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临床试验/NCT03091582
NCT03091582已完成不适用

Pilot Testing of a Rapid-Onset Psychological Therapy Intervention for Depressed Medical Inpatients

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Depressive Symptom Severity

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Cognitive behavioral therapy

Experimental

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.

干预措施: Cognitive factors (Behavioral)

Cognitive behavioral therapy

Experimental

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.

干预措施: Behavioral factors (Behavioral)

Behavioral Activation

Experimental

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.

干预措施: Increase engagement of pleasant events (Behavioral)

结局指标

主要结局

Depressive Symptom Severity

时间窗: 12 weeks

The PHQ-9 is used to measure depressive symptoms

次要结局

  • Functioning(12 weeks)
  • Overall Health and Quality of life (QOL)(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Waguih IsHak

Vice Chairman for Education & Research Cedars-Sinai Medical Center

Cedars-Sinai Medical Center

研究点 (2)

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