Animal-Assisted Therapy in Patients With Schizophrenia

July 17, 2020 updated by: Chang Gung Memorial Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chyi-Rong Chen, Master
  • Phone Number: 8755 +886-7-7317123
  • Email: ccr776@cgmh.org.tw

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change scores of Positive and Negative Syndrome Scale
Time Frame: Baseline, immediate after treatment
This test is used for measuring symptom severity of patients with schizophrenia.
Baseline, immediate after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change scores of The Assessment of Communication and Interaction Skills
Time Frame: Baseline, immediate after treatment
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
Time Frame: Baseline, immediate after treatment
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
Time Frame: Baseline, immediate after treatment
This test is a subjective measure of well-being.
Baseline, immediate after treatment
Change scores of Depression Anxiety Stress Scales-21
Time Frame: Baseline, immediate after treatment
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
Time Frame: Baseline, immediate after treatment
This test is to measure leg strength.
Baseline, immediate after treatment
Change scores of Timed Up and Go
Time Frame: Baseline, immediate after treatment
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
Time Frame: Baseline, immediate after treatment
This test is to assess walking speed.
Baseline, immediate after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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