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

Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Behavioral: Animal assisted mindfulness based intervention; Behavioral: Anti-stress program

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4055
      • REHAB Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	11 weeks
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.	11 weeks
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.	11 weeks
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.	11 weeks
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.	11 weeks
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.	11 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: University of Bern; Rehab Basel; University of Basel
• Investigators: Principal Investigator: Karin Hediger, University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): September 12, 2019

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 2018-00564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No