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| Name | Class |
|---|---|
| Université Montpellier | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENERGY intervention | Experimental | ENERGY Intervention:
|
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| Treatment as usual (TAU) | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fatigue Management Therapy | Behavioral | 14 sessions of 1h CBT intervention |
| |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Activity agenda | level of activities performed will be monitored through weekly agendas | baseline - 3 months - 9 months |
Inclusion criteria:
Non inclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine Capdevielle | Contact | +33467339702 | d-capdevielle@chu-montpellier.fr | |
| Stéphane Raffard | Contact | s-raffard@chu-montpellier.fr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32943079 | Derived | Raffard S, Rainteau N, Bayard S, Laraki Y, Norton J, Capdevielle D. Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY). Trials. 2020 Sep 17;21(1):797. doi: 10.1186/s13063-020-04606-6. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| TAU (Treatment as usual) |
| Other |
No CBT intervention |
|
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 |