset Psychological Therapy Intervention for Depressed Medical Inpatients
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive behavioral therapy
The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive factors and behavioral factors on affective distress.
Behavioral: Cognitive factors
The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress

Behavioral: Behavioral factors
The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress.

Experimental: Behavioral Activation
Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events.
Behavioral: Increase engagement of pleasant events
Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events.




Primary Outcome Measures :
  1. Depressive Symptom Severity [ Time Frame: 12 weeks ]
    The PHQ-9 is used to measure depressive symptoms


Secondary Outcome Measures :
  1. Functioning [ Time Frame: 12 weeks ]
    WHODAS is used to measure functioning

  2. Overall Health and Quality of life (QOL) [ Time Frame: 12 weeks ]
    NIH-PROMIS-10 is used to measure the overall health and QOL



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Adults from 18-80; 2) PHQ>12; 3) Medical conditions needing inpatient medical care.

Exclusion Criteria:

  • 1) Patients who unable to provide informed consent; 2) Patients deemed in critical medical condition; 3) Conditions that preclude administration of the PHQ for depression screening (e.g., delirium, dementia, acute stroke, loss of consciousness, substance intoxication or withdrawal, agitation, psychotic disorders); 4) Homeless patients, as patient follow-up by mail would be difficult; 5) Meeting criteria for involuntary admission due to imminent danger to self or others, as they are transferred to offsite psychiatric facilities.

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): NCT03091582


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Waguih W IsHak, MD Cedars-Sinai Medical Center

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Responsible Party: Waguih IsHak, Vice Chairman for Education & Research Cedars-Sinai Medical Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03091582     History of Changes
Other Study ID Numbers: Pro00046076
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Waguih IsHak, Cedars-Sinai Medical Center:
Psychological Therapy

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