A Randomized Controlled Trial to Evaluate the Efficacy of Metacognitive Training for Schizophrenia Applied by Mental Health Nurses: Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Psychotic Symptom Rating Scales (PSYRATS) - moment 2
研究概览
简要总结
Metacognitive training (MCT) for schizophrenia has been used in several countries, but its efficacy remains unclear. MCT is a program group that consists of changing the cognitive infrastructure of delusions.
This study aims to evaluate the efficacy of the Portuguese version of the metacognitive training programme and its effects on psychotic symptoms, insight to the disorder and functionality
详细描述
A randomized controlled trial that will be realized in six psychiatric institutions of Portugal. Pilot study will be carried out initially. The sample will be constituted by individuals diagnosed with schizophrenia (experimental group (n=30) and control group (n=30). The evaluation instruments will be utilized are PSYRATS, BCIS, PSP and WHODAS 2.0 applied to both groups in three different moments. In experimental group the eight MCT modules will be applied over four weeks.
The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the Metacognitive Training for Schizophrenia.
The hypothesis to be validated in this trial are:
- the schizophrenic patients who integrate the experimental group and participate in the MCT program will reduce the severity of psychotic symptoms and will present a better insight to disease and a better functioning on the final of the program than the control group;
- in participants that participating in the MCT program, the psychotic symptoms decrease at the end of the program and in the follow up (three months later) and the awareness for the disease and functioning improves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Eligible participants will be recruited by the investigators in collaboration with the multidisciplinary team of each institution. A baseline assessment will be carried out and the instruments will be applied after informed consent by participants. Participants will be randomly allocated to either Metacognitive Training (MCT) (experimental group). The control group will not participate in the MCT program. In both groups will be maintained the TAU. The variables for whom the participants are stratified are educational level, duration of mental disorder and type of treatment. All participants will be re-assessed at the end of the program and three months later. The program will be applied during four weeks (two session per week).
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
- •age between 18 and 65 years;
- •diagnosis of schizophrenia evaluated by Psychiatrist Assistant;
- •that didn't have any changes in neuroleptics medication four months before program.
排除标准
- •substance dependence;
- •very severe psychotic symptoms that impedes understanding the objectives of the sessions;
- •had changes in neuroleptics medication four months before program.
结局指标
主要结局
Psychotic Symptom Rating Scales (PSYRATS) - moment 2
时间窗: PSYRATS will be applied up to 1 week after eight session, to both groups.
This instrument is a structured interview that assesses the detailed measurement of delusions and hallucinations. The PSYRATS have 17 items and two subscales: one subscale assesses delusions (6 items) and the other subscale assess hallucinations (11 items). Each item has a classification of five points (0-4). The total score is the sum of all points. It is was developed by Haddock, McCarron, Tarrier and Faragher in 1999 (validated for the Portuguese population by Telles-Correia et al in 2017).
Beck Cognitive Insight Scale (BCIS) - moment 3
时间窗: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
This scale has 15 items and it is a self-response questionnaire that was developed by Beck, Baruch, Balter, Steer, \& Warman in 2004 and evaluated the consciousness of the illness. The BCIS is comprised of two subscales: self-reflectiveness and self-certainty. The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty. Poorer cognitive insight is indexed by lower scores on the self-reflectiveness subscale, higher self-certainty scores, and lower BCIS composite index scores. Step 1. Score every item on the BCIS from "0" to "3" according to the following rule: * "Do Not Agree at All" = 0 * "Agree Slightly" = 1 * "Agree a Lot" = 2 * "Agree Completely" = 3 (in process of validation to Portuguese population by investigators of this study)
Psychotic Symptom Rating Scales (PSYRATS) - moment 1
时间窗: PSYRATS will be applied a week before the first session of Metacognitive Training.
This instrument is a structured interview that assesses the detailed measurement of delusions and hallucinations. The PSYRATS have 17 items and two subscales: one subscale assesses delusions (6 items) and the other subscale assess hallucinations (11 items). Each item has a classification of five points (0-4). The total score is the sum of all points. It is was developed by Haddock, McCarron, Tarrier and Faragher in 1999 (validated for the Portuguese population by Telles-Correia et al in 2017).
Psychotic Symptom Rating Scales (PSYRATS) - moment 3
时间窗: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program, in both groups.
