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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Animal assisted mindfulness based intervention | A mindfulness based intervention in the presence of an animal |
| BEHAVIORAL | Anti-stress program | A 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.