Augmenting Early Phase Substance Use Treatment With Therapeutic Work Activity to Improve Clinical Outcomes: a New Indication for an Old Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- percent days abstinent
研究概览
简要总结
To date, there are no studies of the therapeutic effects of varied work-focused programs in Veterans undergoing outpatient substance use disorder (SUD) treatment. The investigators propose a randomized clinical trial to test the effects of work-focused programs on improving sobriety and other clinical outcomes in Veterans early in the course of recovery from SUD. Veterans will be randomized to either receive or not receive referral for work-focused therapeutic programs. Primary aim is to examine effects of work-focused programs on sobriety outcomes, namely sobriety and global functioning. Secondary aim is to examine effects of work-focused programs on psychiatric symptoms, self esteem/efficacy, and quality of life.
详细描述
The investigators propose a trial to test the effects of Incentive Therapy (IT) and Other Therapeutic and Supported Employment Services (Other TSES) on improving SUD outcomes in newly recovering Veterans in outpatient treatment. In line with eligibility criteria for different TSES programs, the investigators will employ a two branch study: One branch will be for Veterans who are not interested in pursuing competitive employment, and will be a two arm RCT with randomization (2:1) to referral for IT + treatment as usual (TAU; including usual SUD outpatient treatment) or TAU alone. The second branch will be for Veterans who express interest in competitive employment, and will be a two arm Randomized Controlled Trial (RCT) with randomization (2:1) to referral for TSES competitive employment services + TAU or TAU alone. Total Intent to Treat sample will be 140 (n=70 per branch). Primary outcomes will be percent days abstinent during 3 month active phase and clinical global impression scale scores at 6 months. Secondary outcome will be psychiatric symptoms, self esteem/efficacy and quality of life.
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)
盲法说明
Assessors will be blind to randomization status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be Veterans enrolled in VACHS substance use treatment, who at time of consenting into the study are within 30 days of detoxification or last substance use as per medical record.
- •Additional criteria will be as follows:
- •Meeting DSM-V criteria for any current Substance Use Disorder (SUD) (e.g., opioids, cocaine, marijuana, amphetamine, or alcohol)
- •Competent to give written informed consent and HIPAA authorization
排除标准
- •Involvement in a legal case that may lead to incarceration during study period
- •Developmental disability or medical illness that would prevent therapeutic work activity, as judged by PI or clinical staff providing this service
- •Plans to relocate outside geographic area that would make follow-up unlikely
- •And/or lack of willingness to provide contact information of someone who can help us contact the participant in the event that the investigators are unable to maintain contact directly
研究组 & 干预措施
treatment as usual plus referral to work focused program
usual substance use treatment plus referral to a competitive or non-competitive work-focused program
干预措施: referral to work focused program (Behavioral)
treatment as usual
usual substance use treatment
干预措施: treatment as usual (Other)
treatment as usual plus referral to work focused program
usual substance use treatment plus referral to a competitive or non-competitive work-focused program
干预措施: treatment as usual (Other)
结局指标
主要结局
percent days abstinent
时间窗: 3 months
percent days abstinent during 3-month active phase
Clinical Global Impression
时间窗: 6 months
Clinical Global Impression ratings conducted at 6 months from study entry.
次要结局
- change from baseline in New General Self-Efficacy Scale(6 months)
- change in WHOQOL BREF(6 months)
- change from baseline in BASIS-24(3 months)
- change from baseline in Rosenberg self-esteem scale(6 months)