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Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia (ENERGY)

Primary Purpose

Schizophrenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fatigue Management Therapy
TAU (Treatment as usual)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring fatigue, schizophrenia, microbiota, cognitive behavioral therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Aged between 18 and 60 years,
  2. patients with a diagnosis of schizophrenia according to DSM 5 validated after a clinical evaluation by one psychiatrist investigators,
  3. patients with a score at the 4th subscale of "Multidimensional Fatigue Inventory " greater or equal to 10
  4. patients with a follow-up in a day hospital at inclusion,
  5. subjects must be able to attend all scheduled visits and comply with all trial procedures,

Non inclusion criteria:

  1. subject unable to read or/and write French,
  2. planned long-term stay outside of the study region that prevents compliance with the visit plan,
  3. patients with a history of severe brain trauma,
  4. patients with a history of neurological pathology,
  5. patients pregnant or breast-feeding
  6. patients deprived of liberty
  7. patients participating in another ongoing biomedical study
  8. patients not affiliated with a French social security scheme or beneficiary of such a scheme
  9. Absence of signed informed consent form by the patient and the patient's tutor if he has one

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    ENERGY intervention

    Treatment as usual (TAU)

    Arm Description

    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

    Comparison group TAU defined by antipsychotic medication coupled with day hospital care

    Outcomes

    Primary Outcome Measures

    Multidimensional Fatigue Inventory (MFI)
    MFI - self-assessment instrument with 20 items including 5 dimensions: General, Physical, and Mental Fatigue, Reduced Motivation and Reduced Activity

    Secondary Outcome Measures

    Positive and Negative Syndrome Scale (PANSS)
    PANSS - 30 item scale assessing level of symptomatology (positive, negative, general psychopathology) in psychotic disorders
    Clinical Assessment Interview for Negative Symptoms (CAINS)
    CAINS - semi-structured interview measuring level of severity of negative symptoms
    Calgary Depression Scale for Schizophrenia (CDSS)
    CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations
    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
    Idiopathic Hypersomnia Severity Scale (IHSS)
    IHSS - self-report measure of 14 items assessing - hypersomnolence symptoms, consequences, and responsiveness to treatment
    Sleep Condition Indicator (SCI)
    SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria
    International Physical Activity Questionnaire short form (IPAQ)
    IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia
    Quality of life (S-QoL)
    (S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations
    Functional Remission of General Schizophrenia (FROGS)
    FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations
    Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
    IMI-SR - self-report scale with 21 items evaluating intrinsic motivation in schizophrenic populations
    French National Adult Reading Test (fNART)
    fNART - test used in assessing intellectual levels within French speaking populations
    California Verbal Learning Test (CVLT)
    CVLT - neuropsychological assessment evaluating episodic verbal learning and memory
    Trail Making Test (TMT)
    TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility)
    Pedometer
    Pedometer - electronic portable device - assessment of distance travelled -
    Physical examinations (PE) and vital signs (VS)
    PE includes - weight, BMI, abdominal perimeter VS includes: heart rate, and arterial blood pressure
    Blood samples
    lipids, glycaemia, CRP (C-reactive protein)
    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)
    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
    Letter-Number Sequencing subtest (LNS)
    good predictor of fluid intelligence and strongly correlates with laboratory working memory measures.

