跳至主要内容
临床试验/NCT07097376
NCT07097376招募中不适用

Evaluating the Efficacy of a Vocational Counseling Intervention to Improve Occupational Functioning and Employment Quality Among Veterans With Mental Health and Substance Use Disorders

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
254
试验地点
6
主要终点
Number of Participants with Competitive Employment

研究概览

简要总结

Veterans living with mental health and substance use conditions are at risk of unemployment, which leads to significant health-related consequences. Though the Veterans Health Administration offers numerous vocational rehabilitation programs to address unemployment, they are not uniformly effective for everyone who participates. This project will test a new model for addressing Veteran unemployment. This new model adds career development services (a vocational counseling program called Purposeful Pathways) to a standard model of vocational rehabilitation (a program called Transitional Work [TW]). The investigators will test if adding Purposeful Pathways to TW leads to more Veterans working in quality jobs as well as better quality of life, reduced mental health symptoms, and reduced substance use. This project fills a critical need in advancing research and practice aimed at reducing Veteran unemployment; thereby preventing consequences to Veteran's economic, social, and health related functioning and well-being.

The investigators will conduct a phase II, multi-site, RCT comparing Purposeful Pathways + TW (n=127) to TW alone (n=127) among Veterans participating in TW at VA Bedford, VA Hines, and VA North Texas. Aim 1: Evaluate the efficacy of Purposeful Pathways for improving occupational functioning (primary outcome). Hypothesis: Purposeful Pathways + TW, compared to TW only, will improve occupational functioning. Aim 2: Evaluate the efficacy of Purposeful Pathways for improving quality of life, and reducing mental health symptoms and substance use (secondary outcomes). Hypothesis: Purposeful Pathways + TW, compared to TW only, will improve quality of life, and reduce mental health symptoms and substance use. Aim 3 (Exploratory): Explore whether occupational functioning (competitive employment attainment) in the Purposeful Pathways + TW group is mediated by vocational identity, work hope, self-regulation, and/or employment motivation, key factors central to the Purposeful Pathways intervention.

详细描述

The investigators will conduct a multi-site efficacy RCT comparing Purposeful Pathways + transitional work (TW) (n=127) to TW alone (n=127) with sites at VA Bedford (Bedford, MA), VA Hines (Chicago, IL), and VA North Texas (Dallas, TX). The proposed project will allow us to evaluate the efficacy of Purposeful Pathways as an augmentation to TW for improving the primary outcome of occupational functioning, as well as downstream improvements in secondary outcomes of quality of life, mental health, and substance use. The investigators will also explore whether occupational functioning outcomes in the Purposeful Pathways + TW group are mediated by the factors proposed by the underlying theoretical model for Purposeful Pathways.

Aim 1: Evaluate the efficacy of Purposeful Pathways for improving occupational functioning (primary outcomes) Hypothesis 1a-e: Purposeful Pathways + TW, compared to TW only, will improve occupational functioning at a 12-month follow-up as evidenced by (1a) rates of competitive employment, (1b) hours worked, (1c) income earned, (1d) career adaptabilities (Career Adapt-Abilities Scale), and (1e) meaningful employment (Work as Meaning Inventory-Positive Meaning Subscale).

Aim 2: Evaluate the efficacy of Purposeful Pathways for improving quality of life, and reducing mental health symptoms and substance use (secondary outcomes) Hypothesis 2a-c: Purposeful Pathways + TW, compared to TW only, will improve (2a) quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form), and reduce (2b) mental health symptoms (Patient Health Questionnaire) and (2c) substance use (Tobacco, Alcohol, Prescription medications, and other Substance tool) at a 12-month follow-up

Aim 3 (Exploratory): Explore whether occupational functioning (competitive employment attainment) in the Purposeful Pathways + TW group is mediated by vocational identity, work hope, self-regulation, and/or employment motivation, key factors central to the Purposeful Pathways intervention.

