Assessment of the Efficacy of a Fatigue Management Therapy in Schizophrenia
NCT ID: NCT04332601
Last Updated: 2022-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2022-02-28
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Correlates of Fatigue in People With Schizophrenia
NCT06397950
Study of the Effectiveness of Mental Contrasting and Implementation Intention in the Management of Apathy in Schizophrenia
NCT04781179
Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia
NCT03407950
Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography
NCT00942981
Treatment of Negative Symptoms and Schizophrenia
NCT02204787
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Fatigue Management Therapy
14 sessions of 1h CBT intervention
Treatment as usual (TAU)
* Comparison group
* TAU defined by antipsychotic medication coupled with day hospital care
TAU (Treatment as usual)
No CBT intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fatigue Management Therapy
14 sessions of 1h CBT intervention
TAU (Treatment as usual)
No CBT intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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,
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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Université Montpellier
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
7778
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.