NCT04332601

Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	Fatigue Management Therapy	14 sessions of 1h CBT intervention
OTHER	TAU (Treatment as usual)	No CBT intervention

Timeline

• Start date: 2022-02-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2020-04-02
• Last updated: 2022-02-11