Impaired Social FunctioningNCT02599766
Effects of Animal-assisted Therapy on Brain-injured Patients
A study testing animal assisted therapy and standard therapy in people with Impaired Social Functioning, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Social Functioning
- What is being tested?
- animal assisted therapy and standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel
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.
Read the 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.
- Conditions
- Impaired Social Functioning
- Being tested
- animal assisted therapy, standard therapy
- Keywords
- animal assisted intervention, brain injury, rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animal assisted therapyOther
physiotherapy, speech therapy and occupational therapy in the presence of an animal
standard therapyOther
standard physiotherapy, standard speech therapy and standard occupational therapy
| Study group | Role | What they receive |
|---|---|---|
| animal assisted therapy | Experimental | "Standard therapy" that is done in the presence and with integrating an animal. Receives: Other: animal assisted therapy |
| standard therapy | Active comparator | "Standard therapy" without the presence of an animal. Receives: Other: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning: Total Social Behavior
Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of all social behaviors are collected and aggregated to one measure, the total social behavior.
Measured: 6 weeks
Secondary outcomes (13)
Social Functioning: Verbal Communication
Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentages of the defined verbal behaviors is collected and aggregated to one measure.
Measured: 6 weeks
Social Functioning: Nonverbal Communication
Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined nonverbal behaviors is collected and aggregated to one measure.
Measured: 6 weeks
Social Functioning: Physical Contact
Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined physical contact is collected and aggregated to one measure.
Measured: 6 weeks
Social Functioning: Attention
Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined attention behavior is collected and aggregated to one measure.
Measured: 6 weeks
Positive Emotional Display
Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of positive emotion.
Measured: 6 weeks
Negative Emotional Display
Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of negative emotion.
Measured: 6 weeks
Neutral Emotional Display
Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of neutral emotion.
Measured: 6 weeks
Mood 1: Motivation
Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)
Measured: 6 weeks
Mood 2: Bipolar Mood Dimension (Good-bad)
Assessed via the Mehrdimensionaler Befindlichkeitsfragebogen (MDBF) We analysed the bipolar mood dimension (good-bad) ranging from 4 (not at all good mood) to 20 (very good mood).
Measured: 6 weeks
Mood 3: Satisfaction Self-assessment
Assessed via visual analogue scale as rating by the therapist Satisfaction during the therapy sessions was assessed by the patient themselves using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).
Measured: 6 weeks
Mood 4: Satisfaction Therapist Rating
Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).
Measured: 6 weeks
Heart Rate
Assessed via EKG (Polar) during the sessions and measured in beat/min.
Measured: 6 weeks
Motor Activity
Assessed via actimeter at the patients wrist during sessions, measuring acceleration of the hand. It records data in 15-s epochs for maximum sensitivity. Data were calculated to yield average activity Counts per minute.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Social FunctioningStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Interdisciplinary Research on the Human-Pet Relationship
- Responsible party
- Principal investigator, Karin Hediger, Swiss Tropical & Public Health Institute
- Investigators
- Margret Hund-Georgiadis, PD Dr., Principal investigator, Rehab Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599766
- Sponsor's protocol ID
- Ref.Nr.EK:296/13
- Status last verified
- Apr 2019
- First submitted
- 29 Oct 2015
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29035068
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel
- ClinicalTrials.gov ID
- NCT02599766
- Acronym / sponsor ID
- Ref.Nr.EK:296/13
- Conditions
- Impaired Social Functioning
- Keywords
- animal assisted intervention, brain injury, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Institute for Interdisciplinary Research on the Human-Pet Relationship
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Posted 1 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| animal assisted therapy | Experimental | Other: animal assisted therapy"Standard therapy" that is done in the presence and with integrating an animal. |
| standard therapy | Active comparator | Other: standard therapy"Standard therapy" without the presence of an animal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 therapyphysiotherapy, speech therapy and occupational therapy in the presence of an animal | Other | animal assisted therapy |
| standard therapystandard physiotherapy, standard speech therapy and standard occupational therapy | Other | standard therapy |
Primary outcome
Social Functioning: Total Social Behavior
Time frame: 6 weeks
Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of all social behaviors are collected and aggregated to one measure, the total social behavior.
13 secondary outcomes
Social Functioning: Verbal Communication
Time frame: 6 weeks
Social Functioning: Nonverbal Communication
Time frame: 6 weeks
Social Functioning: Physical Contact
Time frame: 6 weeks
Social Functioning: Attention
Time frame: 6 weeks
Positive Emotional Display
Time frame: 6 weeks
Negative Emotional Display
Time frame: 6 weeks
Neutral Emotional Display
Time frame: 6 weeks
Mood 1: Motivation
Time frame: 6 weeks
Mood 2: Bipolar Mood Dimension (Good-bad)
Time frame: 6 weeks
Mood 3: Satisfaction Self-assessment
Time frame: 6 weeks
Mood 4: Satisfaction Therapist Rating
Time frame: 6 weeks
Heart Rate
Time frame: 6 weeks
Motor Activity
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29035068Gocheva 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.
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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.
Margret Hund-Georgiadis, PD Dr. principal investigator
Rehab Basel
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 and standard therapy in people with Impaired Social Functioning, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
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 4 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: finished, as of the sponsor's last update on 1 Jul 2019. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning: Total Social Behavior (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599766, which also lists 1 linked publication.
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 1 Jul 2019.