Pilot Testing of a Rapid-Onset Psychological Therapy Intervention for Depressed Medical Inpatients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Depressive Symptom Severity
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults from 18-80; 2) PHQ>12; 3) Medical conditions needing inpatient medical care.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Cognitive factors (Behavioral)
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.
Intervention: Behavioral factors (Behavioral)
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.
Intervention: Increase engagement of pleasant events (Behavioral)
Outcomes
Primary Outcomes
Depressive Symptom Severity
Time Frame: 12 weeks
The PHQ-9 is used to measure depressive symptoms
Secondary Outcomes
- Functioning(12 weeks)
- Overall Health and Quality of life (QOL)(12 weeks)
Investigators
Waguih IsHak
Vice Chairman for Education & Research Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
