Equine-assisted TherapyPEGASENCT04850066
Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders
A study testing Equine-assisted intervention in people with Equine-assisted Therapy, run by Centre Hospitalier de Dreux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Equine-assisted Therapy
- What is being tested?
- Equine-assisted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2021to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Equine-assisted Therapy
- Being tested
- Equine-assisted intervention
- Keywords
- Psychiatry, Psychosocial adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine-assisted interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Equine-assisted intervention | Experimental | Brief program (3 sessions) Receives: Behavioral: Equine-assisted intervention |
| Control | No intervention | Standard care with treatments as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: Baseline and 6 months
Social adjustment
Change in the score of the SAS (social adjustment scale) (from 1 (excellent adjustment) to 5 (bad adjustment))
Measured: Baseline and 6 months
Secondary outcomes (3)
Assertiveness
Change in the score of the Rathus assertiveness schedule (from -90 (difficulties of assertivity) to +90 (good assertivity))
Measured: Baseline, 2 and 6 months
Self-esteem
Change in the score of the Rosenberg's Self-Esteem scale (from 10 to 40).
Measured: Baseline, 2 and 6 months
Ways of coping
Change in the score of the Ways of coping checklist (from 27 to 108).
Measured: Baseline, 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start15 Jan 2021
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equine-assisted TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Dreux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Charles PARIS, Principal investigator, Pôle Santé Mentale - Centre Hospitalier de DreuxAnne HERON, Study director, Unité de Recherche Clinique ARC en CIEL - Centre Hospitalier de Dreux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850066
- Sponsor's protocol ID
- 2018-A00022-53
- Acronym
- PEGASE
- Status last verified
- Feb 2024
- First submitted
- 14 Apr 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04850066
- Acronym / sponsor ID
- PEGASE / 2018-A00022-53
- Conditions
- Equine-assisted Therapy
- Keywords
- Psychiatry, Psychosocial adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier de DreuxUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Equine-assisted intervention | Experimental | Behavioral: Equine-assisted interventionBrief program (3 sessions) |
| Control | No intervention | –Standard care with treatments as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equine-assisted interventionUsual 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. | Behavioural | Equine-assisted intervention |
Primary outcome
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))
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))
3 secondary outcomes
Assertiveness
Time frame: Baseline, 2 and 6 months
Self-esteem
Time frame: Baseline, 2 and 6 months
Ways of coping
Time frame: Baseline, 2 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Related trials for Equine-assisted Therapy
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Not yet recruiting
The Impact of Equine-Assisted Therapy on Mental Health and Addictive Behaviors in Patients Receiving Addiction Treatment
Equine-assisted Therapy, Addiction
Recruiting
Does Hippotherapy Have an Effect on Mobility, Gait, Balance and Perceived Health-related Quality of Life in Persons With Parkinson's Disease?
Parkinson Disease
Not yet recruiting
Neuroproprioceptive Equine-Assisted Physiotherapy for Spinal Muscular Atrophy
Spinal Muscular Atrophy (SMA)
Not yet recruiting
Examining the Feasibility of an Outdoor Therapeutic Horse Carriage As a Perturbation -based Balance Training
Balance Impairment, Accidental Fall
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Charles PARIS principal investigator
Pôle Santé Mentale - Centre Hospitalier de Dreux
Anne HERON study director
Unité de Recherche Clinique ARC en CIEL - Centre Hospitalier de Dreux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equine-assisted intervention in people with Equine-assisted Therapy, run by Centre Hospitalier de Dreux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social adjustment (self reported) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.