Long-term Effects of AAT in Patients With ABI
- Conditions
- Acquired Brain Injury
- Interventions
- Other: Animal-assisted therapyOther: Treatment as usual
- Registration Number
- NCT03687671
- Lead Sponsor
- Swiss Tropical & Public Health Institute
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- medical contraindications for contact with animals as allergy, phobia etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Animal-assisted therapy 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. Treatment as usual (activation program) Treatment as usual As control intervention patients receive treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy. The control intervention is named activation program.
- Primary Outcome Measures
Name Time Method socioemotional behaviour 18 weeks The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.
- Secondary Outcome Measures
Name Time Method Adherence to treatnemt 6 weeks Percentage of completed therapy sessions
Quality of life score 18 weeks Measured 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.Social cognition 18 weeks 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
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 motivation 18 weeks Measured 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.Depression 18 weeks 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
1. = agree little
2. = agree
3. = totally agree
Overall score range 0-21.
Trial Locations
- Locations (1)
REHAB Basel
🇨🇭Basel, BS, Switzerland