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

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 Overview

• Status: Completed
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Other: Animal-assisted therapy; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4055
      • REHAB Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Animal-assisted therapy; 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.	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.
Active Comparator: Treatment as usual (activation program); As control intervention patients receive treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy. The control intervention is named activation program.	Other: Treatment as usual; Speech therapy, occupational therapy or physiotherapy; Other Names: activation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
socioemotional behaviour	The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Adherence to treatnemt	Percentage of completed therapy sessions	6 weeks

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Rehab Basel; University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 2018-01030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No