Anorexia NervosaNCT06393491
Equine-assisted Therapy and Anorexia Nervosa
An observational study of Anorexia Nervosa and Equine-Assisted Therapy, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
Background: Severe anorexia nervosa is a complex psychiatric pathology with limited therapeutic tools to reduce morbidity and mortality. Equine-assisted therapy could provide additional therapeutic benefits. Read more about this study
- Who is it for?
- Ages 13 to 25 years, women only
- Conditions the study is for
- Anorexia Nervosa, Equine-Assisted Therapy
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2020to 30 May 2022
- Phase
- Observational
- 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 13 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Female participants who were between 13 and 25 years old and had completed at least 2 sessions of equine-assisted therapy during a hospitalization for anorexia nervosa between 2016 and 2022 in the psychiatric hospitalisation unit of the Institut Mutualiste Montsouris (Paris)
Who may be able to join
- having participated in at least 2 equine-assisted therapy sessions
- being or having been hospitalised between 2016 and 2022 in the psychiatric hospitalisation unit of the Institut Mutualiste Montsouris (Paris)
- ICD 10 diagnosis F50.0/ F.50.1
- female gender
- age between 13 and 25
- fluent French
- consent (including parents if minor participant)
Who cannot join
- having been under the care of C. Lepy (resident) during hospitalisation at the Institut Mutualiste Montsouris (Paris)
- refusal to participate on the part of the participant or the holder of parental authority.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Equine-assisted Therapy in the Management of Adolescent Patients With Severe Anorexia Nervosa: a Qualitative Study
Background: Severe anorexia nervosa is a complex psychiatric pathology with limited therapeutic tools to reduce morbidity and mortality. Equine-assisted therapy could provide additional therapeutic benefits.
Objectives : The investigators aimed to explore the effects of equine assisted therapy on the experience of adolescents with severe anorexia nervosa.
Méthods : Using a qualitative approach based on Interpretative Phenomenological Analysis, the investigators conducted semi-structured interviews with nine participants who had taken part in equine-assisted therapy sessions.
- Conditions
- Anorexia Nervosa, Equine-Assisted Therapy
- Keywords
- Anorexia Nervosa, Equine-Assisted therapy, Animal-assisted therapy, Complementary therapy, Health Care
- Medical subject headings
- Anorexia Nervosa
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured face-to-face interviews of patients was carried out using the Interpretative Phenomenological Analysis (IPA) method.
Interpretative Phenomenological Analysis (IPA) method : this method explores people's perception of experience and how they make sense of it.
IPA is based on three epistemological foundations: phenomenology, hermeneutics and ideography. The phenomenological approach seeks to explore the participant's understanding of the world. Hermeneutics assumes the interpretive dimensions of the results, both in the participant's access to their own experience, and in the researcher's access to the participant's perception of the world.
Measured: Between November 2020 and May 2022, when participants had completed at least 2 sessions of equine-assisted therapy during a hospitalization for anorexia nervosa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start2 Nov 2020
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie LETRANCHANT, MD, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393491
- Sponsor's protocol ID
- EQUINE-ASSISTED THERAPY
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equine-assisted Therapy in the Management of Adolescent Patients With Severe Anorexia Nervosa: a Qualitative Study
- ClinicalTrials.gov ID
- NCT06393491
- Acronym / sponsor ID
- EQUINE-ASSISTED THERAPY
- Conditions
- Anorexia Nervosa, Equine-Assisted Therapy
- Keywords
- Anorexia Nervosa, Equine-Assisted therapy, Animal-assisted therapy, Complementary therapy, Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 1 May 2024 (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.
Background: Severe anorexia nervosa is a complex psychiatric pathology with limited therapeutic tools to reduce morbidity and mortality. Equine-assisted therapy could provide additional therapeutic benefits.
Objectives : The investigators aimed to explore the effects of equine assisted therapy on the experience of adolescents with severe anorexia nervosa.
Méthods : Using a qualitative approach based on Interpretative Phenomenological Analysis, the investigators conducted semi-structured interviews with nine participants who had taken part in equine-assisted therapy sessions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female participants who were between 13 and 25 years old and had completed at least 2 sessions of equine-assisted therapy during a hospitalization for anorexia nervosa between 2016 and 2022 in the psychiatric hospitalisation unit of the Institut Mutualiste Montsouris (Paris)
Key inclusion criteria (7 listed)
- having participated in at least 2 equine-assisted therapy sessions
- being or having been hospitalised between 2016 and 2022 in the psychiatric hospitalisation unit of the Institut Mutualiste Montsouris (Paris)
- ICD 10 diagnosis F50.0/ F.50.1
- female gender
- age between 13 and 25
Key exclusion criteria (2 listed)
- having been under the care of C. Lepy (resident) during hospitalisation at the Institut Mutualiste Montsouris (Paris)
- refusal to participate on the part of the participant or the holder of parental authority.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Semi-structured face-to-face interviews of patients was carried out using the Interpretative Phenomenological Analysis (IPA) method.
Time frame: Between November 2020 and May 2022, when participants had completed at least 2 sessions of equine-assisted therapy during a hospitalization for anorexia nervosa
Interpretative Phenomenological Analysis (IPA) method : this method explores people's perception of experience and how they make sense of it. IPA is based on three epistemological foundations: phenomenology, hermeneutics and ideography. The phenomenological approach seeks to explore the participant's understanding of the world. Hermeneutics assumes the interpretive dimensions of the results, both in the participant's access to their own experience, and in the researcher's access to the participant's perception of the world.
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 1 May 2024.
- Individual participant dataSharing planned: No
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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.
Aurélie LETRANCHANT, MD principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Equine-Assisted Therapy, run by Institut Mutualiste Montsouris 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 7 inclusion and 2 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 1 May 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?
Semi-structured face-to-face interviews of patients was carried out using the Interpretative Phenomenological Analysis (IPA) method. (time frame: Between November 2020 and May 2022, when participants had completed at least 2 sessions of equine-assisted therapy during a hospitalization for anorexia nervosa). 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 1 May 2024.