跳至主要内容
临床试验/NCT03533075
NCT03533075已完成不适用

A Pilot Effectiveness Trial of the Teachable Moment Brief Intervention (TMBI) for Veterans Hospitalized Following a Suicide Attempt

Louisville VA Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Suicide Attempt Self-Injury Count

研究概览

简要总结

The overall objective is to determine the acceptability and feasibility of the Teachable Moment Brief Intervention (TMBI) + follow-up consultation for Veterans treated on an inpatient psychiatry unit following a suicide attempt. The study will also determine whether there is a signal of effectiveness supporting the TMBI in improving the recovery trajectory of Veterans following discharge to the community.

详细描述

A total of 50 patients will be recruited from the inpatient psychiatry unit for the study. A member from the research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (a) an experimental group receiving TMBI + follow-up consultation or (b) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the hospital, most likely on the same day as the baseline assessment battery. Patients receiving the experimental intervention will then be asked to complete a brief post-intervention client satisfaction survey administered by a research team member. All study participants will then complete telephone follow-up assessments at 1 and 3-month time points administered by members of the research team and supervised by the PI. Additionally, patient electronic medical records will be abstracted to document the following health services and clinical characteristics in the 12 months following enrollment in the study: death for any reason, inpatient hospitalization (both medical/surgical and psychiatric), emergency department visits, suicide attempt and other forms of self-directed violence, all outpatient appointments with VA service providers, and diagnosis. The PI will rate the TMBI sessions for the interventionists. When the PI delivers the intervention, a trained member of the research team will review the PI's sessions and rate for adherence. The intervention will consist of no more than 90 minutes (expected mean is 45 minutes for the intervention based upon previous studies of the TMBI) of 1:1 interaction with a study clinician. The baseline assessment battery will take approximately 30 minutes, the post-intervention measure will take approximately 5 minutes, and the 1 and 3-month assessment batteries will take approximately 30 minutes. The PI and potentially 2 to 3 members of the Suicide Prevention Program will provide the intervention to ~25 randomized patients.

Notes will be kept on patients who decided to drop out of the intervention and/or the study. We will examine the mean and standard deviation for the total score and individual items on the Client Satisfaction Questionnaire. Notes will be kept documenting all contacts for recruitment and the number of eligible patients per month. Reasons for inclusion and exclusion of potential participants will be documented as well as reasons participants give for choosing not to participate. Number of patients enrolled and randomized each month will be documented. Notes will be kept of rates of on-time outcome assessments and days late and any assessments missed or participants lost to contact.

Descriptive statistics for demographic and clinical variables will be tabulated. All scales will be scored and subscales described. This process will include examining the data for missing values, appropriate ranges, and outliers. Although the randomization design should ensure balance between the two groups, it is essential to control for any known confounders in the design and analysis to prevent a biased assessment of the brief intervention effect. Any baseline demographic or clinical variables found to be statistically significant in the analysis will be included as covariates in all analytic models. We will use an intent-to-treat sample to complete our analyses. We will utilize mixed-effects regression models to obtain between-groups effect sizes for the impact of the TMBI + consultation on elevating motivation, hope, reasons for living and social connection.

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
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will remain blinded to the treatment condition for all participants.

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

  • Veteran service member
  • Recently admitted to an inpatient psychiatry unit at the VAMC site following a suicide attempt
  • 18 or more years of age
  • Consents to participate in baseline and follow-up interviews and gives permission to review records for previous year and subsequent year.
  • Consents to randomization and participation in TMBI + follow-up or Care as Usual
  • Consents to audio recording in order for PI to conduct adherence rating

排除标准

  • Significant psychosis, cognitive, or other problems that prevent participant from understanding the study procedures or renders them unable to provide informed consent (suggesting that psychosocial therapeutic care is contra-indicated)
  • Judicially-ordered to treatment (e.g., subsequent to domestic violence) such that participation in study procedures could not be considered voluntary and participant is not free to drop out without significant negative consequences.

结局指标

主要结局

Suicide Attempt Self-Injury Count

时间窗: 3 months

two-page instrument determining for the first, most recent, and most severe suicide attempt or non-suicidal self-injury (SASI) the date, method of SASI attempt used in index and previous attempts according to the definitions of Linehan et al. (e.g., using definitions of self-inflicted injuries which include situations of actual tissue damage and situations where tissue damage would have occurred except for outside intervention or sheer luck \[e.g., firearm jammed\]), intent to die (i.e., intent to die, ambivalent, no intent to die), highest level of medical treatment received, and lethality

Changes in Reasons for Living Inventory

时间窗: 3 months

48-item measure that rates the importance of different reasons why people choose not to kill themselves. Total score will be reported, which ranges from 48 (low reasons for living) to 288 (High reasons for living).

Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness.

时间窗: 3 months

15-item measure of the extent to which individuals feel connected to others (i.e., belongingness) and like a burden on people in their lives (i.e., perceived burdensomeness). Subscale total scores for thwarted belongingness and perceived burdensomeness will be reported. For thwarted belongingness, scores range from 9 (low) to 63 (high). For perceived burdensomeness, scores range from 6 (low) to 42 (high).

Changes in Stages of Change Questionnaire, which measures motivation

时间窗: 3 months

18-item measure that measures motivation to engage in treatment/work on problems. Total score will be summed from all items, with range from 18 (low motivation) to 90 (high motivation). Four subscales will also be reported as follows: Precontemplation ranges from 5 (low) to 25 (high) with higher scores indicating higher motivation. Contemplation ranges from 4 (low) to 20 (high) with higher scores indicating higher motivation. Action ranges from 5 (low) to 25 (high) with higher scores indicating higher motivation. Maintenance ranges from 4 (low) to 20 (high) with higher scores indicating higher motivation.

Changes in State Hope Scale

时间窗: 3 months

6-item measure of ongoing self-directed thinking. Total score will be reported, which ranges from 6 (low hope) to 48 (high hope).

Changes in Beck Scale for Suicide Ideation

时间窗: 3 months

19-item assessment used to evaluate the current intensity of the patient's specific attitudes toward, behavior, and plans to commit suicide. Total score will be reported which ranges from 0 (no suicidal ideation) to 38 (high suicidal ideation)

次要结局

  • Outpatient Health Services Engagement(12 months)
  • Acute Care Health Services(12 months)
  • Self-Directed Violence(12 months)

研究者

发起方
Louisville VA Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Stephen O'Connor, Ph.D.

Research Facilitator

Louisville VA Medical Center

研究点 (2)

Loading locations...

相似试验

Teachable Moment Brief Intervention for Veterans... | 临床试验