Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Behavioral: Fatigue Management TherapyOther: TAU (Treatment as usual)
- Registration Number
- NCT04332601
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ENERGY intervention Fatigue Management Therapy 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 Treatment as usual (TAU) TAU (Treatment as usual) * Comparison group * TAU defined by antipsychotic medication coupled with day hospital care
- Primary Outcome Measures
Name Time Method Multidimensional Fatigue Inventory (MFI) 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
- Secondary Outcome Measures
Name Time Method Microbial translocation baseline - 3 months - 9 months 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)
Inflammatory status baseline - 3 months - 9 months 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
Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR) baseline - 3 months - 9 months IMI-SR - self-report scale with 21 items evaluating intrinsic motivation in schizophrenic populations
Berlin Questionnaire (BQ) baseline - 3 months - 9 months 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
French National Adult Reading Test (fNART) baseline - 9 months fNART - test used in assessing intellectual levels within French speaking populations
Trail Making Test (TMT) baseline - 9 months TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility)
Pedometer baseline - 3 months - 9 months (each time pedometer will be worn during one week) Pedometer - electronic portable device - assessment of distance travelled -
Blood samples baseline - 3 months - 9 months lipids, glycaemia, CRP (C-reactive protein)
Idiopathic Hypersomnia Severity Scale (IHSS) baseline - 3 months - 9 months IHSS - self-report measure of 14 items assessing - hypersomnolence symptoms, consequences, and responsiveness to treatment
Sleep Condition Indicator (SCI) baseline - 3 months - 9 months SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria
Clinical Assessment Interview for Negative Symptoms (CAINS) baseline - 3 months - 9 months CAINS - semi-structured interview measuring level of severity of negative symptoms
International Physical Activity Questionnaire short form (IPAQ) baseline - 3 months - 9 months IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia
California Verbal Learning Test (CVLT) baseline - 9 months CVLT - neuropsychological assessment evaluating episodic verbal learning and memory
Physical examinations (PE) and vital signs (VS) baseline - 3 months - 9 months PE includes - weight, BMI, abdominal perimeter VS includes: heart rate, and arterial blood pressure
Positive and Negative Syndrome Scale (PANSS) baseline - 3 months - 9 months PANSS - 30 item scale assessing level of symptomatology (positive, negative, general psychopathology) in psychotic disorders
Calgary Depression Scale for Schizophrenia (CDSS) baseline - 3 months - 9 months CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations
Quality of life (S-QoL) baseline - 3 months - 9 months (S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations
Functional Remission of General Schizophrenia (FROGS) baseline - 3 months - 9 months FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations
Letter-Number Sequencing subtest (LNS) baseline - 9 months good predictor of fluid intelligence and strongly correlates with laboratory working memory measures.