A Pilot Trial of Health Coaching to Improve Functioning and Reduce Suicide Risk Among Reintegrating Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Well-being Inventory - Functional Status
研究概览
简要总结
Health coaches help people focus on goals, identify strengths and values, and work towards building the life they wish to live. Health coaching may be especially helpful for people navigating a life transition, such as Veterans who recently separated from military service (i.e., reintegrating Veterans). In this pilot trial the investigators will 1) examine the feasibility of study procedures and acceptability of health coaching among reintegrating Veterans, 2) evaluate measures for suitability in a future trial that will examine efficacy of the intervention, 3) determine barriers and facilitators to implementing the intervention among reintegrating Veterans.
详细描述
This pilot study is designed to provide data to inform the design and procedures of a future efficacy trial of health coaching among reintegrating Veterans. An enrollment rate 30% and an assessment completion rate 65% at 9 months will be considered feasible enrollment and assessment completion rates for a future efficacy trial. An intervention completion rate 70% and mean score 27 on the Client Satisfaction Questionnaire-8 will indicate acceptability. Evaluation of measures will entail quantifying the mean levels in this population, characterizing typical variation in the outcomes, descriptive analyses of within-person change across time, and adjusted estimates of treatment effect sizes with 95% confidence intervals to calibrate the sample size needs of a fully powered trial. Qualitative interviews with participants will provide information on barriers and facilitators to implementation as well as perceived benefits and potential harms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •United States military Veterans recently separated from service
排除标准
- •Currently living in an institution (e.g., nursing home, prison)
- •Cognitive impairment as indicated by a score equal to or greater than 10 on the Short Blessed Test
- •Currently experiencing psychosis as indicated by endorsing thought interference or hallucinations on the Psychosis Screening Questionnaire
- •At acute risk for suicide as indicated by the P4 screener
- •Unable to read or understand English
研究组 & 干预措施
Health Coaching
Receipt of up to 12 sessions of health coaching, plus printed materials providing information on VA benefits
干预措施: Health Coaching (Behavioral)
Health Coaching
Receipt of up to 12 sessions of health coaching, plus printed materials providing information on VA benefits
干预措施: VA Benefits Information (Behavioral)
VA Benefits Information
Receipt of printed materials providing information on VA benefits
干预措施: VA Benefits Information (Behavioral)
结局指标
主要结局
Well-being Inventory - Functional Status
时间窗: Month 9
The Functional Status composite measure from the Well-being Inventory scores range from 1 to 5, with higher scores indicating a higher level of functioning.
Depressive Symptom Index - Suicidality subscale
时间窗: Month 9
The Suicidality subscale of the Depressive Symptom Index scores range from 0 to 12, with higher scores indicating higher suicidal ideation severity.
Columbia Suicide Severity Rating Scale
时间窗: Month 9
The Columbia Suicide Severity Rating Scale - Screen scores range from 0 to 7, with higher scores indicating higher suicidal ideation severity.
Military to Civilian Questionnaire
时间窗: Month 9
The Military to Civilian Questionnaire scores range from 0 to 4, with higher scores indicating a higher degree of reintegrating difficulty.
Columbia Suicide Severity Rating Scale
时间窗: Month 4
Reported as count of participants with no suicidal ideation
次要结局
- Number of VA healthcare visits (primary care, mental health, or other specialty care visits)(Month 9)