Randomized, Controlled Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change of at least one class at the Lille Apathy Rating Scale (LARS) at 3 months
研究概览
简要总结
Schizophrenia is a mental pathology that concerns 1% of the French population, characterized by heterogeneity of symptoms. One of them, apathy is defined as a multidimensional psychopathological state manifested by a decrease in motivation. This deficit is most common in schizophrenia and impacts the functional outcome of patients. To date, no treatment has shown a significant effect on this symptom. In other pathologies with a motivational deficit, the technique of Mental Contrasting and Implementation Intention (CM-II) showed interesting effects in improving motivation, reducing the effort related to the action.
The investigators aim to propose the CM-II technique to individuals with schizophrenia to improve apathy.
The investigators expected that the CM-II technique will allow an improvement of apathy which will have beneficial effects on other psychological factors (e.g., depressive symptoms). In addition, the implementation of the CM-II will provide help to global management.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and < 60 years old
- •Diagnosis of schizophrenia according to DSM 5 criteria.
- •Score greater than or equal to -18 on the Lille Apathy Rating Scale
- •Ability to understand and speak French.
- •Obligation to belong to or be a beneficiary of a social security scheme.
- •Signature of the consent. If the participant has a representative, signature by the representative.
排除标准
- •History of head injuries or neurological pathologies.
- •Current treatment with sismotherapy or repetitive Transcranial Magnetic Stimulation (rTMS).
- •Treatment targeted at and/or influencing negative symptoms (CBT, cognitive remediation), or therapeutic trial.
- •Participant under safeguard of justice.
- •Pregnant or breastfeeding woman.
结局指标
主要结局
Change of at least one class at the Lille Apathy Rating Scale (LARS) at 3 months
时间窗: Change between Baseline and 3 months
LARS (Sockeel et al. 2006, translated and validated in French by Yazbek et al. 2014) is a questionnaire semi-structured based on a multidimensional approach to apathy. It is composed of 33 grouped items in nine dimensions: activities of daily living, interests, taking initiative, interest in novelty, voluntary efforts, the intensity of emotions, worry, social life, and self-critical capability. Each item can be rated at 1 (no) or -1 (yes), a score of 0 is possible. if the answer is not classifiable. The total score on this scale ranges from -36 to +36 and allows for different classes: non-apathetic (score -36 to -22); tendency to apathy (-21 to -17); moderate apathy (-16 to -10); and severe apathy (-9 to +36).
次要结局
- the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 1 month(Change between Baseline and 1 month)
- the improvement of at least one class at the Lille Apathy Rating Scale (LARS) at 6 months(Change between Baseline and 6 months)
- Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 1 month(Change between Baseline and 1 month)
- Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 3 months(Change between Baseline and 3 months)
- Improvement of the score at the Calgary Depression Scale for Schizophrenia (CDSS) at 6 months(Change between Baseline and 6 months)
- Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 1 month(Change between Baseline and 1 month)
- increased percentage of personal goal attainment at 1 month(Change between Baseline and 1 month)
- increased percentage of personal goal attainment at 3 months(Change between Baseline and 3 months)
- Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 3 months(Change between Baseline and 3 months)
- Improvement in the " negative symptoms " sub-score of the Positive And Negative Syndrome Scale (PANSS, Kay et al., 1987) at 6 months(Change between Baseline and 6 months)
- increased percentage of personal goal attainment at 6 months(Change between Baseline and 6 months)
- Decreased perception of effort associated with achieving goals at 1 month(Change between Baseline and 1 month)
- Decreased perception of effort associated with achieving goals at 3 months(Change between Baseline and 3 months)
- Decreased perception of effort associated with achieving goals at 6 months(Change between Baseline and 6 months)