Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders (PEGASE)

February 5, 2024 updated by: Centre Hospitalier de Dreux

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Unité de Recherche Clinique URC28
  • Phone Number: +33237515253
  • Email: urc@ch-dreux.fr

Study Locations

  • France
      • Dreux, France, 28100
        • Centre Hospitalier Victor Jousselin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients hospitalized in psychiatry with mental disorders lasting for more than 6 months with an EGF score on the Global Evaluation of Psychosocial Functioning scale of between 31 and 60 at the time of inclusion.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Equine-assisted intervention
Brief program (3 sessions)
Behavioral: Equine-assisted intervention
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.
No Intervention: Control
Standard care with treatments as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social adjustment (self reported)
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
Change in the score of the SAS (social adjustment scale) (from 1 (excellent adjustment) to 5 (bad adjustment))
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assertiveness
Time Frame: Baseline, 2 and 6 months
Change in the score of the Rathus assertiveness schedule (from -90 (difficulties of assertivity) to +90 (good assertivity))
Baseline, 2 and 6 months
Self-esteem
Time Frame: Baseline, 2 and 6 months
Change in the score of the Rosenberg's Self-Esteem scale (from 10 to 40).
Baseline, 2 and 6 months
Ways of coping
Time Frame: Baseline, 2 and 6 months
Change in the score of the Ways of coping checklist (from 27 to 108).
Baseline, 2 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Dreux

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

March 9, 2023

Study Completion (Actual)

March 9, 2023

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-A00022-53

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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