跳至主要内容
临床试验/NCT06303596
NCT06303596尚未招募不适用

Investigating the Efficacy of Hippotherapy Program on Disease Symptoms, Quality of Life, Anxiety and Loneliness Levels in Patients With Schizophrenia: A Randomized Controlled Trial

Erzurum Technical University2 个研究点 分布在 2 个国家目标入组 88 人开始时间: 2024年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
88
试验地点
2
主要终点
State-Trait Anxiety Inventory (STAI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Hippotherapy (Other)

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.

干预措施: Standard psychiatric treatment (Other)

Other: Control group

Other

The control group would receive only standard psychiatric treatment.

干预措施: Standard psychiatric treatment (Other)

结局指标

主要结局

State-Trait Anxiety Inventory (STAI)

时间窗: 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.

UCLA Loneliness Scale

时间窗: 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.

The Positive and Negative Syndrome Scale (PANSS)

时间窗: 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.

The Quality of Life Scale (QLS)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验