Hippotherapy in Patients With Schizophrenia

NCT06303596 | Not Yet Recruiting

• 1 other identifier: Hippotherapy in Schizophrenia
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Equine-Assisted Therapy; Schizophrenia

Keywords

hippotherapy; schizophrenia; quality of life; anxiety; loneliness

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  For two study groups: at pre-intervention and immediately after the intervention.

Study Arms (2)

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.

Other: Hippotherapy; Other: Standard psychiatric treatment

Other: Control group

OTHER

The control group would receive only standard psychiatric treatment.

Other: Standard psychiatric treatment

Interventions

Hippotherapy 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.

Experimental: Experimental group

Standard psychiatric treatment OTHER

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

Experimental: Experimental group; Other: Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzurum Technical University: lead

Study Sites (1)

Erzurum Technical University, Erzurum Community Mental Health Center

Erzurum, 25010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia; Anxiety Disorders

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Zeynep Oztürk, Ph.D., Assist. Prof.

  Erzurum Technical University

  STUDY DIRECTOR

• Nurgül Karakurt, Ph.D., Assist. Prof.

  Erzurum Technical University

  PRINCIPAL INVESTIGATOR

• Elif O Tozoğlu, M.D.

  Erzurum Community Mental Health Center

  PRINCIPAL INVESTIGATOR

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

  Erzurum Technical University

  PRINCIPAL INVESTIGATOR

• Serdar Ulusoy

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+904424445388-2733; musa.eymir@erzurum.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator who collects the data is blinded to the allocation of groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 12, 2024
• Study Start: March 20, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TU (1)