Ignite Creation Date:
2024-05-06 @ 12:17 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03729908
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2018-09-26
Brief Title:
Animal Assisted Mindfulness Intervention AAMI for Patients With Acquired Brain Injury
Sponsor:
Swiss Tropical Public Health Institute
Organization:
Swiss Tropical Public Health Institute
Study Overview
Official Title:
Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAMI
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 mindfulnessself-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 experimentalcontrol sessions each lasting for about 60 minutes
24 participants are planned to be included 12 patients in each group
In addition the effects on the patients symptoms of depression anxiety perceived stress mood coping and mindfulnessself-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 experimentalcontrol 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None