Clinical trial NCT06303596: Hippotherapy in Patients With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Equine-Assisted Therapy
Schizophrenia
Keywords: hippotherapy
schizophrenia
quality of life
anxiety
loneliness
Lead sponsor: Erzurum Technical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: For two study groups: at pre-intervention and immediately after the intervention.
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: For two study groups: at pre-intervention and immediately after the intervention.
measure: The Quality of Life Scale (QLS)
timeFrame: For two study groups: at pre-intervention and immediately after the intervention.
measure: UCLA Loneliness Scale
timeFrame: For two study groups: at pre-intervention and immediately after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University, Erzurum Community Mental Health Center
Study officials:
affiliation: Erzurum Technical University
name: Zeynep Oztürk, Ph.D., Assist. Prof.
role: STUDY_DIRECTOR
affiliation: Erzurum Technical University
name: Nurgül Karakurt, Ph.D., Assist. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erzurum Community Mental Health Center
name: Elif O Tozoğlu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erzurum Technical University
name: Musa Eymir, Ph.D., PT, Assist. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: Serdar Ulusoy
role: PRINCIPAL_INVESTIGATOR
References: