Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

Schizophrenia Clinical Trial

— ENERGY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04332601
• Other study ID #: 7778
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2022
• Est. completion date: November 2025

Study information

• Verified date: January 2022
• Source: University Hospital, Montpellier
• Contact: Delphine Capdevielle
• Phone: +33467339702
• Email: d-capdevielle[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Schizophrenia

Intervention

Behavioral:
• Fatigue Management Therapy
14 sessions of 1h CBT intervention

Other:
• TAU (Treatment as usual)
No CBT intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut National de la Santé Et de la Recherche Médicale, France, Université Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activity agenda	level of activities performed will be monitored through weekly agendas	baseline - 3 months - 9 months
Primary	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	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
Secondary	Clinical Assessment Interview for Negative Symptoms (CAINS)	CAINS - semi-structured interview measuring level of severity of negative symptoms	baseline - 3 months - 9 months
Secondary	Calgary Depression Scale for Schizophrenia (CDSS)	CDSS - 9 item scale assessing level of depressive symptomatology in schizophrenic populations	baseline - 3 months - 9 months
Secondary	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
Secondary	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
Secondary	Sleep Condition Indicator (SCI)	SCI - 8 item scale evaluating symptoms of insomnia based on DSM 5 criteria	baseline - 3 months - 9 months
Secondary	International Physical Activity Questionnaire short form (IPAQ)	IPAQ - surveillance tool assessing levels of physical activity in patients with schizophrenia	baseline - 3 months - 9 months
Secondary	Quality of life (S-QoL)	(S-QoL) - self-assessment questionnaire assessing health related quality of life in schizophrenic populations	baseline - 3 months - 9 months
Secondary	Functional Remission of General Schizophrenia (FROGS)	FROGS - 19 item questionnaire assessing level of functional remission in schizophrenic populations	baseline - 3 months - 9 months
Secondary	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
Secondary	French National Adult Reading Test (fNART)	fNART - test used in assessing intellectual levels within French speaking populations	baseline - 9 months
Secondary	California Verbal Learning Test (CVLT)	CVLT - neuropsychological assessment evaluating episodic verbal learning and memory	baseline - 9 months
Secondary	Trail Making Test (TMT)	TMT - neuropsychological assessment evaluating executive functioning (attention, visual exploration, speed, mental flexibility)	baseline - 9 months
Secondary	Pedometer	Pedometer - electronic portable device - assessment of distance travelled -	baseline - 3 months - 9 months (each time pedometer will be worn during one week)
Secondary	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
Secondary	Blood samples	lipids, glycaemia, CRP (C-reactive protein)	baseline - 3 months - 9 months
Secondary	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
Secondary	Inflammatory status	GM-CSF (granulocyte-macrophage colony-stimulating factor), IFN-?, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-a	baseline - 3 months - 9 months
Secondary	Letter-Number Sequencing subtest (LNS)	good predictor of fluid intelligence and strongly correlates with laboratory working memory measures.	baseline - 9 months