Hippotherapy in Patients With Schizophrenia

NCT ID: NCT06303596

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2024-10-01

Brief Summary

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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

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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

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Equine-Assisted Therapy Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The evaluator who collects the data is blinded to the allocation of groups.

Study Groups

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Experimental: Experimental group

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.

Group Type EXPERIMENTAL

Hippotherapy

Intervention Type OTHER

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 treatment

Intervention Type OTHER

Standard psychiatric treatment: Standard psychiatric treatment includes medication and routine activities provided by the Community Mental Health Center.

Other: Control group

The control group would receive only standard psychiatric treatment.

Group Type OTHER

Standard psychiatric treatment

Intervention Type OTHER

Standard psychiatric treatment: Standard psychiatric treatment includes medication and routine activities provided by the Community Mental Health Center.

Interventions

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Hippotherapy

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.

Intervention Type OTHER

Standard psychiatric treatment

Standard psychiatric treatment: Standard psychiatric treatment includes medication and routine activities provided by the Community Mental Health Center.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erzurum Technical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeynep Oztürk, Ph.D., Assist. Prof.

Role: STUDY_DIRECTOR

Erzurum Technical University

Nurgül Karakurt, Ph.D., Assist. Prof.

Role: PRINCIPAL_INVESTIGATOR

Erzurum Technical University

Elif O Tozoğlu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Erzurum Community Mental Health Center

Musa Eymir, Ph.D., PT, Assist. Prof.

Role: PRINCIPAL_INVESTIGATOR

Erzurum Technical University

Serdar Ulusoy

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Erzurum Technical University, Erzurum Community Mental Health Center

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Musa Eymir, Ph.D., PT, Assist. Prof.

Role: CONTACT

+904424445388-2733

Facility Contacts

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Musa Eymir, Ph.D., PT, Assist. Prof.

Role: primary

+904424445388-2733

Other Identifiers

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Hippotherapy in Schizophrenia

Identifier Type: -

Identifier Source: org_study_id

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