Clinical Trials Directory

Trials / Completed

CompletedNCT03729908

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
31 (actual)
Sponsor
Swiss Tropical & Public Health Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAnimal assisted mindfulness based interventionA mindfulness based intervention in the presence of an animal
BEHAVIORALAnti-stress programA mindfulness based intervention with no reference to animals

Timeline

Start date
2018-06-01
Primary completion
2019-09-12
Completion
2019-09-12
First posted
2018-11-05
Last updated
2020-03-04

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03729908. Inclusion in this directory is not an endorsement.