A Randomized Controlled Trial of cognitive interventions in Patients with First Episode Psychosis to improve cognitive outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Equal to or more than for FOToM 0.98 SOToM 0.82 FPCI 0.91 SPI 0.89 SPI High Intensity 0.92 SPI Low Intensity 0.86 NSPI 0.93 NSPI High Intensity 0.94 NSPI Low Intensity 0.87 DF 10.04 DB 7.45 COWA Average New words 11.66 AVLT LTPR 93.45 Immediate Recall 13.33 Delayed Recall 13.41 Total Learning score 60 Interference 8.12 Hits 14.66 SPM IQ 122.12
研究概览
简要总结
Aim: To evaluate the efficacy of cognitive-based interventions in patients with first episode psychosis and to evaluate if it can improve the overall course and outcome of patients with FEP over the period of 6 months.
Objectives: To compare of the level of functioning, psychopathology, social cognitions, neurocognitions, quality of life, stigma, insight, and disability, in patients with FEP at the baseline. To develop cognitive rehabilitation intervention package. To evaluate improvement in cognitive deficits following cognitive interventions after a duration of 6 months vis-Ã -vis in the TAU arm.
*Methods:*This is a randomized control trial for the duration of 3 years. Those randomized to cognitive intervention arm will be assessed at baseline, at the end of the trial and after 6 months to evaluate the effect of cognitive interventions on the overall course and outcome. The sample is being obtained from the patient population attending outpatient or inpatient services of Department of Psychiatry of PGIMER, Chandigarh. The study sample will comprise 300 patients with FEP of which 150 will be randomized to each group (Intervention group and TAU group). Patients in both intervention and non-intervention group will be subjected to Treatment as usual which includes psycho-education, medications and periodic routine follow up. In the intervention group, additional cognitive remediation measures will be provided as per the cognitive deficits of the individual patient.
Outcome: The improvement of the level of functioning, psychopathology, social cognitions, neurocognitions, quality of life, stigma, insight, and disability in patients with FEP at the baseline. The development of cognitive rehabilitation intervention package. The evaluation of improvement in cognitive deficits following cognitive interventions after a duration of 6 months vis-Ã -vis in the TAU arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with schizophrenia as per DSM-5 criteria5, with duration of illness less than 5 years Currently in clinical remission as defined by Andreasen et al 20056.
排除标准
- •Patients who were not in clinical remission Those with comorbid organic brain syndrome or intellectual disability Those refuse to consent for the study.
结局指标
主要结局
Equal to or more than for FOToM 0.98 SOToM 0.82 FPCI 0.91 SPI 0.89 SPI High Intensity 0.92 SPI Low Intensity 0.86 NSPI 0.93 NSPI High Intensity 0.94 NSPI Low Intensity 0.87 DF 10.04 DB 7.45 COWA Average New words 11.66 AVLT LTPR 93.45 Immediate Recall 13.33 Delayed Recall 13.41 Total Learning score 60 Interference 8.12 Hits 14.66 SPM IQ 122.12
时间窗: 12 weeks post intervention
Equal to or Less than for CTMT Part A 29.54 Part B 69 SCWT score 42.16 Misses 0.33 False Alarms 0.41
时间窗: 12 weeks post intervention
次要结局
- Improvement in Level of functioning, disability and quality of life from baseline scores(12 weeks post intervention)
研究者
Dr Swapnajeet Sahoo
Post Graduate Institute of Medical Education & Research, Chandigarh