Clinical trial NCT04476836: Animal-Assisted Therapy in Patients With Schizophrenia
Official title: Animal-Assisted Therapy in Middle-aged and Older Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Animal-assisted Therapy
Keywords: schizophrenia
animal-assisted therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change scores of Positive and Negative Syndrome Scale
timeFrame: Baseline, immediate after treatment
Secondary outcomes:
measure: Change scores of The Assessment of Communication and Interaction Skills
timeFrame: Baseline, immediate after treatment
measure: Change scores of The Taiwanese version of Montreal Cognitive Assessment
timeFrame: Baseline, immediate after treatment
measure: Change scores of Chinese Happiness Inventory
timeFrame: Baseline, immediate after treatment
measure: Change scores of Depression Anxiety Stress Scales-21
timeFrame: Baseline, immediate after treatment
measure: Change scores of Chair Stand Test
timeFrame: Baseline, immediate after treatment
measure: Change scores of Timed Up and Go
timeFrame: Baseline, immediate after treatment
measure: Change scores of The 5-Meter Walk Test
timeFrame: Baseline, immediate after treatment
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung Medical Center
Study officials:
References: