跳至主要内容
临床试验/NCT04280614
NCT04280614已完成不适用

Day Hospital Treatment of Emotional Dysregulation: A Quantitative Analysis

University of Manitoba1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Self-harm, emotional distress, depression, anxiety

研究概览

简要总结

Objective: The goal of this proposed research project is a quantitative analysis of a day hospital program designed to treat persons with emotional dysregulation.

Background: The Short-term Assessment and Treatment (STAT) program has been operating at Health Sciences Center, Winnipeg, Manitoba for many decades. The STAT program is based on the principles of dialectical and cognitive behavior therapy. The STAT program is a five week day hospital program employing multi-modal treatment methods to treat patients with emotional dysregulation. The literature provides evidence of numerous treatment models with varying effectiveness for this population of patients. The STAT program hasn't had a quantitative analysis of its treatment model.

Problem Statement: Is the 5 week day hospital treatment model developed and employed by the STAT program effective in improving the mental health of participants admitted to the program?

详细描述

Research on brief therapeutic interventions for those diagnosed with BPD have often involved a year or more of treatment in an outpatient, inpatient or partial hospitalization setting. The goal of this research proposal is to examine if a 5-week day hospital treatment program at a tertiary hospital within Shared Health can demonstrate effective amelioration of subject symptoms on a number of measures.

As noted in the introduction there is significant public health considerations associated with persons living with borderline personality disorder pathology. Evidence-based public health should be informed by practice-based evidence stemming from the rigorous evaluation of relevant natural experiments. Due to logistic and ethical considerations a randomized control trial isn't feasible. Given these considerations, the proposed research design is a naturalistic pre- post-intervention with no control group. Although causality cannot be determined in a naturalistic design, methodological rigour employed will mitigate the impact of outside variable from invalidating the results obtained from the proposed research. Participants data will be collected at two times and the data from the same individual will be compared focusing on differences between pre- and post-intervention. The benefit in the longitudinal design is the potential to control for temporal or secular changes observed in the outcome. A challenge in interpreting randomized control trials is potential biases that impact external validity and reduce the ability of the researchers to generalize the outcomes associated with an intervention. Naturalistic studies can reduce the impact of confounding variable by identifying and controlling potential variables, such as socio-economic factors.

Sample Characteristics and Selection Participants are referred to the STAT program through emergency room consultations, family physician referrals and from psychiatrists working in the community, outpatient department or during an inpatient admission. Participants are individuals 18 years and older.

Although participants in the STAT program are primarily females there is no exclusion criteria based on gender. These participants are assigned a therapist who will complete a psychiatric interview and review a self-report each participant is required to complete prior to the initial interview. Potential participants will meet with a psychiatrist to review the information gathered in the therapist interview and determine if the client will be admitted to the STAT day hospital program. Participants are accepted if they meet admission criteria as determined by the psychiatrist. Participants are excluded if they have a diagnosis of antisocial personality disorder, criminal charges, or significant substance abuse. Participants are required to formulate behaviour-oriented goals to work on while participating in the STAT program. Participants are not admitted to the program if they do not formulate treatment goals. Potential participants referred from one of the above noted sources are assigned to a therapist each Tuesday at a weekly meeting of the STAT program staff. The therapist will contact the individual and arrange a date for an initial interview. If a therapist is unable to reach an individual by phone, a letter with the date for an appointment is mailed along with the self-report questionnaire each client is expected to complete for the first interview with the therapist. The self-report materials include a series of questions to elicit a social history of the individual along with current stressors and self-identified problems. The assessment process involves roughly two appointments with the therapist and an additional appointment with the psychiatrist requiring roughly three weeks to complete. Participants will be given a letter of invitation outlining the research project as well as the SCL-90-R and DERS psychometric questionnaires. Individuals will be asked to complete the SCL-90-R and DERS at the beginning of their first appointment if they agree to participate in the research project.

Once an individual is accepted to the STAT Program, they are placed on the waiting list for a period of roughly four to six weeks. During that period, the therapist will meet with clients roughly two times to assist in formulating treatment goals and develop a therapeutic rapport. While a client is admitted to the program and participating in the groups, they are also seen by their assigned therapists on a weekly basis for an individual therapy session. Individual sessions with the therapist assist participants in understanding the psychoeducation group learning materials, assist with homework, and to process current stressors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • 18 years and older

排除标准

  • declined by the STAT Program

结局指标

主要结局

Self-harm, emotional distress, depression, anxiety

时间窗: Roughly 8 weeks.

The Symptom-Checklist-90-Revised is a psychometric measure used in research and clinical settings in measurement of outcomes related to treatment. It measures global severity of mental illness, positive symptom distress index, positive symptom total as well as nine dimensions of psychopathology on a 0 - 4 scale. Previous research studies on therapeutic interventions involving BPD participants have used the SCL-90-R to measure outcome. The SCL-90-R will be used to assess if the participants self-report a decrease in the severity of global indices of mental illness and nine specific psychopathology factors. Gratz and Roemer (2004) developed the Difficulties in Emotion Regulation Scale (DERS), a 36 item self-report survey to assess emotion dysregulation on six domains. DERS has good test-retest reliability and high internal consistency.

次要结局

未报告次要终点

研究者

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

Daryl Croft

Principal Investigator

University of Manitoba

研究点 (1)

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