Clinical trial NCT04332601: Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia
Official title: Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia: a Randomized Controlled Multi-centric Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: fatigue
schizophrenia
microbiota
cognitive behavioral therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-04-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Change between baseline and 3 months later (corresponding to the end of the treatment intervention)
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: baseline - 3 months - 9 months
measure: Clinical Assessment Interview for Negative Symptoms (CAINS)
timeFrame: baseline - 3 months - 9 months
measure: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: baseline - 3 months - 9 months
measure: Berlin Questionnaire (BQ)
timeFrame: baseline - 3 months - 9 months
measure: Idiopathic Hypersomnia Severity Scale (IHSS)
timeFrame: baseline - 3 months - 9 months
measure: Sleep Condition Indicator (SCI)
timeFrame: baseline - 3 months - 9 months
measure: International Physical Activity Questionnaire short form (IPAQ)
timeFrame: baseline - 3 months - 9 months
measure: Quality of life (S-QoL)
timeFrame: baseline - 3 months - 9 months
measure: Functional Remission of General Schizophrenia (FROGS)
timeFrame: baseline - 3 months - 9 months
measure: Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
timeFrame: baseline - 3 months - 9 months
measure: French National Adult Reading Test (fNART)
timeFrame: baseline - 9 months
measure: California Verbal Learning Test (CVLT)
timeFrame: baseline - 9 months
measure: Trail Making Test (TMT)
timeFrame: baseline - 9 months
measure: Pedometer
timeFrame: baseline - 3 months - 9 months (each time pedometer will be worn during one week)
measure: Physical examinations (PE) and vital signs (VS)
timeFrame: baseline - 3 months - 9 months
measure: Blood samples
timeFrame: baseline - 3 months - 9 months
measure: Microbial translocation
timeFrame: baseline - 3 months - 9 months
measure: Inflammatory status
timeFrame: baseline - 3 months - 9 months
measure: Letter-Number Sequencing subtest (LNS)
timeFrame: baseline - 9 months
Other outcomes:
measure: Activity agenda
timeFrame: baseline - 3 months - 9 months
Locations:
Study officials:
References:
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.