Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Mean Change in Insight Scores as measured by The Beck Cognitive Insight Scale (BCIS)
研究概览
简要总结
The aim of this study is to explore new safe effective psychotherapeutic interventions for schizophrenia through assessing the efficacy and acceptability of complementary "Insight Enhancement Program" (IEP) and "Metacognitive Training for Psychosis" (MCT), in relation to each other, and in relation to "Treatment As Usual" (TAU). It is hypothesized that at the end of therapy, compared to "Treatment As Usual", patients undergoing whether (IEP) or (MCT) will display a significant reduction in psychopathology particularly positive symptoms and delusional ideation, and a significant improvement in Insight and metacognitive capacity. Additionally, it is hypothesized that the acceptance of (IEP) and (MCT) will be higher than acceptance of (TAU). This study also aims to examine whether metacognition is associated with insight even after controlling for the effects of psychiatric symptomatology.
详细描述
Specific aims include:
- Aim #1: Evaluate the efficacy of complementary "Insight Enhancement Program" (IEP), compared to TAU, in reducing psychopathology particularly positive symptoms and delusional ideation, and improving insight and metacognitive capacity as well as social functioning.
- Aim #2: Evaluate the efficacy of complementary "Metacognitive Training for Psychosis" (MCT), compared to TAU, in reducing psychopathology particularly positive symptoms and delusional ideation, and improving insight and metacognitive capacity as well as social functioning.
- Aim #3: Compare the efficacy of complementary "Insight Enhancement Program" (IEP), compared to "Metacognitive Training for Psychosis" (MCT), in reducing psychopathology and improving insight and metacognitive capacity as well as social functioning.
- Aim #4: Examine the associations between insight, metacognition, and psychopathology.
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
Assessors will be blind to treatment allocation, and specific measures will be undertaken to preserve blinding and prevent a Rosenthal effect (e.g., assessors will not be employees of the same hospital, and before each assessment participants will be explicitly instructed not to disclose their group assignment to the assessor).
Randomization will be according to a randomization plan using stratified permuted block randomization with each block containing four participants. This method will be used to achieve balance among groups in terms of subjects' baseline characteristics. Stratified randomization is achieved by generating a separate block for each covariate such as age & gender.
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
- •A diagnosis of a Schizophrenia Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5).
- •A present or prior episode of delusional symptoms, as assessed via clinical interview.
- •Within the first five years since the onset of psychosis.
- •Age between 18 and 65 years.
- •Egyptian Nationality.
- •Fluent command of the Arabic language.
- •Capacity to understand the study description and provide informed consent.
- •In order to examine the efficacy of IEP and MCT in cases with minor symptom load, no minimum symptom threshold was defined for inclusion.
排除标准
- •Comorbid Substance Dependence Disorder.
- •Comorbid medical conditions, whose pathology or treatment could alter the presentation or treatment of schizophrenia.
- •Intellectual disability (IQ of less than 70).
- •Known sensitivity to Risperidone.
- •Pregnant or Breast feeding women.
- •Scores of 5 or higher on the PANSS hostility item and of 6 or higher on PANSS suspiciousness item (As group settings can be disrupted by behavioral disturbances, patients with very severe forms of delusions, formal thought disorder and hostility should refrain from participating in MCT or IEP until some remission has taken place).
研究组 & 干预措施
Insight Enhancement Program (IEP)
The insight enhancement program is a dynamo-cognitive therapeutic modality with the main target of improving insight in psychotic patients as a means of improving their overall outcome.
干预措施: Insight Enhancement Program (IEP) (Behavioral)
Insight Enhancement Program (IEP)
The insight enhancement program is a dynamo-cognitive therapeutic modality with the main target of improving insight in psychotic patients as a means of improving their overall outcome.
干预措施: Treatment As Usual (TAU) (Drug)
Metacognitive Training for Psychosis (MCT)
The metacognitive training program, developed by Moritz et al. (Moritz & Woodward, 2007) targets cognitive biases putatively involved in the formation and maintenance of psychotic symptoms.
干预措施: Metacognitive Training for Psychosis (MCT) (Behavioral)
Metacognitive Training for Psychosis (MCT)
The metacognitive training program, developed by Moritz et al. (Moritz & Woodward, 2007) targets cognitive biases putatively involved in the formation and maintenance of psychotic symptoms.
干预措施: Treatment As Usual (TAU) (Drug)
Treatment As Usual (TAU)
Treatment as usual will be used as a control condition to assure ethicality of our procedure.
