Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia

• Registration Number: NCT04332601
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Study Start: 2022-02
• Last Update Posted: 2022-02-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Multidimensional Fatigue Inventory (MFI)	Change between baseline and 3 months later (corresponding to the end of the treatment intervention)	MFI - self-assessment instrument with 20 items including 5 dimensions: General, Physical, and Mental Fatigue, Reduced Motivation and Reduced Activity

Secondary Outcome Measures

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