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临床试验/NCT02414763
NCT02414763已完成1 期

Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors

Western Kentucky University2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
69
试验地点
2
主要终点
Client Satisfaction Questionnaire

研究概览

简要总结

The current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will involve training of care providers affiliated with Vanderbilt University Medical Center to deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including readiness to change problematic behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming behavior, and reasons for living.

详细描述

One-hundred participants will be recruited from a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The PI, other Attending Psychiatrists, Psychiatry Resident Physicians, Clinical Psychology Trainees, Psychiatric Nurse Practitioners, Psychiatric Social Workers, and Psychiatric Nurse Case Managers will serve as study therapists. A member from the Vanderbilt University research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (1) a group receiving care as usual plus an experimental intervention targeting suicidal thoughts and behaviors or to (2) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the medical center, 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. All study participants will then complete telephone follow-up assessments at 1, 3, and 12 months. The intervention will consist of no more than 90 minutes of 1:1 interaction with a study clinician. The baseline assessment battery will take approximately 30 minutes, the post-intervention measures will take approximately 10 minutes, and the 1-, 3-, and 12-month assessment batteries will take approximately 30 minutes. Maximum length of time in the study is approximately 3.75 hours.

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)

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 of age and above
  • Inpatient on medical/surgical unit either currently or prior to transfer to inpatient psychiatric unit
  • Admitted following a suicide attempt
  • Sufficient English to benefit from psychotherapy in English
  • Consents to be a research participant

排除标准

  • Lack of sufficient English to participate in psychotherapy in English
  • Prisoner/inmate at time of admission
  • Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay in the medical center. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between discussions with research team members and the Adult Psychiatry Consultation Service Physician providing care to the patient, as well as the interventionist's own clinical assessment of the patient at the outset of the brief intervention.

研究组 & 干预措施

Care as Usual

No Intervention

Participants will receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management.

Teachable Moment Brief Intervention

Experimental

The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, functional analysis of the suicidal ideation and behaviors, and crisis response planning. Participants will also receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management.

干预措施: Teachable Moment Brief Intervention (Behavioral)

结局指标

主要结局

Client Satisfaction Questionnaire

时间窗: Immediately following Brief Intervention

The 8-item Client Satisfaction Questionnaire is a general measure of individual satisfaction with health and human services that takes 3-8 minutes to complete.

次要结局

  • Change in Stages of Change Questionnaire(Baseline, 1-, 3-, and 12-months interviews)
  • Change in Reasons for Living Inventory(Baseline, 1-, 3-, and 12-months interviews)
  • Change in Scale for Suicide Ideation(Baseline, 1-, 3-, and 12-months interviews)
  • Change in Suicide Attempt Self-Injury Count(Baseline, 1-, 3-, and 12-months interviews)
  • Change in Interpersonal Needs Questionnaire(Baseline, 1-, 3-, and 12-months interviews)
  • Change in Health Services and Medication Use(1-, 3-, and 12-months interviews)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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