Acquired Brain InjuryNCT03687671
Long-term Effects of AAT in Patients With ABI
A study testing Animal-assisted therapy and Treatment as usual in people with Acquired Brain Injury, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
Trial summary
The aim of this study is to investigate weather patients treated with animal-assisted therapy show better socioemotional skills compared to treatment as usual. 70 patients will be allocated randomly to one of two groups (control group and intervention group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Animal-assisted therapy and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 20 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent as documented signed by the patient or his/her legal representative
- Inpatients of REHAB Basel with acquired brain injury and FIM-score over 60 (Funktionale Selbstständigkeitsmessung, Internationale Vereinigung für Assessment in der Rehabilitation, 1997)
- Minimum age of 18 years
Who cannot join
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- medical contraindications for contact with animals as allergy, phobia etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects on Socioemotional Skills of Animal-assisted Therapy in Patients With Acquired Brain Injury
The aim of this study is to investigate weather patients treated with animal-assisted therapy show better socioemotional skills compared to treatment as usual.
70 patients will be allocated randomly to one of two groups (control group and intervention group). During 6 weeks, all patients get two therapy sessions (AAT vs. TAU) per week. The 35 patients in the control group will get treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy twice a week whereas the 35 patients in the intervention group will get the same therapies but there will be an animal included in the therapy sessions.
Read more
The main outcome is the amount of expressed emotion and interaction in a standardized social situation measured via behavioral video coding.
Measurements will be done before the first therapy session (pre-measurement, t0) and after the last therapy session (post-measurement, t1) of the 6 weeks of intervention. The follow-up measurement will be done 6 weeks (follow-up I, t2) and 12 weeks later (follow-up II, t3).
- Conditions
- Acquired Brain Injury
- Being tested
- Animal-assisted therapy, Treatment as usual
- 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
Animal-assisted occupational therapy, animal-assisted physiotherapy and animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses.
Treatment as usualOther
Also called activation program
Speech therapy, occupational therapy or physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Animal-assisted therapy | Experimental | The intervention is animal-assisted occupational therapy, animal-assisted physiotherapy or animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses. Receives: Other: Animal-assisted therapy |
| Treatment as usual (activation program) | Active comparator | As control intervention patients receive treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy. The control intervention is named activation program. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
socioemotional behaviour
The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.
Measured: 18 weeks
Secondary outcomes (5)
Social cognition
Measured via the "Movie for the Assessment of Social Cognition" MASC, Movie for the assessment of social cognition
The MASC is a video based test, where 46 questions need to be answered. Correct answer = 1 point, incorrect answer = 0 point. The more questions are answered correctly the merrier the results are.
Each question has four answer options. Each option has its own signification:
- correct ToM, b) exceeding ToM, c) less ToM, d) no ToM
- Emotion: 17 items, total score range 0-17
- Intention: 18 items, total score range 0-18
- Thoughts: 7 items, total score range 0-7
Overall score range 0-46. The higher the score, the higher the capability of theory of mind (ToM).
There is a rage of 30-39 right answered questions in healthy populations.
Measured: 18 weeks
Therapy motivation
Measured with the questionnaire FPTM
FPTM: Fragebogen zur Erfassung der Psychotherapiemotivation.
Questionnaire measuring psychotherapy motivation with 39 items and 6 subscales:
- Physiological strain (Psychischer Ledensdruck): 10 itmens, total score range 10-40
- Hope for improvement (Hoffnung): 7 items, total score range 7-28
- Refuse of psychological need (Verneinung psychischer Hilfsbedürftigkeit): 7 items, score range 7-28
- Knowledge about treatment (Wissen): 5 items, total score range 5-20
- Initiative for treatment (Initiative): 4 items, total score range 4-16
- Symptom based care through others (Symptombezogene Zuwendung durch andere): 6 itmens, sore range 6-36
Each question needs to be ranged from 1 to 4, high number mean higher motivation:
- = don't agree at all
- = don't agree
- = agree
- = totally agree
Overall score range 39-156.