    Full Information

    First Posted
    March 11, 2020
    Last Updated
    January 28, 2022
    Sponsor
    University Hospital, Montpellier
    Collaborators
    Université Montpellier, Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04332601
    Brief Title
    Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia
    Acronym
    ENERGY
    Official Title
    Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia: a Randomized Controlled Multi-centric Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2022 (Anticipated)
    Primary Completion Date
    November 2025 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier
    Collaborators
    Université Montpellier, Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    fatigue, schizophrenia, microbiota, cognitive behavioral therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ENERGY intervention
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Treatment as usual (TAU)
    Arm Type
    Other
    Arm Description
    Comparison group TAU defined by antipsychotic medication coupled with day hospital care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Fatigue Management Therapy
    Intervention Description
    14 sessions of 1h CBT intervention
    Intervention Type
    Other
    Intervention Name(s)
    TAU (Treatment as usual)
    Intervention Description
    No CBT intervention
    Primary Outcome Measure Information:
    Title
    Multidimensional Fatigue Inventory (MFI)
    Description
    MFI - self-assessment instrument with 20 items including 5 dimensions: General, Physical, and Mental Fatigue, Reduced Motivation and Reduced Activity
    Time Frame
    Change between baseline and 3 months later (corresponding to the end of the treatment intervention)
    Secondary Outcome Measure Information:
    Title
    Positive and Negative Syndrome Scale (PANSS)
    Description
    PANSS - 30 item scale assessing level of symptomatology (positive, negative, general psychopathology) in psychotic disorders
    Time Frame
    baseline - 3 months - 9 months
    Title
    Clinical Assessment Interview for Negative Symptoms (CAINS)
    Description
    CAINS - semi-structured interview measuring level of severity of negative symptoms
    Time Frame
    baseline - 3 months - 9 months
    Title
    Calgary Depression Scale for Schizophrenia (CDSS)
    Description
    CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations
    Time Frame
    baseline - 3 months - 9 months
    Title
    Berlin Questionnaire (BQ)
    Description
    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
    Time Frame
    baseline - 3 months - 9 months
    Title
    Idiopathic Hypersomnia Severity Scale (IHSS)
    Description
    IHSS - self-report measure of 14 items assessing - hypersomnolence symptoms, consequences, and responsiveness to treatment
    Time Frame
    baseline - 3 months - 9 months
    Title
    Sleep Condition Indicator (SCI)
    Description
    SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria
    Time Frame
    baseline - 3 months - 9 months
    Title
    International Physical Activity Questionnaire short form (IPAQ)
    Description
    IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia
    Time Frame
    baseline - 3 months - 9 months
    Title
    Quality of life (S-QoL)
    Description
    (S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations
    Time Frame
    baseline - 3 months - 9 months
    Title
    Functional Remission of General Schizophrenia (FROGS)
    Description
    FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations
    Time Frame
    baseline - 3 months - 9 months
    Title
    Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
    Description
    IMI-SR - self-report scale with 21 items evaluating intrinsic motivation in schizophrenic populations
    Time Frame
    baseline - 3 months - 9 months
    Title
    French National Adult Reading Test (fNART)
    Description
    fNART - test used in assessing intellectual levels within French speaking populations
    Time Frame
    baseline - 9 months
    Title
    California Verbal Learning Test (CVLT)
    Description
    CVLT - neuropsychological assessment evaluating episodic verbal learning and memory
    Time Frame
    baseline - 9 months
    Title
    Trail Making Test (TMT)
    Description
    TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility)
    Time Frame
    baseline - 9 months
    Title
    Pedometer
    Description
    Pedometer - electronic portable device - assessment of distance travelled -
    Time Frame
    baseline - 3 months - 9 months (each time pedometer will be worn during one week)
    Title
    Physical examinations (PE) and vital signs (VS)
    Description
    PE includes - weight, BMI, abdominal perimeter VS includes: heart rate, and arterial blood pressure
    Time Frame
    baseline - 3 months - 9 months
    Title
    Blood samples
    Description
    lipids, glycaemia, CRP (C-reactive protein)
    Time Frame
    baseline - 3 months - 9 months
    Title
    Microbial translocation
    Description
    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)
    Time Frame
    baseline - 3 months - 9 months
    Title
    Inflammatory status
    Description
    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
    Time Frame
    baseline - 3 months - 9 months
    Title
    Letter-Number Sequencing subtest (LNS)
    Description
    good predictor of fluid intelligence and strongly correlates with laboratory working memory measures.
    Time Frame
    baseline - 9 months
    Other Pre-specified Outcome Measures:
    Title
    Activity agenda
    Description
    level of activities performed will be monitored through weekly agendas
    Time Frame
    baseline - 3 months - 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Delphine Capdevielle
    Phone
    +33467339702
    Email
    d-capdevielle@chu-montpellier.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stéphane Raffard
    Email
    s-raffard@chu-montpellier.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32943079
    Citation
    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.
    Results Reference
    derived

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