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Completed

NCT Number: NCT03687671

Long-term Effects of AAT in Patients With ABI

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).

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REHAB Basel

Basel, Canton of Basel-City, 4055, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Animal-assisted therapy

Other

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

Other

Speech therapy, occupational therapy or physiotherapy

Other names: activation program

Primary outcomes

  1. socioemotional behaviour

    Time frame: 18 weeks

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

Secondary outcomes

  1. Social cognition

    Time frame: 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

    • 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.

  2. Therapy motivation

    Time frame: 18 weeks

    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.

  3. Quality of life score

    Time frame: 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:

    • 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.

  4. Depression

    Time frame: 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

    • = agree little
    • = agree
    • = totally agree

    Overall score range 0-21.

  5. Adherence to treatnemt

    Time frame: 6 weeks

    Percentage of completed therapy sessions

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Rehab Basel
  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2018
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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