search
Back to results

Long-term Effects of AAT in Patients With ABI

Primary Purpose

Acquired Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Animal-assisted therapy
Treatment as usual
Sponsored by
Swiss Tropical & Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • REHAB BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Animal-assisted therapy

Treatment as usual (activation program)

Arm Description

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.

As control intervention patients receive treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy. The control intervention is named activation program.

Outcomes

Primary Outcome Measures

socioemotional behaviour
The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.

Secondary Outcome Measures

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.
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.
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.
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.
Adherence to treatnemt
Percentage of completed therapy sessions

Full Information

First Posted
September 26, 2018
Last Updated
September 27, 2023
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Rehab Basel, University of Basel
search

1. Study Identification

Unique Protocol Identification Number
NCT03687671
Brief Title
Long-term Effects of AAT in Patients With ABI
Official Title
Long-term Effects on Socioemotional Skills of Animal-assisted Therapy in Patients With Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Rehab Basel, University of Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Animal-assisted therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual (activation program)
Arm Type
Active Comparator
Arm Description
As control intervention patients receive treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy. The control intervention is named activation program.
Intervention Type
Other
Intervention Name(s)
Animal-assisted therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
activation program
Intervention Description
Speech therapy, occupational therapy or physiotherapy
Primary Outcome Measure Information:
Title
socioemotional behaviour
Description
The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Social cognition
Description
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.
Time Frame
18 weeks
Title
Therapy motivation
Description
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.
Time Frame
18 weeks
Title
Quality of life score
Description
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.
Time Frame
18 weeks
Title
Depression
Description
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.
Time Frame
18 weeks
Title
Adherence to treatnemt
Description
Percentage of completed therapy sessions
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Hediger, PhD
Phone
0041 79 519 78 85
Email
karin.hediger@unibas.ch
Facility Information:
Facility Name
REHAB Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4055
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Hediger, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Long-term Effects of AAT in Patients With ABI

We'll reach out to this number within 24 hrs