跳至主要内容
临床试验/NCT02751983
NCT02751983已完成不适用

ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年11月15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
70
试验地点
2
主要终点
Reasons for Termination (Client and Therapist Versions)

研究概览

简要总结

An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public health policy both call for treatment targeting high-risk populations, such as Veterans hospitalized due to suicidal intent and/or attempts. Psychiatric hospitalization is a critical opportunity to provide treatment to reduce the risk of suicide and lay the groundwork for functional recovery. Yet, there are no interventions specifically for suicide prevention that meet Veterans Health Affairs' quality recommendations requiring the provision of evidence-based, recovery-oriented psychotherapy, which are also feasible to use during a typical inpatient stay. The proposed study seeks to take a first step toward filling this gap. In consultation with experts in the field, the authors have developed a protocol applying a recovery-oriented, evidence-based treatment approach to Veteran inpatient care. The proposed pilot study will provide critical information to inform final revisions of the treatment manual and research design for a future study evaluating the efficacy of the intervention.

详细描述

Psychiatric hospitalization presents a critical opportunity for delivering targeted treatment to reduce suicide risk and promote functional recovery. Yet, there are no suicide-specific empirically-supported interventions that can be feasibly delivered during a typical Veterans Health Affairs (VHA) inpatient stay. Although VHA now requires the provision of evidence-based, recovery-oriented inpatient psychotherapy, extant empirically-supported interventions for patients at high risk of suicide were developed for use in outpatient settings and are too time- and resource-intensive to implement as intended in inpatient psychiatric settings, where shorter lengths of stay are expected. Furthermore, these interventions focus nearly entirely on preventing suicidal behavior without also targeting functional recovery. Similarly, inpatient psychiatric treatment has traditionally focused on medical management of acute illness, not on improving patient functioning. Preventing suicide during a crisis is only a short-term solution if the investigators fail to assist patients in understanding how they can rebuild a life they deem worth living. Given that approximately 50% of inpatients do not engage in recommended outpatient mental health care and are at the highest risk of death by suicide, it is vital that inpatient care promote functional recovery. The ideal brief intervention for Veterans at risk for suicide needs to reduce risk of suicidal behavior while simultaneously fostering recovery.

Acceptance and Commitment Therapy (ACT) is a recovery-oriented, psychosocial treatment approach ideally suited for utilization among Veterans hospitalized for suicide risk. ACT teaches psychological skills to handle painful thoughts, emotions, and sensations, but rather than focusing on symptom reduction, ACT directly targets functional recovery by assisting patients in identifying and engaging in value-consistent behaviors despite the potential for distress. There are no brief, ACT-based, transdiagnostic treatment protocols designed to address suicide risk. In order to fill this gap, the investigators consulted with leading experts in ACT to develop and manualize "ACT for Life", a brief, transdiagnostic, recovery-oriented intervention for Veterans hospitalized due to suicide risk. The ACT for Life manual details the application of ACT to recovery from suicidal crises and consists of three modules, [designed to be utilized in three to four 60-minute individual sessions.] This two arm, randomized, controlled pilot study will provide critical information to inform final revisions to the treatment manual and research design for a future efficacy study of ACT for Life. Veterans who enroll in the study will be randomized to: (a) treatment as usual or (b) treatment as usual plus ACT. The specific aims of this study are to: (1) Determine the acceptability of ACT for Life. (2) Determine the feasibility of the study design and research procedures. (3) Characterize participants' psychosocial functioning and self-directed violence using candidate outcome measures for a future efficacy trial. All participants will complete a baseline assessment, and follow-up assessments one and three months after hospital discharge. Participants in the ACT group will also complete a post-treatment assessment on acceptability of the intervention.

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible for Veterans Health Administration care
  • Age 18-89
  • Currently hospitalized due to suicide risk
  • Willing to be randomized and participate in the two conditions

排除标准

  • Inability to provide informed consent
  • Inability to complete study measures, e.g.:
  • due to significant acute intoxication/withdrawal symptoms
  • psychosis
  • aggression
  • catatonia
  • cognitive impairment
  • membership in vulnerable population, e.g.:
  • prisoners

结局指标

主要结局

Reasons for Termination (Client and Therapist Versions)

时间窗: Post-treatment (0-7 days after treatment termination)

Self-report scale which assesses the impact of 19 common reasons why patients terminate therapy. Will be used to assess treatment acceptability. These participants reported reasons for termination of ACT, but this did not produce quantitative data.

Client Satisfaction Questionnaire - 8

时间窗: Post-treatment (0-7 days after treatment completion)

Self-report measure that will be used to assess participants' satisfaction with ACT for Life. Scale scores range from 8 to 32 with higher scores indicating greater satisfaction. For the purposes of the current study scores greater than or equal to 24 were considered acceptable. The number of participants scoring ≥ 24 is reported below.

Narrative Evaluation of Intervention Interview

时间窗: Post-treatment (0-7 days after treatment completion)

Semi-structured interview assessing each participants' perspective of the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. Will be used to assess acceptability and inform revisions to the treatment manual. Qualitative Thematic Analysis was conducted. There are no objective data to report from this interview. Please contact the PI for reference to a manuscript with the qualitative results.

次要结局

  • Outcome Questionnaire 45.2 (OQ-45)(Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up)
  • Valued Living Questionnaire (Used to Assess Change)(Pre-treatment, and one- and three-month follow-ups)
  • Inventory of Psychosocial Functioning (Used to Assess Change)(Pre-treatment, and one- and three-month follow-ups)
  • PROMIS Global Short Form v1.1 (Used to Assess Change)(Pre-treatment, and one- and three-month follow-ups)
  • PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)(Pre-treatment, and one- and three-month follow-ups)
  • Columbia Suicide-Severity Rating Scale (Used to Assess Change)(Pre-treatment, and one- and three-month follow-ups)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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