Online Training Program on Social Cognition for Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes
研究概览
简要总结
Randomized controlled trial. Sixty-five participants (83% with schizophrenia or bipolar disorder) were recruited from community mental health teams. Fifty-seven met criteria and agreed to participate in the study. The conditions of cognitive rehabilitation were assigned randomly with support employment CR + IPS (n = 28) and IPS alone (n = 29). Cogpack program was used. Two groups were followed at 8 and 12 months after the baseline.
详细描述
This work was developed in the island of Tenerife (Spain) within a public service specialised in labour integration of people with disabilities in which an IPS team was set up in 2005. The study was carried out in collaboration with the units of community mental health of the island. These units carry out the control of people with serious mental illnesses including pharmacological treatment and psychosocial programming. All research procedures were approved by the Medicine Committee of Canary Health Services.
The follow-up period for the data collection was set between 2013 and 2014. Employment specialists belong to a public institution specialized in work disability.Sixty-five participants but only 57 signed written informed consent and completed the baseline. Two groups were assigned randomly:one with support employment and cognitive rehabilitation the second group with IPS alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Experimental: ET and IPS Control: IPS
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants had to:
- •comply with the state definitions of severe mental illness (SMI), which includes an ICD-10 (World Health Organization, 1992) diagnosis of F20- 29 (schizophrenia, schizotypal, delusional and other non-mood psychotic disorders) and F31-F32.3 (major mood affective disorders)
- •have previous difficulties to maintain a job
- •currently want a competitive job and
- •accept the job search starts
排除标准
- •People with no Severe mental illness and not want to participate
结局指标
主要结局
Screening for Cognitive Impairment in Psychiatry (SCIP-S) total score changes
时间窗: At baseline and after 1 year treatment
Minimum 1 and maximum 99, very low range 1-2.5 and low range 2.5-15. The deterioration depends on the scale.
Happé Strange Stories Test total score changes
时间窗: At baseline and after 1 year treatment
Total control minimum 0 and maximum 16. Total theory of mind minimum 0 and maximum 16. Cut-off point 14, below the deficit.
Movie for the Assessment of Social Cognition total score changes
时间窗: At baseline and after 1 year treatment
Minimum 0 and maximum 42.
Ambiguous Intentions and Hostility Questionnaire total score changes
时间窗: At baseline and after 1 year treatment
Hostility, anger, guilt and aggression minimum 1 and maximum 5. Intentionality minimum 1 and maximum 6. Calculate the mean.
Positive and Negative Symptom Scale (PANSS) total score changes
时间窗: At baseline and after 1 year treatment
Positive and negative subscales minimum 7 and maximum 49. General psychopathology subscale minimum 16 and maximum 112. Composite subscale minimum -42 and maximum +42. Categorize subtype positive \>0 and negative \<0.
Ekman 60 Faces Test total score changes
时间窗: At baseline and after 1 year treatment
Minimum 0 and maximum 60. Between 20-40 years average 51.43, cut-off point 45, below deficit. Between 40-60 years, average 51.20, cut-off point 43, below deficit.
Faux Pas Recognition Test total score changes
时间窗: At baseline and after 1 year treatment
FP stories and C questions, C stories and FP questions and C stories and C questions minimum 0 and maximum 20. FP stories and FP questions minimum 0 and maximum 60. Cut-off point without errors 54 and with errors 48, lower deficit scores.
Hinting Task total score changes
时间窗: At baseline and after 1 year treatment
Total 1 minimum 0 and maximum 20. Total 2 minimum 0 and maximum 10. Cut-off point 18, less deficit.
次要结局
- Employment(Up to 12 months in 2021)
研究者
Francisco Pulido
Professor of Psychiatry
University of La Laguna