Long-term Effects of AAT in Patients With ABI

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03687671
• Other study ID #: 2018-01030
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: Swiss Tropical & Public Health Institute
• Contact: Karin Hediger, PhD
• Phone: 0041 79 519 78 85
• Email: karin.hediger[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

Intervention

Other:
• Animal-assisted therapy
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 usual
Speech therapy, occupational therapy or physiotherapy

Locations

Country	Name	City	State
Switzerland	REHAB Basel	Basel	BS

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Rehab Basel, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	socioemotional behaviour	The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.	18 weeks
Secondary	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: a) 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.	18 weeks
Secondary	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.	18 weeks
Secondary	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.	18 weeks
Secondary	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.	18 weeks
Secondary	Adherence to treatnemt	Percentage of completed therapy sessions	6 weeks