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Brief Inpatient Psychotherapy for Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive factors
Behavioral factors
Increase engagement of pleasant events
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Psychological Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cognitive behavioral therapy

Behavioral Activation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Depressive Symptom Severity
The PHQ-9 is used to measure depressive symptoms

Secondary Outcome Measures

Functioning
WHODAS is used to measure functioning
Overall Health and Quality of life (QOL)
NIH-PROMIS-10 is used to measure the overall health and QOL

Full Information

First Posted
March 21, 2017
Last Updated
September 26, 2018
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03091582
Brief Title
Brief Inpatient Psychotherapy for Depression
Official Title
Pilot Testing of a Rapid-Onset Psychological Therapy Intervention for Depressed Medical Inpatients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
First Visit (after Identification by PHQ Intake Score): If, 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 subject will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions. These sessions will be provided subsequently by an attending psychiatrist or health psychologist in Psychiatry (currently Drs. IsHak, Danovitch, Hedrick, Chaudhry, and Sumner). Study Visits #'s 2 - 5: Details about the four therapy sessions are listed below. Study Participants will participate in therapy in the hospital room, with no other staff or patients present. Family and friends will not be allowed to be present. If nurses need to enter the room during the therapy session, therapy will be temporarily suspended. The treating clinician will choose a time for therapy that minimizes interruption by examining the patient's schedule and consulting with the attending psychiatrist. At the end of Visit #5, the study participant will also be offered a referral, by the attending psychiatrist or health psychologist, to a community-based therapist who is not affiliated with CSMC, and if the subject decides to participate, to continue therapy after discharge. The community-based therapist may or may not utilize the same approach utilized during the study. Community-based therapists will be selected among those who are known in the community to the treating psychiatrist/health psychologist, for whom the treating psychiatrist/psychologist can personally vouch. The treating psychiatrist/psychologist may select a community-based therapist whom the patient can afford, or is covered by the patient's insurance. Study participants and therapist will work together to select a community-based provider for use after discharge. The community-based therapy is not part of the research study and, therefore, subjects will be told that seeking this additional therapy is up to the subject and any potential costs related to these sessions will be covered by the subject and/or their insurance company. In the event of early discharge based on medical reasons, the therapy will be concluded and the patient will be referred to the community-based therapist. This will be considered an incomplete delivery of the sessions (early withdrawal). Treatments Both treatments will consist of four sessions during inpatient hospitalization. Cognitive Behavioral Therapy (CBT) Session one = Will last 1.5 hours and focus on depression psychoeducation, orient the study participant to brief CBT, treatment goal settings, and identification of maladaptive thoughts and beliefs. Solicit participant feedback and set agenda. Homework includes patient identifying automatic thoughts and core beliefs and associated emotions. Support and encouragement will be provided. Session two = Will last 50 min and will review homework, introduce cognitive strategies to test the accuracy of those beliefs by identifying and modifying negative thoughts and beliefs that give rise to them. Teach and practice identifying ruminative and catastrophizing thoughts. Will also review cognitive distortions and provide support and encouragement. Homework includes participants identifying ruminative and catastrophizing thoughts and challenging those thoughts. Will also teach relaxation techniques (e.g. deep breathing, guided imagery). Support and encouragement will be provided. Session three = Will last 50min and focus on reviewing homework, monitoring moods and activities, planning of exercises to test negative beliefs, and thought records to identify and examine the accuracy of negative automatic thoughts and underlying beliefs. Teach problem-solving skills Provide support and encouragement. Session four = Will last 50 minutes and focus on reviewing and consolidating newly learning cognitive strategies. Practicing. Generate plan for change and provide support and encouragement. Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) Session one = Will last 1.5 hours of depression psychoeducation (recognition of depression), treatment rationale, assessment of baseline activity level. Identification of factors that contribute to or exacerbate depressive behavior (e.g. withdrawal from friends or family), activity and goal selection, assessment of daily activities and environmental support prior to hospitalization, identification of pleasurable activities in which engaged (could be making a telephone call, journaling, reading, coloring, or if medically stable, having a plaza visit) and homework assignment (reporting a numerical rating of both enjoyment and importance for each activity identified). Provide support and encouragement. Session two = Will last 50 min and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Homework will be to chart progress of activity engagement by duration, frequency, self-reported level of mastery. Provide support and encouragement. Session three =Will last 50 min. Session will include a review of engagement in 3-5 activities considered rewarding and important for values. Discussion of how to continue activities, monitor depressive symptoms and identify rewards for activity engagement. Provide support and encouragement. Session Four = 50 minutes. Will review progress, provide support and encouragement and plan for continued engagement post-discharge. Provide support and encouragement. Study Visit #6 - Discharge: Before discharge, participants will complete three questionnaires administered by study staff, as follows: 1) a paper version of the PHQ-9 depression inventory, to assess depressive symptoms; 2) the National Institute of Health Patient Reported Outcome Measurement Information System (NIH PROMIS) 10-item Global Health scale, to assess QOL (PROMIS-10); and 3) the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, to assess functioning. These measures will serve as a baseline for comparison with data obtained 90 days later. Participants will also be asked whether they agree to be contacted in 90 days for follow-up assessment; those who agree will be contacted by study staff for Visit #7. Study Visit #7 - After Discharge: 90 days after the study participant is discharged from the hospital, study staff will contact the subject by phone to inquire about whether they utilized the referral to community-based therapy or not; those who did use the referral will be asked the number of sessions completed over the last 90 days, and the frequency of those sessions. In addition, study staff will also ask whether the subject started antidepressant medication after they left the hospital. If so, they will be asked what the medication and dosage was and how much of the medication they took and (assuming a 30-day dosage), how many pills they have left from the current bottle and when this bottle was prescribed. Any mental health issues that arise during this phone call will be referred to the original attending psychiatrist, or to the community-based therapist if the study participant chose to utilize the referral. Next, the staff member will ask if the study participant is interested in completing study measures over the phone, or on paper. If the subject agrees, the study staff member will administer the same three questionnaires given before discharge over the phone, taking approximately 30 minutes. If the subject prefers to complete these on paper, questionnaires will be mailed by US postal mail along with a self-addressed stamped envelope, and the phone call will end after 5 minutes. These data will be collected and de-identified for analysis. 4 Anticipated Level of Risk:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Psychological Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral Activation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive factors
Intervention Description
The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress
Intervention Type
Behavioral
Intervention Name(s)
Behavioral factors
Intervention Description
The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress.
Intervention Type
Behavioral
Intervention Name(s)
Increase engagement of pleasant events
Intervention Description
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 Measure Information:
Title
Depressive Symptom Severity
Description
The PHQ-9 is used to measure depressive symptoms
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Functioning
Description
WHODAS is used to measure functioning
Time Frame
12 weeks
Title
Overall Health and Quality of life (QOL)
Description
NIH-PROMIS-10 is used to measure the overall health and QOL
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waguih W IsHak, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brief Inpatient Psychotherapy for Depression

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