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

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Schizophrenia

Treatments: Other: TAU (Treatment as usual); Behavioral: Fatigue Management Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04332601

7778

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

ENERGY intervention

Experimental group

Description:

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

Treatment:

Behavioral: Fatigue Management Therapy

Treatment as usual (TAU)

Other group

Description:

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

Treatment:

Other: TAU (Treatment as usual)