Cognitive Remediation Therapy for Patients With Serious Mental Illness Who Failed to Benefit From Supported Employment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Employment Outcomes
研究概览
简要总结
The purpose of this study is to help people with serious mental illness get and keep the job they want by improving their thinking skills, using cognitive remediation therapy. For people with serious mental illness, the Individual Placement and Support (IPS) Program is an effective approach to help people become employed. Despite its general success, still only 55% of clients find employment. Most of that success occurs in the first three months; after six months, the chances of finding competitive work are quite low. Among those who fail to find employment with IPS, cognitive dysfunction is often a significant problem. The proposed study will target IPS clients who have not found work after 3 months of employment-support services: our hypothesis is that, after three months with no success, the addition of cognitive remediation to IPS will improve employment rates (compared to those who continue to receive IPS alone).
The proposed randomized controlled trial will use a single-blind study design, focused on IPS clients who are slow to (or may never) find employment success. Specifically, the proposed study will have two treatment arms: a) cognitive remediation added to continued IPS services, and b) continued IPS services alone. The study will collaborate with IPS workers at 11 Mental Health and Substance Use (MHSU) clinics to identify clients who are non-responders in the first 3 months, and seek their consent to participate in the study. They will be randomized to either TAU (continuation with IPS and other standard treatments), or TAU plus cognitive remediation. The CRT will consist of computerized cognitive exercise practice, strategy coaching, and teaching coping/compensatory strategies for 12 weeks. Clients will be assessed at 3-time points: prior to the start of cognitive remediation ("baseline"), end-point (3-month), and 6 months after the endpoint evaluation. Primary outcome measures will include success at gaining a competitive job, total hours of competitive employment, and neuropsychological measures of cognition.
详细描述
Background Information:
The Individual Placement and Support (IPS) program is an evidence-based vocational rehabilitation services that assist individuals with mental illness or significant mental health concerns gain and maintain competitive employment in the community. Unemployment rates among people with mental illness are high, even though most people with serious mental illness want to work.
Fraser Health provides IPS services to approximately 350 MHSU clients per year in six communities. The IPS strategy helps about 55% of clients find competitive jobs, but almost half (45%) fail to find work. Among those who fail to find employment, cognitive dysfunction is often a significant problem.
Cognitive remediation therapy (CRT) is an evidence-based, psychological treatment for the neurocognitive deficits seen in patients with severe mental illness. CRT targets cognitive functioning with the goal of improving role functioning in daily life. When compared with employment intervention alone, programs that incorporate CRT have shown a variety of vocational benefits, (e.g., more likely to work, held more jobs, worked more weeks, and earned more in wages) that are maintained even at a 3-year follow-up. CRT targeted to clients who have not been successful with IPS is efficient: non-responders improved employment outcome with a number needed-to-treat (NNT) of 4 over a two-year period.
Cognitive remediation (CRT) improves thinking skills and work functioning. CRT provides specific training modules and exercises that target thinking skills known to be impaired in severe mental illness. For example, working memory and cognitive flexibility are trained through real-world exercises that teach clients to organize and manage time, focus their attention, consider errors and their consequences, control answers and plan ahead. These skills are important to be successful in obtaining and maintaining employment.
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
This randomized controlled trial will use a single-blind study design with two treatment arms. The research team that assesses participants at baseline and follow-up will have no knowledge of their assigned treatment arm. The participants, however, will know which treatment arm they have been assigned.
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 19-60 years old
- •Enrolled in the IPS program for at least 3 months
- •Clinically stable (no changes to psychiatric medication and psychiatric hospitalization in the 30 days prior to intake)
排除标准
- •History of traumatic brain injury
- •Neurological disorder
- •Developmental disability
- •Difficulty understanding written and spoken English
结局指标
主要结局
Employment Outcomes
时间窗: 90 days
The number of hours client worked in the past 90 days.
次要结局
- Cognitive Functioning(90 minutes)
- Psychiatric Symptoms(2 weeks)