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Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury (AAMI)

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ClinicalTrials.gov Identifier: NCT03729908
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : March 4, 2020
Sponsor:
Collaborators:
Rehab Basel
University of Basel
University of Bern
Information provided by (Responsible Party):
Swiss Tropical & Public Health Institute

Brief Summary:

The aim of this study is to investigate the effect of an animal assisted mindfulness intervention (AAMI) on patients with acquired brain injuries on their global severity of psychological distress.

In addition, the effects on the patients' symptoms of depression, anxiety, perceived stress, mood, coping and mindfulness/self-compassion will be assessed.

The study experimental condition consists of 6 weeks of intervention, containing 6 different modules. In every session, an animal will be present.

In the control condition, the same program and same exercises will be used without the presence of or reference to animals. Sessions take place two times a week for 6 weeks (leading up to a total of 12 experimental/control sessions), each lasting for about 60 minutes.

24 participants are planned to be included, 12 patients in each group.


Condition or disease Intervention/treatment Phase
Acquired Brain Injury Behavioral: Animal assisted mindfulness based intervention Behavioral: Anti-stress program Not Applicable

Detailed Description:
It was estimated that a total sample of 24 participants (12 patients in each group) would provide enough power to detect a medium effect. Since we had several dropouts, two additional groups (one intervention and one control) were started. This lead to the inclusion of 31 participants with a total sample size of 25 participants finishing the program.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : September 12, 2019
Actual Study Completion Date : September 12, 2019

Arm Intervention/treatment
Experimental: Animal assisted mindfulness based intervention
The intervention is the AAMI. Trained animals that live in the "Therapie-Tiergarten" of REHAB Basel will function as therapy animals. Trained psychologists will lead the AAMI.
Behavioral: Animal assisted mindfulness based intervention
A mindfulness based intervention in the presence of an animal

Active Comparator: Anti-stress program
The active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP).
Behavioral: Anti-stress program
A mindfulness based intervention with no reference to animals




Primary Outcome Measures :
  1. General psychological distress [ Time Frame: 11 weeks ]
    Measured via BSI (Global Severity Index GSI). The Global Severity Index (GSI) is designed to help quantify a patient's severity-of-illness and provides a single composite score for measuring the outcome of a treatment program based on reducing symptom severity. Minimal total score = 0, maximal total score = 212 (higher values represent a worse outcome)


Secondary Outcome Measures :
  1. Depression [ Time Frame: 11 weeks ]
    Measured via BDI-FS (Beck Depression Inventory - Fast Screen for Medical Clients, without somatic items). The BDI-FS is a fast screen assessment of depression for medical patients. The minimum score is 0, the maximum score is 21, higher values represent a worse outcome.

  2. Perceived Stress [ Time Frame: 11 weeks ]
    Measured via the PSS-10-D (Perceived Stress Scale - 10). The Perceived Stress Scale was developed to measure the degree to which situations in one's life are appraised as stressful. The minimal total score is 1, the maximal total score is 40. Higher values represent worse outcome.

  3. Mindfulness [ Time Frame: 11 weeks ]
    Measured via the FFA-14 (Freiburger Fragebogen zur Achtsamkeit). Minimum total score is 0, maximum total score is 39. Higher values represent a better outcome.

  4. Self-compassion [ Time Frame: 11 weeks ]
    Measured via SCS-D Kurzversion (Self-compassion scale - Deutsch): Minimum total score is 1, maximum total score is 60, higher values represent a better outcome.

  5. Coping [ Time Frame: 11 weeks ]
    Measured via Brief COPE-G: The Brief COPE (-G, German version) Inventory is a multidimensional coping inventory to assess the different ways in which people respond to stress. It measures problem-focused coping, emotion-focused coping, and dysfunctional coping. Each subscale ranges between 1 and 8 with higher values representing higher scores in the respective coping strategy.

  6. Visual Analogue Scale (VAS) [ Time Frame: 11 weeks ]
    A VAS measuring motivation, emotion, cognition and attitude towards animals. The Visual Analogue Scales (VAS) provide a simple technique for measuring subjective experience and are continuous scales comprised of a horizontal line. Minimum score for each item is 0, maximum score is 160 with higher scores representing better outcomes.

  7. Mood [ Time Frame: 6 weeks ]
    Measured via the MDBF before and after each session: Mehrdimensionaler Befindlichkeitsfragebogen. The "Mehrdimensionaler Befindlichkeitsfragebogen" (MDBF) is a German-language instrument to assess the 3 mood dimensions pleasant-unpleasant, awake-sleepy, calm-restless and includes 24 items. Minimum score is 4, maximum score is 20.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of REHAB Basel
  • Acquired Brain Injury (ABI); FIM (Functional Independence Measure) cut-off score defined as > 60
  • Depressive or/and anxiety symptoms
  • Psychological difficulties coping with the actual life situation
  • 18 years or older
  • Willing to work with therapy animals
  • German speaking
  • Willingness to participate/informed consent

Exclusion Criteria:

  • Communication and articulation is not possible
  • Allergy to animals
  • Aversion against animals
  • Schizophrenic-related comorbidity
  • Mobilization to "Therapietiergarten" not possible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729908


Locations
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Switzerland
REHAB Basel
Basel, BS, Switzerland, 4055
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Rehab Basel
University of Basel
University of Bern
Investigators
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Principal Investigator: Karin Hediger University of Basel
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Responsible Party: Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03729908    
Other Study ID Numbers: 2018-00564
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System