Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

NCT04332601 | Unknown

• 1 other identifier: 7778
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

fatigue; schizophrenia; microbiota; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (19)

• Positive and Negative Syndrome Scale (PANSS)

  baseline - 3 months - 9 months

• Clinical Assessment Interview for Negative Symptoms (CAINS)

  baseline - 3 months - 9 months

• Calgary Depression Scale for Schizophrenia (CDSS)

  baseline - 3 months - 9 months

• Berlin Questionnaire (BQ)

  baseline - 3 months - 9 months

• Idiopathic Hypersomnia Severity Scale (IHSS)

  baseline - 3 months - 9 months

Other Outcomes (1)

• Activity agenda

  baseline - 3 months - 9 months

Study Arms (2)

ENERGY intervention

EXPERIMENTAL

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

Treatment as usual (TAU)

OTHER

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

Other: TAU (Treatment as usual)

Interventions

Fatigue Management Therapy BEHAVIORAL

14 sessions of 1h CBT intervention

ENERGY intervention

TAU (Treatment as usual) OTHER

No CBT intervention

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• subjects must be able to attend all scheduled visits and comply with all trial procedures,
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Related Publications (1)

• 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.

  PMID: 32943079 DERIVED

MeSH Terms

Conditions

Schizophrenia; Fatigue

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Delphine Capdevielle

CONTACT

+33467339702; d-capdevielle@chu-montpellier.fr

Stéphane Raffard

CONTACT

s-raffard@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: April 2, 2020
• Study Start: February 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 11, 2022

Record last verified: 2022-01