Equine-Assisted TherapyNCT06303596
Hippotherapy in Patients With Schizophrenia
A study testing Hippotherapy and Standard psychiatric treatment in people with Equine-Assisted Therapy and Schizophrenia, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Equine-Assisted Therapy, Schizophrenia
- What is being tested?
- Hippotherapy and Standard psychiatric treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 1 Oct 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with schizophrenia,
- Being at an age of older than 18 years,
- Being registered with and treated at the Community Mental Health Center,
- Being at remission period (a stable condition) at the time of enrollment and throughout the study.
- Being able to provide written informed consent and comprehend the instruments.
Who cannot join
- The participants who suffer from other comorbid psychiatric disorders (depression, personality disorder, substance addiction, etc.),
- The participants who are not willing to sign the consent.
- The participants who have physical health problems that would prevent horseback-riding.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Technical University, Erzurum Community Mental Health Center
Erzurum, 25010
Musa Eymir, Ph.D., PT, Assist. Prof., +904424445388-2733, musa.eymir@erzurum.edu.tr
About this study
Official title: Investigating the Efficacy of Hippotherapy Program on Disease Symptoms, Quality of Life, Anxiety and Loneliness Levels in Patients With Schizophrenia: A Randomized Controlled Trial
This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention.
Read the detailed description
Background: Schizophrenia is a multifactorial disorder characterized by cognitive and affective symptoms such as distortions of thinking and perception and loss of normal affective expressiveness. Since schizophrenia is a complex disorder, the management of the disease should include a combination of medication, psychotherapy and other supportive psychosocial interventions. One of the commonly used psychosocial interventions is hippotherapy which is incorporated into comprehensive rehabilitation therapy sessions aimed at restoring lost function, alleviate, minimize or eliminate physical, psychological, social or mental disability of the patients with various disorders.
Aim: The investigators hypothesize that hippotherapy, as an adjuvant to standard psychiatric treatment, could have significant effect on disease symptoms, quality of life, anxiety and loneliness levels of patients with schizophrenia. Therefore, in this study, the investigators will determine the effect of hippotherapy on disease symptoms, quality of life, anxiety and loneliness levels in patients with schizophrenia.
Methods: The study is designed as a single-blinded, randomized controlled trial. The sample of this study will be selected from patients who are eligible for the study and registered at the Community Mental Health Center. These centers aiming to increase the functional and mental recovery of patients with schizophrenia are composed of a team where different professionals as psychiatrists, psychologists, social workers, and nurses are present. In these centers, there are activities aimed at providing skills in business and social areas, training groups for disease, and giving information on medication and disease management. Participants are randomly allocated into two groups using blocked randomization. All participants received the standard psychiatric treatment, while the experimental groups are additionally provided with a 16-session hippotherapy program for 8 weeks.
Participants and demographic data: Participants who have been diagnosed with schizophrenia take part in the study after informed consent is obtained. The participants are able to express themselves and to individually complete the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale.
Measures: The demographic characteristics, including variables such as sex, age, duration of disease, years of education, marital status, work status, and medications, will be recorded. In addition, four scales will be administered to patients for evaluating disease symptoms, quality of life, anxiety and loneliness levels.
Procedure and Data collection: Ethical approval is obtained from the Local Medical Ethics Committee. Following informed consent, each participant will fill out a demographic questionnaire and complete the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at baseline and after the intervention. A well-trained and licensed psychiatric nurse will perform the data collection and assists the participants if there were difficulties reading or understanding the questionnaires.
Statistical analysis: This study will employ Statistical Package for Social Sciences (SPSS) Version 26.0 to analyze the collected data. The data analyses will include demographic variables and the scores of the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale.
- Conditions
- Equine-Assisted Therapy, Schizophrenia
- Being tested
- Hippotherapy, Standard psychiatric treatment
- Keywords
- hippotherapy, schizophrenia, quality of life, anxiety, loneliness
- Medical subject headings
- Schizophrenia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
Hippotherapy: Hippotherapy in psychiatry is not concerned only about the patient sitting on a horse and the horseback movement influencing the physical condition of the patient and his functional and postural disorders. This therapy is concerned with positive effects on a patient's mental state and use mainly contact with the horse, work with the horse from the ground and riding on horseback. It aims for enjoyment, social communication, and the development of cognitive and executive functions.
