Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia: a Randomized Controlled Multi-centric Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Multidimensional Fatigue Inventory (MFI)
研究概览
简要总结
Fatigue is commonly experienced in numerous pathologies, including schizophrenia. Research has shown that chronic fatigue can exacerbate clinical symptoms.
Several evidence-based interventions for fatigue syndrome have been shown to be effective in other medical conditions, but up to this date no research has assessed interventions in fatigue management within psychotic populations.
The aim of this study is to evaluate (in a multisite single blind randomized clinical trial) the efficacy of a cognitive-behavioral therapy (CBT) intervention of fatigue management in people diagnosed with schizophrenia. Secondary objectives include the examination of changes in fatigue scores as well as clinical symptoms, physical & cognitive functioning, quality of life at 9-month post CBT intervention. Another aim in this study is to assess - MICROBIATE
The investigators hypothesize that following the CBT treatment intervention, patients will demonstrate reduced level of fatigue. No change in the severity of fatigue is expected in the group receiving treatment as usual.
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
- Double (Investigator, 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
- •Aged between 18 and 60 years,
- •patients with a diagnosis of schizophrenia according to DSM 5 validated after a clinical evaluation by one psychiatrist investigators,
- •patients with a score at the 4th subscale of "Multidimensional Fatigue Inventory " greater or equal to 10
- •patients with a follow-up in a day hospital at inclusion,
- •subjects must be able to attend all scheduled visits and comply with all trial procedures,
- •Non inclusion criteria:
- •subject unable to read or/and write French,
- •planned long-term stay outside of the study region that prevents compliance with the visit plan,
- •patients with a history of severe brain trauma,
- •patients with a history of neurological pathology,
- •patients pregnant or breast-feeding
- •patients deprived of liberty
- •patients participating in another ongoing biomedical study
- •patients not affiliated with a French social security scheme or beneficiary of such a scheme
- •Absence of signed informed consent form by the patient and the patient's tutor if he has one
排除标准
- 未提供
研究组 & 干预措施
ENERGY intervention
ENERGY Intervention:
- 14 sessions of 1h CBT intervention (standardized fatigue treatment comprising six modules over 14 individual therapy sessions)
- 1 session per week
- With a psychologist (different to the psychologist who will perform the assessments)
- Individual sessions
- and Treatment as usual
干预措施: Fatigue Management Therapy (Behavioral)
Treatment as usual (TAU)
- Comparison group
- TAU defined by antipsychotic medication coupled with day hospital care
干预措施: TAU (Treatment as usual) (Other)
结局指标
主要结局
Multidimensional Fatigue Inventory (MFI)
时间窗: Change between baseline and 3 months later (corresponding to the end of the treatment intervention)
MFI - self-assessment instrument with 20 items including 5 dimensions: General, Physical, and Mental Fatigue, Reduced Motivation and Reduced Activity
次要结局
- Microbial translocation(baseline - 3 months - 9 months)
- Inflammatory status(baseline - 3 months - 9 months)
- Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)(baseline - 3 months - 9 months)
- Idiopathic Hypersomnia Severity Scale (IHSS)(baseline - 3 months - 9 months)
- Sleep Condition Indicator (SCI)(baseline - 3 months - 9 months)
- Clinical Assessment Interview for Negative Symptoms (CAINS)(baseline - 3 months - 9 months)
- International Physical Activity Questionnaire short form (IPAQ)(baseline - 3 months - 9 months)
- California Verbal Learning Test (CVLT)(baseline - 9 months)
- Physical examinations (PE) and vital signs (VS)(baseline - 3 months - 9 months)
- Quality of life (S-QoL)(baseline - 3 months - 9 months)
- Functional Remission of General Schizophrenia (FROGS)(baseline - 3 months - 9 months)
- Berlin Questionnaire (BQ)(baseline - 3 months - 9 months)
- French National Adult Reading Test (fNART)(baseline - 9 months)
- Trail Making Test (TMT)(baseline - 9 months)
- Pedometer(baseline - 3 months - 9 months (each time pedometer will be worn during one week))
- Blood samples(baseline - 3 months - 9 months)
- Positive and Negative Syndrome Scale (PANSS)(baseline - 3 months - 9 months)
- Calgary Depression Scale for Schizophrenia (CDSS)(baseline - 3 months - 9 months)
- Letter-Number Sequencing subtest (LNS)(baseline - 9 months)