NCT04476836

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

23 days

First QC Date

July 16, 2020

Last Update Submit

July 17, 2020

Conditions

Keywords

schizophreniaanimal-assisted therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change scores of The Assessment of Communication and Interaction Skills

    Baseline, immediate after treatment

  • Change scores of The Taiwanese version of Montreal Cognitive Assessment

    Baseline, immediate after treatment

  • Change scores of Chinese Happiness Inventory

    Baseline, immediate after treatment

  • Change scores of Depression Anxiety Stress Scales-21

    Baseline, immediate after treatment

  • Change scores of Chair Stand Test

    Baseline, immediate after treatment

  • +2 more secondary outcomes

Study Arms (2)

AAT group

EXPERIMENTAL

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

Other: Animal-Assisted Therapy

control group

NO INTERVENTION

routine care

Interventions

Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.

AAT group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Kaohsiung Medical Center

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Chyi-Rong Chen, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 20, 2020

Study Start

August 1, 2020

Primary Completion

August 24, 2020

Study Completion

December 1, 2020

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations