Clinical trial NCT02599766: Effects of Animal-assisted Therapy on Brain-injured Patients
Official title: Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Social Functioning
Keywords: animal assisted intervention, brain injury, rehabilitation
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Institute for Interdisciplinary Research on the Human-Pet Relationship
First posted: 2015-11-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial effects on patients with brain injuries. This study investigates the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 25 patients over 24 therapy sessions. While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients who are in a slightly advanced rehabilitation process, assessed via their function profile, are investigated.

Detailed description: This study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable "standard" therapy session without the presence of an animal.

Over a period of six weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 24 therapy sessions (12 experimental, 12 control) for each patient.

Each therapy session lasts 30 minutes with an additional 5 minutes before and 10 minutes after the session for filling in the questionnaires.

The study takes place at REHAB Basel. Animal-assisted therapies will be held at the "Therapie-Tiergarten" at REHAB Basel in the presence of one or more animals that will be selected by the therapist and the patient together and with which the patient has a relationship.

Patients who are willing to join the study will be selected and allocated randomly to start with either the experimental or the control condition.

Participation in the study will be cancelled if a patient wishes to do so or if they choose to withdraw from the animal-assisted therapy program. Other criteria for withdrawal are if the patient is harmed by an animal or if the animals are abused by the patient.

Eligibility criteria: Inclusion Criteria:

* patient at REHAB Basel
* brain-injury
* willing to participate in animal-assisted therapies
* physical and psychological resilience and ability to go/be transported outside to the "Therapie-Tiergarten"
* ability to get in contact with the animal autonomously

Exclusion Criteria:

* medical contraindications:allergies, phobias, etc.
* no willingness to participate in animal-assisted therapies
* patient might present a danger to the animals (aggressive behaviour)
* patient's medication changes radically during the time of data collection

Primary outcomes:
measure: Social Functioning: Total Social Behavior
timeFrame: 6 weeks
Secondary outcomes:
measure: Social Functioning: Verbal Communication
timeFrame: 6 weeks
measure: Social Functioning: Nonverbal Communication
timeFrame: 6 weeks
measure: Social Functioning: Physical Contact
timeFrame: 6 weeks
measure: Social Functioning: Attention
timeFrame: 6 weeks
measure: Positive Emotional Display
timeFrame: 6 weeks
measure: Negative Emotional Display
timeFrame: 6 weeks
measure: Neutral Emotional Display
timeFrame: 6 weeks
measure: Mood 1: Motivation
timeFrame: 6 weeks
measure: Mood 2: Bipolar Mood Dimension (Good-bad)
timeFrame: 6 weeks
measure: Mood 3: Satisfaction Self-assessment
timeFrame: 6 weeks
measure: Mood 4: Satisfaction Therapist Rating
timeFrame: 6 weeks
measure: Heart Rate
timeFrame: 6 weeks
measure: Motor Activity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: REHAB Basel
Study officials:
affiliation: Rehab Basel
name: Margret Hund-Georgiadis, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gocheva V, Hund-Georgiadis M, Hediger K. Effects of animal-assisted therapy on concentration and attention span in patients with acquired brain injury: A randomized controlled trial. Neuropsychology. 2018 Jan;32(1):54-64. doi: 10.1037/neu0000398. Epub 2017 Oct 16.