Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- General psychological distress
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Animal assisted mindfulness based intervention (Behavioral)
Anti-stress program
The active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP).
Intervention: Anti-stress program (Behavioral)
Outcomes
Primary Outcomes
General psychological distress
Time Frame: 11 weeks
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)
Secondary Outcomes
- Depression(11 weeks)
- Self-compassion(11 weeks)
- Coping(11 weeks)
- Perceived Stress(11 weeks)
- Mindfulness(11 weeks)
- Visual Analogue Scale (VAS)(11 weeks)
- Mood(6 weeks)