Individual Placement and Support (IPS) and Cognitive Remediation Therapy (CRT) as an Adjunct to Treatment as Usual (TAU) in Patients With Early Schizophrenia Spectrum Disorder: Study Protocol for a Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Acceptability of the intervention, as determined by: number of sessions attended
研究概览
简要总结
This study aims to test the hypothesis that addition of Individual Placement and Support (IPS) and/or Cognitive Remediation Therapy (CRT) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.
详细描述
This is an assessor blind, randomised controlled trial, employing a factorial design. This trial aims to assess the feasibility of IPS, CRT or their combination as an add on to treatment as usual. Patients with early schizophrenia spectrum disorder will be recruited from major psychiatric units in Pakistan. Treatment as usual (TAU) will comprise of patient's current antipsychotic medication as prescribed by their responsible clinician. Patients will be randomised into IPS, CRT, their combination or TAU, according to the 2x2 factorial schedule in the table. A total of 30 participants will be recruited in each cell, giving a total of 120 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female patients aged between 18-35 years.
- •Diagnosis of schizophrenia confirmed by SCID meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
- •Stable on medication for the past four weeks.
- •In contact with mental health services
- •Within 5 years of diagnosis.
- •Able to demonstrate the capacity to provide informed consent to take part in this feasibility trial, as assessed by their own clinician.
排除标准
- •Active DSM-V substance abuse (except nicotine or caffeine) or dependence within the last three months
- •Relevant CNS or other medical disorders
- •Diagnosis of Learning Disability.
结局指标
主要结局
Acceptability of the intervention, as determined by: number of sessions attended
时间窗: 6 months post intervention
Therapy logs: therapy logs with number of sessions attended
Feasibility of undertaking a trial of the intervention, as determined by: Recruitment and attrition rates
时间窗: 6 month post intervention
Recruitment and attrition rates: This will be determined using recruitment and attrition rates into the trial
Client Satisfaction Questionnaire (CSQ)
时间窗: 6 month post intervention
Participants' satisfaction will be measured using CSQ-8. The scale consists of 8 items score range from 8 to 32, with higher values indicating higher satisfaction.
次要结局
未报告次要终点