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Effect of an adapted physical activity program on stress, anxiety, depression in patients with schizophrenia: study protocol of a randomized-controlled trial

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Abstract

Physical activity (PA) is recommended to optimize well-functioning in people with schizophrenia. PA has been found to improve quality of life, general symptomatology, depression, anxiety and stress symptoms, global and social functioning. In PA research, most of the interventions are based on one-on-one interventions but there is poor information about group-based PA interventions. Using a randomized controlled, clinician-blinded trial, subjects are randomized into two arms: the PA group or control group. Our first objective is about to evaluate the effects of a multimodal 6 week collective PA intervention on depression, anxiety, and stress symptoms in people with schizophrenia. Our second objective is about to evaluate these effects on secondary outcomes especially smoking, well-being, physical fitness and on care utilization. All participants are evaluated before and after the 6 week intervention period, and only participants in the PA group are called in a follow-up interview 3 and 6 months after the intervention.

Trial registration Individual Protection Committee of Ile-de-France II, n ID RCB: 2018- A00583-52. Registered on 8 April 2018.

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Availability of data and materials

The data concerning the study are kept at the Cognitive remediation and rehabilitation unit (C3RP), Hôpital Sainte Anne, 1 rue Cabanis, 75014 Paris. As for the clinical data, they are kept in the different places where the patients are treated (University Hospital Service of Mental Health and Therapeutics; Institut Paris Brune). The investigator guarantees access to the source data for the monitor, auditor, or inspector of the competent administrative authority. The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request and data analysis code will be publicly available on Open Science.

Abbreviations

BMI:

Body Mass Index

DASS:

Depression, anxiety, and stress scale

DSM-5:

Diagnostic and Statistical Manual of Mental Disorders

GHU:

« Groupe Hospitalo – Universitaire» (University Hospital Group)

PA:

Physical activity

WHO:

World Health Organization

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Acknowledgment

We would like to thank the patients who participated in the study, as well as the adapted physical activity professionals recruited for the intervention. The authors would like to gratefully acknowledge the Foundation of France, the Clinical Research and Innovation Department of Public Hospital of Paris and the Sainte-Anne Hospital Center of the University Hospital Group of Paris for the funding of the trial.

Funding

Part of the budget of the study is covered by the Foundation of France, and technical support has been given by the GHU Psychiatry & Neurosciences of Paris. This funding covers sports facilities, equipment, personnel costs, purchase of consumables, promotion of the study and other related costs (training, travel, congress missions).

Author information

Authors and Affiliations

  1. University of Montreal, Montreal, QC, Canada

    Lucie Venet-Kelma & Ahmed Jérôme Romain

  2. Research Center of the University Institute of Mental Health of Montreal, Montreal, Canada

    Lucie Venet-Kelma & Ahmed Jérôme Romain

  3. University of Paris Nanterre, Nanterre, France

    Yannick Morvan & Laurence Kern

  4. Paris University Hospital Group Psychiatry & Neurosciences, Paris, France

    Mauricette Mendy, Marjorie Meslier, Isabelle Thoisy, Ghita Dadi, Mona Moualla, Isabelle Amado & Laurence Kern

  5. Resource Center for Cognitive Remediation and Psychosocial Rehabilitation (C3RP), Paris, France

    Mauricette Mendy, Marjorie Meslier, Ghita Dadi, Mona Moualla & Isabelle Amado

  6. Korian Val du Fenouillet Psychiatric Clinic, La Crau, France

    Emmanuel Mulin

  7. Reference Center for Therapeutic Education and Cognitive Remediation, University Hospital of Nantes, Nantes, France

    Marion Chirio-Espitalier

Authors
  1. Lucie Venet-Kelma
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Contributions

IA and LK are the principal investigators and are responsible for the smooth running of the study, devising the study design, obtaining funding and ethics committee approval. IA was involved in recruitment and psychological screening. LK constructed and developed the PA program, trained the professionals in the management of the patients, and supervised the physical assessments and the conduct of the statistical analyses. LV-K managed all patients at the Paris site during the PA program, conducted the physical assessments, assisted with data collection, participated in the statistical analyses and was the principal editor of the present manuscript. IT was the nurse in charge of accompanying the patients during the PA sessions at the Paris site. YM programmed the e-CRF. YM and MM were the principal statisticians in charge of data management and the statistical analyses. GD and MM oversaw patient’s recruitment. MM participated in the neuropsychological assessments prior to the study and participated in the physical assessments and data collection. All authors read and approved the final manuscript. A-JR contributed to a large part of the drafting of the present manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Lucie Venet-Kelma.

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The authors declare that they have no conflict of interests.

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An interview prior to the start of the evaluation is conducted to inform the patients of the conditions of the study, obtain his or her written consent, collect sociodemographic data, as well as prior vital signs.

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Venet-Kelma, L., Morvan, Y., Romain, A.J. et al. Effect of an adapted physical activity program on stress, anxiety, depression in patients with schizophrenia: study protocol of a randomized-controlled trial. Eur Arch Psychiatry Clin Neurosci (2023). https://doi.org/10.1007/s00406-023-01689-5

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