Standard psychiatric treatmentOther
Standard psychiatric treatment: Standard psychiatric treatment includes medication and routine activities provided by the Community Mental Health Center.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental group | Experimental | The experimental group would receive standard psychiatric treatment.
Additionally, the experimental group would be provided with a 16-session hippotherapy program for 8 weeks, as an adjuvant to standard psychiatric treatment. Receives: Other: Hippotherapy; Other: Standard psychiatric treatment |
| Other: Control group | Other | The control group would receive only standard psychiatric treatment. Receives: Other: Standard psychiatric treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive and Negative Syndrome Scale (PANSS)
The Positive and Negative Syndrome Scale is used for measuring symptom severity of schizophrenia. The PANSS is a 30-item clinician-administered rating scale. It quantifies positive symptoms, which refer to an excess or distortion of normal functions (e.g., hallucinations and delusions), and negative symptoms, which represent a diminution or loss of normal functions.
Measured: For two study groups: at pre-intervention and immediately after the intervention.
State-Trait Anxiety Inventory (STAI)
The STAI is a self-report scale that assesses separate dimensions of "state" and "trait" anxiety. Examples of what the STAI measures include feelings of apprehension, tension, nervousness, and worry.
Measured: For two study groups: at pre-intervention and immediately after the intervention.
The Quality of Life Scale (QLS)
The Quality of Life Scale (QLS) is a 21-item scale rated from a semi-structured interview providing information on symptoms and functioning. It is divided into four dimensions: Intrapsychic Foundations, Interpersonal Relations, Instrumental Role Functioning, and Common Objects and Activities. The total score of the scale and each of the domains ranges from 0 to 6.
Measured: For two study groups: at pre-intervention and immediately after the intervention.
UCLA Loneliness Scale
UCLA Loneliness Scale is a 20-item scale which designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
Measured: For two study groups: at pre-intervention and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Mar 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeynep Oztürk, Ph.D., Assist. Prof., Study director, Erzurum Technical UniversityNurgül Karakurt, Ph.D., Assist. Prof., Principal investigator, Erzurum Technical UniversityElif O Tozoğlu, M.D., Principal investigator, Erzurum Community Mental Health CenterMusa Eymir, Ph.D., PT, Assist. Prof., Principal investigator, Erzurum Technical UniversitySerdar Ulusoy, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303596
- Sponsor's protocol ID
- Hippotherapy in Schizophrenia
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Hippotherapy Program on Disease Symptoms, Quality of Life, Anxiety and Loneliness Levels in Patients With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06303596
- Acronym / sponsor ID
- Hippotherapy in Schizophrenia
- Conditions
- Equine-Assisted Therapy, Schizophrenia
- Keywords
- hippotherapy, schizophrenia, quality of life, anxiety, loneliness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 12 Mar 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.
This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention.
Detailed description
Background: Schizophrenia is a multifactorial disorder characterized by cognitive and affective symptoms such as distortions of thinking and perception and loss of normal affective expressiveness. Since schizophrenia is a complex disorder, the management of the disease should include a combination of medication, psychotherapy and other supportive psychosocial interventions. One of the commonly used psychosocial interventions is hippotherapy which is incorporated into comprehensive rehabilitation therapy sessions aimed at restoring lost function, alleviate, minimize or eliminate physical, psychological, social or mental disability of the patients with various disorders.
Aim: The investigators hypothesize that hippotherapy, as an adjuvant to standard psychiatric treatment, could have significant effect on disease symptoms, quality of life, anxiety and loneliness levels of patients with schizophrenia. Therefore, in this study, the investigators will determine the effect of hippotherapy on disease symptoms, quality of life, anxiety and loneliness levels in patients with schizophrenia.
Methods: The study is designed as a single-blinded, randomized controlled trial. The sample of this study will be selected from patients who are eligible for the study and registered at the Community Mental Health Center. These centers aiming to increase the functional and mental recovery of patients with schizophrenia are composed of a team where different professionals as psychiatrists, psychologists, social workers, and nurses are present. In these centers, there are activities aimed at providing skills in business and social areas, training groups for disease, and giving information on medication and disease management. Participants are randomly allocated into two groups using blocked randomization. All participants received the standard psychiatric treatment, while the experimental groups are additionally provided with a 16-session hippotherapy program for 8 weeks.
Participants and demographic data: Participants who have been diagnosed with schizophrenia take part in the study after informed consent is obtained. The participants are able to express themselves and to individually complete the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale.
