SchizophreniaNCT04476836
Animal-Assisted Therapy in Patients With Schizophrenia
A study testing Animal-Assisted Therapy in people with Schizophrenia and Animal-assisted Therapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Schizophrenia, Animal-assisted Therapy
- What is being tested?
- Animal-Assisted Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital, Kaohsiung Medical Center
Kaohsiung City, 833
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Animal-assisted Therapy
- Being tested
- Animal-Assisted Therapy
- Keywords
- schizophrenia, animal-assisted therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-Assisted TherapyOther
Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.
| Study group | Role | What they receive |
|---|---|---|
| AAT group | Experimental | Animal-assisted therapy will be provided one 1-hour session per week for 48 weeks. Receives: Other: Animal-Assisted Therapy |
| control group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Positive and Negative Syndrome Scale
This test is used for measuring symptom severity of patients with schizophrenia.
Measured: Baseline, immediate after treatment
Secondary outcomes (7)
Change scores of The Assessment of Communication and Interaction Skills
This test is an observational rating scale designed to measure communication and interaction skills.
Measured: 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.
Measured: Baseline, immediate after treatment
Change scores of Chinese Happiness Inventory
This test is a subjective measure of well-being.
Measured: 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.
Measured: Baseline, immediate after treatment
Change scores of Chair Stand Test
This test is to measure leg strength.
Measured: 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.
Measured: Baseline, immediate after treatment
Change scores of The 5-Meter Walk Test
This test is to assess walking speed.
Measured: Baseline, immediate after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion24 Aug 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476836
- Sponsor's protocol ID
- 202000549B0
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal-Assisted Therapy in Middle-aged and Older Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT04476836
- Acronym / sponsor ID
- 202000549B0
- Conditions
- Schizophrenia, Animal-assisted Therapy
- Keywords
- schizophrenia, animal-assisted therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 24 Aug 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAT group | Experimental | Other: Animal-Assisted TherapyAnimal-assisted therapy will be provided one 1-hour session per week for 48 weeks. |
| control group | No intervention | –routine care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-Assisted TherapyAnimal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social. | Other | AAT group |
Primary outcome
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.
7 secondary outcomes
Change scores of The Assessment of Communication and Interaction Skills
Time frame: Baseline, immediate after treatment
Change scores of The Taiwanese version of Montreal Cognitive Assessment
Time frame: Baseline, immediate after treatment
Change scores of Chinese Happiness Inventory
Time frame: Baseline, immediate after treatment
Change scores of Depression Anxiety Stress Scales-21
Time frame: Baseline, immediate after treatment
Change scores of Chair Stand Test
Time frame: Baseline, immediate after treatment
Change scores of Timed Up and Go
Time frame: Baseline, immediate after treatment
Change scores of The 5-Meter Walk Test
Time frame: Baseline, immediate after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-Assisted Therapy in people with Schizophrenia and Animal-assisted Therapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chyi-Rong Chen, Master (+886-7-7317123 ext. 8755, ccr776@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Positive and Negative Syndrome Scale (time frame: Baseline, immediate after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.