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SchizophreniaENERGYNCT04332601

Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

A study testing Fatigue Management Therapy and TAU (Treatment as usual) in people with Schizophrenia, run by University Hospital, Montpellier.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Fatigue Management Therapy and TAU (Treatment as usual)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Feb 2022to Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet.

Delphine Capdevielle contact

+33467339702

d-capdevielle@chu-montpellier.fr

Stéphane Raffard contact

s-raffard@chu-montpellier.fr

About this study

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

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.

Read more

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.

Conditions
Schizophrenia
Being tested
Fatigue Management Therapy, TAU (Treatment as usual)
Keywords
fatigue, schizophrenia, microbiota, cognitive behavioral therapy
Medical subject headings
Schizophrenia, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fatigue Management TherapyBehavioural

    14 sessions of 1h CBT intervention

  • TAU (Treatment as usual)Other

    No CBT intervention

Study groups in NCT04332601
Study groupRoleWhat they receive
ENERGY interventionExperimentalENERGY 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
Receives: Behavioral: Fatigue Management Therapy
Treatment as usual (TAU)Other* Comparison group * TAU defined by antipsychotic medication coupled with day hospital care
Receives: Other: TAU (Treatment as usual)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Multidimensional Fatigue Inventory (MFI)

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

    Measured: Change between baseline and 3 months later (corresponding to the end of the treatment intervention)

Secondary outcomes (19)

  1. Positive and Negative Syndrome Scale (PANSS)

    PANSS - 30 item scale assessing level of symptomatology (positive, negative, general psychopathology) in psychotic disorders

    Measured: baseline - 3 months - 9 months

  2. Clinical Assessment Interview for Negative Symptoms (CAINS)

    CAINS - semi-structured interview measuring level of severity of negative symptoms

    Measured: baseline - 3 months - 9 months

  3. Calgary Depression Scale for Schizophrenia (CDSS)

    CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations

    Measured: baseline - 3 months - 9 months

  4. 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

    Measured: baseline - 3 months - 9 months

  5. Idiopathic Hypersomnia Severity Scale (IHSS)

    IHSS - self-report measure of 14 items assessing - hypersomnolence symptoms, consequences, and responsiveness to treatment

    Measured: baseline - 3 months - 9 months

  6. Sleep Condition Indicator (SCI)

    SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria

    Measured: baseline - 3 months - 9 months

  7. International Physical Activity Questionnaire short form (IPAQ)

    IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia

    Measured: baseline - 3 months - 9 months

  8. Quality of life (S-QoL)

    (S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations

    Measured: baseline - 3 months - 9 months

  9. Functional Remission of General Schizophrenia (FROGS)

    FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations

    Measured: baseline - 3 months - 9 months

  10. Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)

    IMI-SR - self-report scale with 21 items evaluating intrinsic motivation in schizophrenic populations

    Measured: baseline - 3 months - 9 months

  11. French National Adult Reading Test (fNART)

    fNART - test used in assessing intellectual levels within French speaking populations

    Measured: baseline - 9 months

  12. California Verbal Learning Test (CVLT)

    CVLT - neuropsychological assessment evaluating episodic verbal learning and memory

    Measured: baseline - 9 months

  13. Trail Making Test (TMT)

    TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility)

    Measured: baseline - 9 months

  14. Pedometer

    Pedometer - electronic portable device - assessment of distance travelled -

    Measured: baseline - 3 months - 9 months (each time pedometer will be worn during one week)

  15. Physical examinations (PE) and vital signs (VS)

    PE includes - weight, BMI, abdominal perimeter VS includes: heart rate, and arterial blood pressure

    Measured: baseline - 3 months - 9 months

  16. Blood samples

    lipids, glycaemia, CRP (C-reactive protein)

    Measured: baseline - 3 months - 9 months

  17. 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)

    Measured: baseline - 3 months - 9 months

  18. 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

    Measured: baseline - 3 months - 9 months

  19. Letter-Number Sequencing subtest (LNS)

    good predictor of fluid intelligence and strongly correlates with laboratory working memory measures.

    Measured: baseline - 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study startFeb 2022 (estimated)
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04332601
Sponsor's protocol ID
7778
Acronym
ENERGY
Status last verified
Jan 2022
First submitted
11 Mar 2020
Last updated
11 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32943079

Questions about this trial

What is this clinical trial studying?

A study testing Fatigue Management Therapy and TAU (Treatment as usual) in people with Schizophrenia, run by University Hospital, Montpellier.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Delphine Capdevielle (+33467339702, d-capdevielle@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multidimensional Fatigue Inventory (MFI) (time frame: Change between baseline and 3 months later (corresponding to the end of the treatment intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04332601, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.

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