Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders
PEGASE
Evaluation of the Efficacy of an Equine-assisted Intervention on the Psychosocial Adjustment of Adult Patients Hospitalized and Monitored in Psychiatry: a Randomized Controlled Trial.
1 other identifier
interventional
98
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy of a brief equine-assisted intervention on the social adjustment, assertiveness, self-esteem and coping strategies in adult patients with psychosocial dysfunction, hospitalized and followed in psychiatry, as compared to standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2023
CompletedFebruary 7, 2024
February 1, 2024
2.1 years
April 14, 2021
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Social adjustment (self reported)
Change in the score of the SAS-SR (social adjustment scale -self report) (from 1 (excellent adjustment) to 5 (bad adjustment))
Baseline and 6 months
Social adjustment
Change in the score of the SAS (social adjustment scale) (from 1 (excellent adjustment) to 5 (bad adjustment))
Baseline and 6 months
Secondary Outcomes (3)
Assertiveness
Baseline, 2 and 6 months
Self-esteem
Baseline, 2 and 6 months
Ways of coping
Baseline, 2 and 6 months
Study Arms (2)
Equine-assisted intervention
EXPERIMENTALBrief program (3 sessions)
Control
NO INTERVENTIONStandard care with treatments as usual
Interventions
Usual care including an equine-assisted intervention carried out on foot, next to the horse, in 3 sessions of 3 hours each, spread over 4 weeks. This program is based on self-awareness, communication, assertiveness and adaptability.
Eligibility Criteria
You may not qualify if:
- acute psychiatric crisis
- severe comorbidities (such as mental retardation, mental deterioration) which could invalidate informed consent or limit patient compliance with the study protocol.
- medical contraindication to equine-assisted therapy (allergy, immunocompromised patients)
- pregnancy
- no affiliation to a social security scheme
- deprivation of liberty by a judicial decision
- wardship
- horse phobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Victor Jousselin
Dreux, 28100, France
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-Charles PARIS
Pôle Santé Mentale - Centre Hospitalier de Dreux
- STUDY DIRECTOR
Anne HERON
Unité de Recherche Clinique ARC en CIEL - Centre Hospitalier de Dreux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2021
First Posted
April 20, 2021
Study Start
January 15, 2021
Primary Completion
March 9, 2023
Study Completion
March 9, 2023
Last Updated
February 7, 2024
Record last verified: 2024-02