The study intervention is a behavioral intervention. Purposeful Pathways is a manualized, vocational counseling intervention based on a Veteran-centered, recovery-oriented approach. The overarching target of the intervention is to increase motivation to pursue meaningful employment goals by enhancing vocational identity/positive vocational self-appraisals, increasing work hope (goals, pathways, and self-efficacy), and promoting employment-related self-regulation skills. The table below provides an overview of the specific treatment elements associated with each of the four core components: 1) career/identity exploration, 2) goal setting/planning, 3) job-search skill building, and 4) self-regulation skill building. The Purposeful Pathways intervention will be provided over 12 weeks by a master's level clinician affiliated with their respective (Bedford, Hines, of North Texas) vocational rehabilitation program. Sessions will be provided in person or through the VHA telehealth services platform (VVC).

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

  • enrolled in VHA TW at one of the three VA recruitment sites
  • be unemployed
  • report interest/intention to return to paid work within the upcoming three years
  • presence of a psychiatric disorder as indicated by documented ICD-10 diagnosis (mental health disorder and/or substance use disorder) addressed in an encounter at VHA within the 24 months preceding study enrollment
  • willing to participate in weekly vocational counseling sessions

排除标准

  • report a plan to remain unemployed during the upcoming 12 months
  • report plans to retire within the next 12 months
  • be currently retired
  • be a full-time student
  • enrolled in Supported Employment
  • experiencing significantly elevated mental health symptoms as indicated by a score greater than 26 on the Symptom Checklist-6 (SCL-648)
  • have a guardian or conservator

研究组 & 干预措施

Purposeful Pathways

Experimental

Participants in this arm will receive treatment as usual, which is the transitional work intervention, as well as the Purposeful Pathways intervention

干预措施: Purposeful Pathways (Behavioral)

Purposeful Pathways

Experimental

Participants in this arm will receive treatment as usual, which is the transitional work intervention, as well as the Purposeful Pathways intervention

干预措施: Transitional Work (Other)

Treatment as usual

Active Comparator

Participants in this arm will receive treatment as usual, which is the transitional work intervention.

干预措施: Transitional Work (Other)

结局指标

主要结局

Number of Participants with Competitive Employment

时间窗: through study completion, an average of 15 months

Number of participants who were competitively employed at any point over the previous month. We define competitive employment as a non-sheltered job that earns salary, wages, or commission, excluding military drill and transient cash-based jobs, such as yard work, babysitting, and manual day labor.

Income earned

时间窗: through study completion, an average of 15 months

Total wages from competitive employment earned over the past month

Number of days worked

时间窗: through study completion, an average of 15 months

The number of days worked in competitive employment over the past month

Total hours worked

时间窗: through study completion, an average of 15 months

The number of hours worked in competitive employment during previous month

Career Adapt-Ability Scale

时间窗: through study completion, an average of 15 months

One's functional abilities/strengths to successfully manage career-related tasks. Possible scores range from 24 - 120, with greater scores indicating greater career adaptability functioning.

Positive Meaning Scale of the Work as Meaning Inventory

时间窗: through study completion, an average of 15 months

Degree to which someone perceives their work as meaningful. Scores range from 4 - 28, with higher scores representing greater levels of meaningful work.

次要结局

  • Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(through study completion, an average of 15 months)
  • Patient Health Questionnaire-9(through study completion, an average of 15 months)
  • Alcohol misuse(through study completion, an average of 15 months)
  • Heroin misuse(through study completion, an average of 15 months)
  • Marijuana misuse(through study completion, an average of 15 months)
  • Cocaine, crack, or methamphetamine misuse(through study completion, an average of 15 months)
  • Prescription opiate misuse(through study completion, an average of 15 months)
  • Medication for anxiety or sleep misuse(through study completion, an average of 15 months)
  • Medication for ADHD misuse(through study completion, an average of 15 months)
  • Other illegal or recreational drug use(through study completion, an average of 15 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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