Animal-Assisted Therapy in Patients With Schizophrenia

Animal-Assisted Therapy in Middle-aged and Older Patients With Schizophrenia

Animal-assisted therapy (AAT) can be helpful to improve the psychiatric, emotional, physical,and social status in patients with physical and mental illness and the elderly.

The study aims to investigate the effects of AAT program in middle-aged and older patients with schizophrenia. The investigators will recruit 40 patients with schizophrenia in psychiatric ward randomised into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions before and after intervention, including PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Animal-assisted Therapy
• Intervention / Treatment: Other: Animal-Assisted Therapy

Detailed Description

Animal-assisted therapy (AAT) can be helpful to improve the outcomes of psychiatric and emotional symptoms, physical activeness, social skills, well-beings in patients with physical and mental illness and the elderly.

The study aims to assess the applications and outcomes of psychiatric symptoms, social skills, cognitive function, well-beings, emotional status and physical fitness of AAT program applied to middle-aged and older patients with chronic schizophrenia.

The investigators will recruit 40 patients with chronic schizophrenia who were admitted to day care ward and rehabilitation ward, and conduct a randomized, controlled study. 40 patients will be stratified by the ward into AAT group and control group. AAT group will complete the 12-week program. This study contains two assessment sessions completed within one week before and after 12-week program. Subjects will be evaluated by the PANSS, ACIS, MoCA-T, CHI, DASS-21, CST, TUG and 5MWT in both sessions. Statistical analysis is examined using paired t-test to see whether there is a significant difference (based on p-value) between the scores of two assessment sessions in the AAT and control group, and using independent t-test to see whether there is a significant difference in the change scores of two assessment sessions between the 2 groups.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Chang Gung Memorial Hospital, Kaohsiung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Having a diagnosis of schizophrenia according to the DSM-5.
2. Adult aged 40 years or older.
3. Having stable physical and psychological health conditions based on master clinician judgment.
4. Having the will to participate in the study after thorough comprehension of the content.
5. Not receiving treatment protocol last half a year.

Exclusion Criteria:

1. Severe cognitive impairment e.g. aphasia, being unable to follow 3 or more orders.
2. Being allergic to animals.
3. History of Asthma.
4. Coagulation disorders
5. presenting symptoms of specific phobia, anxiety disorder and obsessive-compulsive disorder in context of dog, infection and contamination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; routine care
Experimental: AAT group; Animal-assisted therapy will be provided one 1-hour session per week for 48 weeks.	Other: Animal-Assisted Therapy; Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change scores of Positive and Negative Syndrome Scale	This test is used for measuring symptom severity of patients with schizophrenia.	Baseline, immediate after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change scores of The Assessment of Communication and Interaction Skills	This test is an observational rating scale designed to measure communication and interaction skills.	Baseline, immediate after treatment
Change scores of The Taiwanese version of Montreal Cognitive Assessment	This test is a cognitive screening test in the detection of mild cognitive impairment and Alzheimer's disease.	Baseline, immediate after treatment
Change scores of Chinese Happiness Inventory	This test is a subjective measure of well-being.	Baseline, immediate after treatment
Change scores of Depression Anxiety Stress Scales-21	This test is a 21-item self report instrument for measuring depression, anxiety and tension/stress.	Baseline, immediate after treatment
Change scores of Chair Stand Test	This test is to measure leg strength.	Baseline, immediate after treatment
Change scores of Timed Up and Go	This test is to assess mobility, balance, walking ability, and fall risk in older adults.	Baseline, immediate after treatment
Change scores of The 5-Meter Walk Test	This test is to assess walking speed.	Baseline, immediate after treatment

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 24, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: schizophrenia; animal-assisted therapy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 202000549B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No