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Long-term Effects of AAT in Patients With ABI

Long-term Effects on Socioemotional Skills of Animal-assisted Therapy in Patients With Acquired Brain Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03687671
Enrollment
70
Registered
2018-09-27
Start date
2018-11-01
Completion date
2024-06-20
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury

Brief 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). 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).

Interventions

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.

OTHERTreatment as usual

Speech therapy, occupational therapy or physiotherapy

Sponsors

Rehab Basel
CollaboratorOTHER
University of Basel
CollaboratorOTHER
Swiss Tropical & Public Health Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Enrolment of the investigator, his/her family members, employees and other dependent persons * medical contraindications for contact with animals as allergy, phobia etc.

Design outcomes

Primary

MeasureTime frameDescription
socioemotional behaviour18 weeksThe amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.

Secondary

MeasureTime frameDescription
Social cognition18 weeksMeasured 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: a) correct ToM, b) exceeding ToM, c) less ToM, d) no ToM 1. Emotion: 17 items, total score range 0-17 2. Intention: 18 items, total score range 0-18 3. 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.
Therapy motivation18 weeksMeasured with the questionnaire FPTM FPTM: Fragebogen zur Erfassung der Psychotherapiemotivation. Questionnaire measuring psychotherapy motivation with 39 items and 6 subscales: 1. Physiological strain (Psychischer Ledensdruck): 10 itmens, total score range 10-40 2. Hope for improvement (Hoffnung): 7 items, total score range 7-28 3. Refuse of psychological need (Verneinung psychischer Hilfsbedürftigkeit): 7 items, score range 7-28 4. Knowledge about treatment (Wissen): 5 items, total score range 5-20 5. Initiative for treatment (Initiative): 4 items, total score range 4-16 6. 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: 1. = don't agree at all 2. = don't agree 3. = agree 4. = totally agree Overall score range 39-156.
Quality of life score18 weeksMeasured via the WHOQL-BREF WHOQL\_BREF, World Health Organization Quality of Life Questionnaire about quality of life with 26 questions and four subscales: 1. Physical health (Physische Gesundheit): 7 items, total score range 7-35 2. Psychological health (Psychologische Gesundheit): 6 items, total score range 6-30 3. Social relationship (Soziale Beziheungen): 3 items, total score range 3-15 4. 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. 1. = don't agree at all 2. = don't agree 3. = neutral 4. = agree 5. = totally agree Overall score range 26-130.
Depression18 weeksMeasured 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 1. = agree little 2. = agree 3. = totally agree Overall score range 0-21.
Adherence to treatnemt6 weeksPercentage of completed therapy sessions

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026