Measured: 18 weeks
Quality of life score
Measured via the WHOQL-BREF
WHOQL_BREF, World Health Organization Quality of Life
Questionnaire about quality of life with 26 questions and four subscales:
- Physical health (Physische Gesundheit): 7 items, total score range 7-35
- Psychological health (Psychologische Gesundheit): 6 items, total score range 6-30
- Social relationship (Soziale Beziheungen): 3 items, total score range 3-15
- Environment (Umwelt): 8 items, total score range 8-40
Each question needs to be ranged from 1 to 5, high number mean higher quality of life.
- = don't agree at all
- = don't agree
- = neutral
- = agree
- = totally agree
Overall score range 26-130.
Measured: 18 weeks
Depression
Measured via the BDI-FS
BDI-FS, Beck Depressions-Inventar Fast Screening Questionnaire with 7 questions about negative feelings who need to be ranged from 0-3. High number mean higher rates in depression.
0 = don't agree
- = agree little
- = agree
- = totally agree
Overall score range 0-21.
Measured: 18 weeks
Adherence to treatnemt
Percentage of completed therapy sessions
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 posted27 Sep 2018
- Study start1 Nov 2018
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rehab Basel, University of Basel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687671
- Sponsor's protocol ID
- 2018-01030
- Other IDs
- 2018
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2018
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pauli E, Dubach S, Haase C, Haefeli A, Hund-Georgiadis M, Hattendorf J, Hediger K. Transfer effects of animal-assisted therapy on socioemotional skills in adult inpatient rehabilitation after acquired brain injury: a randomized controlled trial. Front Rehabil Sci. 2026 Sep 3;7:1818862. doi: 10.3389/fresc.2026.1818862. eCollection 2026.
PubMed 42757242
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects on Socioemotional Skills of Animal-assisted Therapy in Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03687671
- Acronym / sponsor ID
- 2018-01030
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Rehab Basel, University of Basel
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 27 Sep 2018 (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.
The aim of this study is to investigate weather patients treated with animal-assisted therapy show better socioemotional skills compared to treatment as usual.
70 patients will be allocated randomly to one of two groups (control group and intervention group). During 6 weeks, all patients get two therapy sessions (AAT vs. TAU) per week. The 35 patients in the control group will get treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy twice a week whereas the 35 patients in the intervention group will get the same therapies but there will be an animal included in the therapy sessions.
The main outcome is the amount of expressed emotion and interaction in a standardized social situation measured via behavioral video coding.
Measurements will be done before the first therapy session (pre-measurement, t0) and after the last therapy session (post-measurement, t1) of the 6 weeks of intervention. The follow-up measurement will be done 6 weeks (follow-up I, t2) and 12 weeks later (follow-up II, t3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted therapy | Experimental | Other: Animal-assisted therapyThe intervention is animal-assisted occupational therapy, animal-assisted physiotherapy or animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses. |
| Treatment as usual (activation program) | Active comparator | Other: Treatment as usualAs control intervention patients receive treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy. The control intervention is named activation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent as documented signed by the patient or his/her legal representative
- Inpatients of REHAB Basel with acquired brain injury and FIM-score over 60 (Funktionale Selbstständigkeitsmessung, Internationale Vereinigung für Assessment in der Rehabilitation, 1997)
- Minimum age of 18 years
Key exclusion criteria (2 listed)
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- medical contraindications for contact with animals as allergy, phobia etc.
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 occupational therapy, animal-assisted physiotherapy and animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses. | Other | Animal-assisted therapy |
| Treatment as usualAlso: activation programSpeech therapy, occupational therapy or physiotherapy | Other | Treatment as usual (activation program) |
Primary outcome
socioemotional behaviour
Time frame: 18 weeks
The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.
5 secondary outcomes
Social cognition
Time frame: 18 weeks
Therapy motivation
Time frame: 18 weeks
Quality of life score
Time frame: 18 weeks
Depression
Time frame: 18 weeks
Adherence to treatnemt
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 42757242Pauli E, Dubach S, Haase C, Haefeli A, Hund-Georgiadis M, Hattendorf J, Hediger K. Transfer effects of animal-assisted therapy on socioemotional skills in adult inpatient rehabilitation after acquired brain injury: a randomized controlled trial. Front Rehabil Sci. 2026 Sep 3;7:1818862. doi: 10.3389/fresc.2026.1818862. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Treatment as usual in people with Acquired Brain Injury, 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 3 inclusion and 2 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 5 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
socioemotional behaviour (time frame: 18 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 NCT03687671, 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 5 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.