Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303596
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-01
Brief Title:
Hippotherapy in Patients With Schizophrenia
Sponsor:
Erzurum Technical University
Organization:
Erzurum Technical University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 260 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
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 260 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None