Medications: In order to standardize treatment, Risperidone (Risperdal ) will be used as the antipsychotic medication in all three groups with a dose up to 6-8 milligrams according to clinical severity. The same dose will be used for 1 month prior to starting interventions). In case of occurrence of mild extrapyramidal symptoms associated with high doses of risperidone, an anticholinergic drug (Benztropine) might be used.
干预措施: Treatment As Usual (TAU) (Drug)
结局指标
主要结局
Mean Change in Insight Scores as measured by The Beck Cognitive Insight Scale (BCIS)
时间窗: Pre-Intervention at Week 4, and Post-Intervention at Week 8
The BCIS is a self-report consisting of 15 statements rated on a 4-point Likert scale. It is divided into 2 subscales; self-reflectiveness, and self-certainty. Self-reflectiveness consists of 9 items measuring objectivity, reflectiveness and openness to feedback. Self-certainty consists of 6 items measuring decision-making and resistance to feedback. Overall cognitive insight was defined by Beck and associates as the difference between self-reflectiveness and self- certainty and labeled composite index.
Mean Change in Metacognition Scores as measured by The Metacognition Assessment Scale - Adapted version (MAS-A)
时间窗: Pre-Intervention at Week 4, and Post-Intervention at Week 8
The MAS-A is scored on the basis of the transcript of the Indiana Psychiatric Illness Interview (IPII). Scoring is performed by a consensus group of at least three trained raters. The four domains of metacognition are reflected in the four ordinal complexity scales of the MAS-A: self-reflectivity, understanding the other's mind, decentration, and mastery. The raters assign one point for each function on each scale that they judge is accomplished in the transcript.
Mean Change in Psychopathology as measured by The Psychotic Symptom Rating Scale (PSYRATS)
时间窗: Pre-Intervention at Week 4, and Post-Intervention at Week 8
The PSYRATS is a 17-item multidimensional measure of more qualitative aspects of hallucinations and delusions. Symptoms are rated over the past 2 weeks. Two subscales exist; for auditory hallucinations (11 items), and for delusions (6 items).
Mean Change in Psychopathology as measured by The Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
时间窗: Pre-Intervention at Week 4, and Post-Intervention at Week 8
The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) is a 30-item, seven-point (1-7) scale and it is the most widely used instrument for the assessment of schizophrenia symptoms in clinical trials. Ratings follow semi-structured interviews and clear standard operating procedures. Symptoms are rated according to their presence in the past 2 weeks. The PANSS was used many times before in trials of MCT \& insight in schizophrenia, which makes it more suitable allowing comparison of results.
Mean Change in Insight Scores as measured by The Scale to Assess Unawareness of Mental Disorder (SUMD)
时间窗: Pre-Intervention at Week 4, and Post-Intervention at Week 8
The SUMD evaluates insight into various dimensions of the disease. The SUMD is a standardized scale that relies on a direct interview with the patient.
次要结局
- Mean Change in Neuropsychological Functioning Scores as measured by The Porteus Mazes task.(Pre-Intervention at Week 4, and Post-Intervention at Week 8)
- Mean Change in Neuropsychological Functioning Scores as measured by The Digit Symbol Substitution Test (DSST)(Pre-Intervention at Week 4, and Post-Intervention at Week 8)
- Mean Change in Neuropsychological Functioning Scores as measured by The story subtest of the Rivermead Behavioural Memory Task.(Pre-Intervention at Week 4, and Post-Intervention at Week 8)
- Adverse Events will be measured by The Systematic Monitoring of Adverse Events Related to Treatments Checklist (SMARTS)(At Baseline, Week 2, Week 4, Week 6, Week 8)
- Mean Change in Scores as measured by The Personal and social performance scale (PSP)(Pre-Intervention at Week 4, and Post-Intervention at Week 8)
- Mean Change in Neuropsychological Functioning Scores as measured by The Trail making test (TMT)(Pre-Intervention at Week 4, and Post-Intervention at Week 8)
- Mean Change in IQ as measured by The Wechsler Adult Intelligence Scale (WAIS-III)(Pre-Intervention at Week 4, and Post-Intervention at Week 8)
- Mean Change in Self-Esteem Scores as measured by The Rosenberg Self-esteem Scale (RSES) - Arabic Version -(Pre-Intervention at Week 4, and Post-Intervention at Week 8)
研究者
Ahmed Ahmed Dobie
Specialist of Psychiatry
Agiad Psychiatry Hospital