Measures: The demographic characteristics, including variables such as sex, age, duration of disease, years of education, marital status, work status, and medications, will be recorded. In addition, four scales will be administered to patients for evaluating disease symptoms, quality of life, anxiety and loneliness levels.
Procedure and Data collection: Ethical approval is obtained from the Local Medical Ethics Committee. Following informed consent, each participant will fill out a demographic questionnaire and complete the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at baseline and after the intervention. A well-trained and licensed psychiatric nurse will perform the data collection and assists the participants if there were difficulties reading or understanding the questionnaires.
Statistical analysis: This study will employ Statistical Package for Social Sciences (SPSS) Version 26.0 to analyze the collected data. The data analyses will include demographic variables and the scores of the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental group | Experimental | Other: Hippotherapy, Other: Standard psychiatric treatmentThe experimental group would receive standard psychiatric treatment. Additionally, the experimental group would be provided with a 16-session hippotherapy program for 8 weeks, as an adjuvant to standard psychiatric treatment. |
| Other: Control group | Other | Other: Standard psychiatric treatmentThe control group would receive only standard psychiatric treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with schizophrenia,
- Being at an age of older than 18 years,
- Being registered with and treated at the Community Mental Health Center,
- Being at remission period (a stable condition) at the time of enrollment and throughout the study.
- Being able to provide written informed consent and comprehend the instruments.
Key exclusion criteria (3 listed)
- The participants who suffer from other comorbid psychiatric disorders (depression, personality disorder, substance addiction, etc.),
- The participants who are not willing to sign the consent.
- The participants who have physical health problems that would prevent horseback-riding.
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 |
|---|---|---|
| HippotherapyHippotherapy: Hippotherapy in psychiatry is not concerned only about the patient sitting on a horse and the horseback movement influencing the physical condition of the patient and his functional and postural disorders. This therapy is concerned with positive effects on a patient's mental state and use mainly contact with the horse, work with the horse from the ground and riding on horseback. It aims for enjoyment, social communication, and the development of cognitive and executive functions. | Other | Experimental: Experimental group |
| Standard psychiatric treatmentStandard psychiatric treatment: Standard psychiatric treatment includes medication and routine activities provided by the Community Mental Health Center. | Other | Experimental: Experimental group, Other: Control group |
Primary outcome
The Positive and Negative Syndrome Scale (PANSS)
Time frame: For two study groups: at pre-intervention and immediately after the intervention.
The Positive and Negative Syndrome Scale is used for measuring symptom severity of schizophrenia. The PANSS is a 30-item clinician-administered rating scale. It quantifies positive symptoms, which refer to an excess or distortion of normal functions (e.g., hallucinations and delusions), and negative symptoms, which represent a diminution or loss of normal functions.
State-Trait Anxiety Inventory (STAI)
Time frame: For two study groups: at pre-intervention and immediately after the intervention.
The STAI is a self-report scale that assesses separate dimensions of "state" and "trait" anxiety. Examples of what the STAI measures include feelings of apprehension, tension, nervousness, and worry.
The Quality of Life Scale (QLS)
Time frame: For two study groups: at pre-intervention and immediately after the intervention.
The Quality of Life Scale (QLS) is a 21-item scale rated from a semi-structured interview providing information on symptoms and functioning. It is divided into four dimensions: Intrapsychic Foundations, Interpersonal Relations, Instrumental Role Functioning, and Common Objects and Activities. The total score of the scale and each of the domains ranges from 0 to 6.
UCLA Loneliness Scale
Time frame: For two study groups: at pre-intervention and immediately after the intervention.
UCLA Loneliness Scale is a 20-item scale which designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Zeynep Oztürk, Ph.D., Assist. Prof. study director
Erzurum Technical University
Nurgül Karakurt, Ph.D., Assist. Prof. principal investigator
Erzurum Technical University
Elif O Tozoğlu, M.D. principal investigator
Erzurum Community Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy and Standard psychiatric treatment in people with Equine-Assisted Therapy and Schizophrenia, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Musa Eymir, Ph.D., PT, Assist. Prof. (+904424445388-2733, musa.eymir@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive and Negative Syndrome Scale (PANSS) (time frame: For two study groups: at pre-intervention and immediately after the intervention.). The study lists 4 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 12 Mar 2024.