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

Primary Purpose

Acquired Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Animal assisted mindfulness based intervention
Anti-stress program
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:

  • 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

Sites / Locations

  • REHAB Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Animal assisted mindfulness based intervention

Anti-stress program

Arm Description

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.

The active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP).

Outcomes

Primary Outcome Measures

General psychological distress
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

Depression
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.
Perceived Stress
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.
Mindfulness
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.
Self-compassion
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.
Coping
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.
Visual Analogue Scale (VAS)
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.
Mood
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.

Full Information

First Posted
September 26, 2018
Last Updated
March 2, 2020
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Rehab Basel, University of Basel, University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03729908
Brief Title
Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury
Acronym
AAMI
Official Title
Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
September 12, 2019 (Actual)

3. Sponsor/Collaborators

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

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 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.
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.

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
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Animal assisted mindfulness based intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Anti-stress program
Arm Type
Active Comparator
Arm Description
The active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP).
Intervention Type
Behavioral
Intervention Name(s)
Animal assisted mindfulness based intervention
Intervention Description
A mindfulness based intervention in the presence of an animal
Intervention Type
Behavioral
Intervention Name(s)
Anti-stress program
Intervention Description
A mindfulness based intervention with no reference to animals
Primary Outcome Measure Information:
Title
General psychological distress
Description
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)
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
11 weeks
Title
Perceived Stress
Description
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.
Time Frame
11 weeks
Title
Mindfulness
Description
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.
Time Frame
11 weeks
Title
Self-compassion
Description
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.
Time Frame
11 weeks
Title
Coping
Description
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.
Time Frame
11 weeks
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
11 weeks
Title
Mood
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Hediger
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
REHAB Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4055
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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