This instrument is a structured interview that assesses the detailed measurement of delusions and hallucinations. The PSYRATS have 17 items and two subscales: one subscale assesses delusions (6 items) and the other subscale assess hallucinations (11 items). Each item has a classification of five points (0-4). The total score is the sum of all points. It is was developed by Haddock, McCarron, Tarrier and Faragher in 1999 (validated for the Portuguese population by Telles-Correia et al in 2017).
Beck Cognitive Insight Scale (BCIS) - moment 1
时间窗: BCIS will be applied a week before the first session of Metacognitive Training
This scale has 15 items and it is a self-response questionnaire that was developed by Beck, Baruch, Balter, Steer, \& Warman in 2004 and evaluated the consciousness of the illness. The BCIS is comprised of two subscales: self-reflectiveness and self-certainty. The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty. Poorer cognitive insight is indexed by lower scores on the self-reflectiveness subscale, higher self-certainty scores, and lower BCIS composite index scores. Step 1. Score every item on the BCIS from "0" to "3" according to the following rule: * "Do Not Agree at All" = 0 * "Agree Slightly" = 1 * "Agree a Lot" = 2 * "Agree Completely" = 3 (in process of validation to Portuguese population by investigators of this study)
Beck Cognitive Insight Scale (BCIS) - moment 2
时间窗: BCIS will be applied up to 1 week after eight session of the MCT, to both groups
This scale has 15 items and it is a self-response questionnaire that was developed by Beck, Baruch, Balter, Steer, \& Warman in 2004 and evaluated the consciousness of the illness. The BCIS is comprised of two subscales: self-reflectiveness and self-certainty. The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty. Poorer cognitive insight is indexed by lower scores on the self-reflectiveness subscale, higher self-certainty scores, and lower BCIS composite index scores. Step 1. Score every item on the BCIS from "0" to "3" according to the following rule: * "Do Not Agree at All" = 0 * "Agree Slightly" = 1 * "Agree a Lot" = 2 * "Agree Completely" = 3 (in process of validation to Portuguese population by investigators of this study)
World Health Disability Assessment Schedule (WHODAS 2.0) - moment 1
时间窗: WHODAS 2.0 will be applied a week before the first session of Metacognitive Training
This instrument evaluated the functionality levels and was developed by WHO. It has 12 items and it is a self-response questionnaire (validated for the Portuguese population by Moreira, Alvarelhão, Silva, Costa and Queirós in 2015).
World Health Disability Assessment Schedule (WHODAS 2.0) - moment 2
时间窗: WHODAS 2.0 will be applied up to 1 week after eight session of the MCT, to both groups
This instrument evaluated the functionality levels and was developed by WHO. It has 12 items and it is a self-response questionnaire (validated for the Portuguese population by Moreira, Alvarelhão, Silva, Costa and Queirós in 2015).
Personal and Social Performance Scale (PSP) - moment 1
时间窗: PSP will be applied a week before the first session of Metacognitive Training
this scale was developed by Morosini, Magliano, Brambilla, Ugolini and Pioli in 2000 and it assesses patients' social functioning with four main areas: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviours (validated for the Portuguese population by Brissos et al., 2012).
Personal and Social Performance Scale (PSP) - moment 2
时间窗: PSP will be applied up to 1 week after eight session of the MCT, to both groups
this scale was developed by Morosini, Magliano, Brambilla, Ugolini and Pioli in 2000 and it assesses patients' social functioning with four main areas: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviours (validated for the Portuguese population by Brissos et al., 2012).
Personal and Social Performance Scale (PSP) - moment 3
时间窗: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
this scale was developed by Morosini, Magliano, Brambilla, Ugolini and Pioli in 2000 and it assesses patients' social functioning with four main areas: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviours (validated for the Portuguese population by Brissos et al., 2012).
World Health Disability Assessment Schedule (WHODAS 2.0) - moment 3
时间窗: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
This instrument evaluated the functionality levels and was developed by WHO. It has 12 items and it is a self-response questionnaire (validated for the Portuguese population by Moreira, Alvarelhão, Silva, Costa and Queirós in 2015).
次要结局
未报告次要终点
研究者
Carme Ferré Grau
Professor
University Rovira i Virgili