跳至主要内容
临床试验/NCT03600532
NCT03600532终止不适用

Testing the Efficacy of the Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting: Effects on Psychosocial and Experimental Pain Outcomes

University of Tulsa4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018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
终止
发起方
入组人数
7
试验地点
4
主要终点
Changes in Beck Scale for Suicide Ideation

研究概览

简要总结

This study is looking at the helpfulness of a brief treatment targeting suicidality (Teachable Moment Brief Intervention [TMBI]) and experimental pain responses in an inpatient population as well as collecting comparison data from the community.

详细描述

The proposed study will use an innovative one-session psychotherapeutic intervention called the Teachable Moment Brief Intervention (TMBI) for suicide attempters admitted to a psychiatric inpatient unit. A total of 60 patients will be recruited from the inpatient psychiatry unit at Laureate Psychiatric Clinic and Hospital and 30 healthy community members for the study. Informed consent will be obtained for all participants and administration of the baseline assessment battery will be completed prior to randomization for patients. Patients will then be randomized to either (a) an experimental group receiving TMBI or (b) a group receiving treatment as usual (TAU). 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. All participants will complete a follow-up assessment immediately following TMBI, TAU, or a rest period. Further, patients receiving the experimental intervention will then be asked to complete a client satisfaction survey. The aim will be to assess whether TMBI affects psychological, experimental pain, and autonomic nervous system responses as compared to TAU and community controls.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • TMBI & TAU (data collection at Laureate Psychiatric Clinic and Hospital [LPCH])
  • admitted to LPCH subsequent to a suicide attempt

排除标准

  • acute psychosis,
  • inability to read English, or
  • taking narcotic or opioid pain medication
  • CCG (data collection in the Psychophysiology Laboratory for Affective Neuroscience [PLAN] on the University of Tulsa campus)
  • acute psychosis,
  • current suicide ideation,
  • history of self-harm,
  • inability to read English, or
  • taking narcotic or opioid pain medication

研究组 & 干预措施

Teachable Moment Brief Intervention

Experimental

The TMBI is informed by evidence based strategies to collaboratively identify 1) drivers of suicidal ideation, 2) functional aspects of the recent suicide attempt, 3) the patient's relationship with the concept of suicide, 4) what has been lost and gained as a result of the suicide attempt, 5) short term management suicide prevention management strategies, and 6) documentation of factors to address in a suicide-specific treatment plan.

干预措施: Teachable Moment Brief Intervention (TMBI) (Behavioral)

Treatment as Usual (TAU)

No Intervention

Usual care at Laureate Psychiatric Clinic and Hospital Adult Stabilization Unit who have attempted suicide involves psychiatric evaluation/treatment and ongoing medical stabilization. Patients will engage in usual care or a rest period before completing the post-assessment.

Community Control Group (CCG)

No Intervention

Patients will engage in a rest period before completing the post-assessment.

结局指标

主要结局

Changes in Beck Scale for Suicide Ideation

时间窗: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

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

  • Changes in Stages of Change Questionnaire(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Reasons for Living Inventory(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Adult State Hope Scale(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Change in Positive and Negative Affect Schedule(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Ischemic Pain Outcomes(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Mechanical Pressure Pain Outcomes(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Temporal Summation of Pain(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Skin Conductance Level(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Blood Pressure(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
  • Changes in Cardiovascular Measurements(Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))

研究者

发起方
University of Tulsa
申办方类型
Other
责任方
Sponsor

研究点 (4)

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