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Animal-Assisted Therapy in Patients With Schizophrenia

Primary Purpose

Schizophrenia, Animal-assisted Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Animal-Assisted Therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, animal-assisted therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung Memorial Hospital, Kaohsiung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AAT group

control group

Arm Description

Animal-assisted therapy will be provided one 1-hour session per week for 48 weeks.

routine care

Outcomes

Primary Outcome Measures

Change scores of Positive and Negative Syndrome Scale
This test is used for measuring symptom severity of patients with schizophrenia.

Secondary Outcome Measures

Change scores of The Assessment of Communication and Interaction Skills
This test is an observational rating scale designed to measure communication and interaction skills.
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.
Change scores of Chinese Happiness Inventory
This test is a subjective measure of well-being.
Change scores of Depression Anxiety Stress Scales-21
This test is a 21-item self report instrument for measuring depression, anxiety and tension/stress.
Change scores of Chair Stand Test
This test is to measure leg strength.
Change scores of Timed Up and Go
This test is to assess mobility, balance, walking ability, and fall risk in older adults.
Change scores of The 5-Meter Walk Test
This test is to assess walking speed.

Full Information

First Posted
July 16, 2020
Last Updated
July 17, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04476836
Brief Title
Animal-Assisted Therapy in Patients With Schizophrenia
Official Title
Animal-Assisted Therapy in Middle-aged and Older Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
August 24, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Animal-assisted Therapy
Keywords
schizophrenia, animal-assisted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AAT group
Arm Type
Experimental
Arm Description
Animal-assisted therapy will be provided one 1-hour session per week for 48 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Other
Intervention Name(s)
Animal-Assisted Therapy
Intervention Description
Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.
Primary Outcome Measure Information:
Title
Change scores of Positive and Negative Syndrome Scale
Description
This test is used for measuring symptom severity of patients with schizophrenia.
Time Frame
Baseline, immediate after treatment
Secondary Outcome Measure Information:
Title
Change scores of The Assessment of Communication and Interaction Skills
Description
This test is an observational rating scale designed to measure communication and interaction skills.
Time Frame
Baseline, immediate after treatment
Title
Change scores of The Taiwanese version of Montreal Cognitive Assessment
Description
This test is a cognitive screening test in the detection of mild cognitive impairment and Alzheimer's disease.
Time Frame
Baseline, immediate after treatment
Title
Change scores of Chinese Happiness Inventory
Description
This test is a subjective measure of well-being.
Time Frame
Baseline, immediate after treatment
Title
Change scores of Depression Anxiety Stress Scales-21
Description
This test is a 21-item self report instrument for measuring depression, anxiety and tension/stress.
Time Frame
Baseline, immediate after treatment
Title
Change scores of Chair Stand Test
Description
This test is to measure leg strength.
Time Frame
Baseline, immediate after treatment
Title
Change scores of Timed Up and Go
Description
This test is to assess mobility, balance, walking ability, and fall risk in older adults.
Time Frame
Baseline, immediate after treatment
Title
Change scores of The 5-Meter Walk Test
Description
This test is to assess walking speed.
Time Frame
Baseline, immediate after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having a diagnosis of schizophrenia according to the DSM-5. Adult aged 40 years or older. Having stable physical and psychological health conditions based on master clinician judgment. Having the will to participate in the study after thorough comprehension of the content. Not receiving treatment protocol last half a year. Exclusion Criteria: Severe cognitive impairment e.g. aphasia, being unable to follow 3 or more orders. Being allergic to animals. History of Asthma. Coagulation disorders presenting symptoms of specific phobia, anxiety disorder and obsessive-compulsive disorder in context of dog, infection and contamination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chyi-Rong Chen, Master
Phone
+886-7-7317123
Ext
8755
Email
ccr776@cgmh.org.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Kaohsiung Medical Center
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

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Animal-Assisted Therapy in Patients With Schizophrenia

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