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

Swiss Tropical and Public Health (TPH) Institute

Status: Completed

Conditions: Acquired Brain Injury

Treatments: Behavioral: Anti-stress program; Behavioral: Animal assisted mindfulness based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03729908

2018-00564

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

Animal assisted mindfulness based intervention

Experimental group

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.

Treatment:

Behavioral: Animal assisted mindfulness based intervention

Anti-stress program

Active Comparator group

Description:

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

Treatment:

Behavioral: Anti-stress program