Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia: a Randomized Controlled Multi-centric Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Fatigue Management Therapy
* Other: TAU (Treatment as usual)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENERGY intervention<br>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 | Behavioral: Fatigue Management Therapy<br>* 14 sessions of 1h CBT intervention<br>|
| Other: Treatment as usual (TAU)<br>Comparison group TAU defined by antipsychotic medication coupled with day hospital care | Other: TAU (Treatment as usual)<br>* No CBT intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Fatigue Inventory (MFI) | MFI - self-assessment instrument with 20 items including 5 dimensions: General, Physical, and Mental Fatigue, Reduced Motivation and Reduced Activity | Change between baseline and 3 months later (corresponding to the end of the treatment intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) | PANSS - 30 item scale assessing level of symptomatology (positive, negative, general psychopathology) in psychotic disorders | baseline - 3 months - 9 months | 
| Clinical Assessment Interview for Negative Symptoms (CAINS) | CAINS - semi-structured interview measuring level of severity of negative symptoms | baseline - 3 months - 9 months | 
| Calgary Depression Scale for Schizophrenia (CDSS) | CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations | baseline - 3 months - 9 months | 
| Berlin Questionnaire (BQ) | BQ- questionnaire consisting of 3 categories related to the risk of having sleep apnea; snoring (section 1), daytime somnolence (section 2), and hypertension and BMI (section 3 | baseline - 3 months - 9 months | 
| Idiopathic Hypersomnia Severity Scale (IHSS) | IHSS - self-report measure of 14 items assessing - hypersomnolence symptoms, consequences, and responsiveness to treatment | baseline - 3 months - 9 months | 
| Sleep Condition Indicator (SCI) | SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria | baseline - 3 months - 9 months | 
| International Physical Activity Questionnaire short form (IPAQ) | IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia | baseline - 3 months - 9 months | 
| Quality of life (S-QoL) | (S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations | baseline - 3 months - 9 months | 
| Functional Remission of General Schizophrenia (FROGS) | FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations | baseline - 3 months - 9 months | 
| Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR) | IMI-SR - self-report scale with 21 items evaluating intrinsic motivation in schizophrenic populations | baseline - 3 months - 9 months | 
| French National Adult Reading Test (fNART) | fNART - test used in assessing intellectual levels within French speaking populations | baseline - 9 months | 
| California Verbal Learning Test (CVLT) | CVLT - neuropsychological assessment evaluating episodic verbal learning and memory | baseline - 9 months | 
| Trail Making Test (TMT) | TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility) | baseline - 9 months | 
| Pedometer | Pedometer - electronic portable device - assessment of distance travelled - | baseline - 3 months - 9 months (each time pedometer will be worn during one week) | 
| Physical examinations (PE) and vital signs (VS) | PE includes - weight, BMI, abdominal perimeter VS includes: heart rate, and arterial blood pressure | baseline - 3 months - 9 months | 
| Blood samples | lipids, glycaemia, CRP (C-reactive protein) | baseline - 3 months - 9 months | 
| Microbial translocation | DNA extraction and analyze of LBP (Lipopolysaccharide Binding Protein), CD14s, l'I-FABP (fatty acid-binding proteins), zonulin, real-time PCR (polymerase chain reaction) analysis (DNA16s) | baseline - 3 months - 9 months | 
| Inflammatory status | GM-CSF (granulocyte-macrophage colony-stimulating factor), IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α | baseline - 3 months - 9 months | 
| Letter-Number Sequencing subtest (LNS) | good predictor of fluid intelligence and strongly correlates with laboratory working memory measures. | baseline - 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, schizophrenia, microbiota, cognitive behavioral therapy