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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Fatigue Management Therapy; Other: TAU (Treatment as usual)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Delphine Capdevielle; Phone Number: +33467339702; Email: d-capdevielle@chu-montpellier.fr
• Study Contact Backup: Name: Stéphane Raffard; Email: s-raffard@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ENERGY intervention; 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; 14 sessions of 1h CBT intervention
OTHER: Treatment as usual (TAU); Comparison group; TAU defined by antipsychotic medication coupled with day hospital care	Other: TAU (Treatment as usual); No CBT intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Syndrome Scale (PANSS)	PANSS - 30 item scale assessing level of symptomatology (positive, negative, general psychopathology) in psychotic disorders	baseline - 3 months - 9 months
Clinical Assessment Interview for Negative Symptoms (CAINS)	CAINS - semi-structured interview measuring level of severity of negative symptoms	baseline - 3 months - 9 months
Calgary Depression Scale for Schizophrenia (CDSS)	CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations	baseline - 3 months - 9 months
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	baseline - 3 months - 9 months
Idiopathic Hypersomnia Severity Scale (IHSS)	IHSS - self-report measure of 14 items assessing - hypersomnolence symptoms, consequences, and responsiveness to treatment	baseline - 3 months - 9 months
Sleep Condition Indicator (SCI)	SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria	baseline - 3 months - 9 months
International Physical Activity Questionnaire short form (IPAQ)	IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia	baseline - 3 months - 9 months
Quality of life (S-QoL)	(S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations	baseline - 3 months - 9 months
Functional Remission of General Schizophrenia (FROGS)	FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations	baseline - 3 months - 9 months
Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)	IMI-SR - self-report scale with 21 items evaluating intrinsic motivation in schizophrenic populations	baseline - 3 months - 9 months
French National Adult Reading Test (fNART)	fNART - test used in assessing intellectual levels within French speaking populations	baseline - 9 months
California Verbal Learning Test (CVLT)	CVLT - neuropsychological assessment evaluating episodic verbal learning and memory	baseline - 9 months
Trail Making Test (TMT)	TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility)	baseline - 9 months
Pedometer	Pedometer - electronic portable device - assessment of distance travelled -	baseline - 3 months - 9 months (each time pedometer will be worn during one week)
Physical examinations (PE) and vital signs (VS)	PE includes - weight, BMI, abdominal perimeter VS includes: heart rate, and arterial blood pressure	baseline - 3 months - 9 months
Blood samples	lipids, glycaemia, CRP (C-reactive protein)	baseline - 3 months - 9 months
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)	baseline - 3 months - 9 months
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	baseline - 3 months - 9 months
Letter-Number Sequencing subtest (LNS)	good predictor of fluid intelligence and strongly correlates with laboratory working memory measures.	baseline - 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity agenda	level of activities performed will be monitored through weekly agendas	baseline - 3 months - 9 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Université Montpellier

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2022
• Primary Completion (ANTICIPATED): November 1, 2025
• Study Completion (ANTICIPATED): November 1, 2025

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: fatigue; schizophrenia; cognitive behavioral therapy; microbiota
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Fatigue; Schizophrenia
• Other Study ID Numbers: 7778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No