Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury (AAMI)
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|ClinicalTrials.gov Identifier: NCT03729908|
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : March 4, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Brain Injury||Behavioral: Animal assisted mindfulness based intervention Behavioral: Anti-stress program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||September 12, 2019|
|Actual Study Completion Date :||September 12, 2019|
Experimental: 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.
Behavioral: Animal assisted mindfulness based intervention
A mindfulness based intervention in the presence of an animal
Active Comparator: Anti-stress program
The active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP).
Behavioral: Anti-stress program
A mindfulness based intervention with no reference to animals
- 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)
- Depression [ Time Frame: 11 weeks ]Measured via BDI-FS (Beck Depression Inventory - Fast Screen for Medical Clients, without somatic items). The BDI-FS is a fast screen assessment of depression for medical patients. The minimum score is 0, the maximum score is 21, higher values represent a worse outcome.
- Perceived Stress [ Time Frame: 11 weeks ]Measured via the PSS-10-D (Perceived Stress Scale - 10). The Perceived Stress Scale was developed to measure the degree to which situations in one's life are appraised as stressful. The minimal total score is 1, the maximal total score is 40. Higher values represent worse outcome.
- Mindfulness [ Time Frame: 11 weeks ]Measured via the FFA-14 (Freiburger Fragebogen zur Achtsamkeit). Minimum total score is 0, maximum total score is 39. Higher values represent a better outcome.
- Self-compassion [ Time Frame: 11 weeks ]Measured via SCS-D Kurzversion (Self-compassion scale - Deutsch): Minimum total score is 1, maximum total score is 60, higher values represent a better outcome.
- Coping [ Time Frame: 11 weeks ]Measured via Brief COPE-G: The Brief COPE (-G, German version) Inventory is a multidimensional coping inventory to assess the different ways in which people respond to stress. It measures problem-focused coping, emotion-focused coping, and dysfunctional coping. Each subscale ranges between 1 and 8 with higher values representing higher scores in the respective coping strategy.
- Visual Analogue Scale (VAS) [ Time Frame: 11 weeks ]A VAS measuring motivation, emotion, cognition and attitude towards animals. The Visual Analogue Scales (VAS) provide a simple technique for measuring subjective experience and are continuous scales comprised of a horizontal line. Minimum score for each item is 0, maximum score is 160 with higher scores representing better outcomes.
- Mood [ Time Frame: 6 weeks ]Measured via the MDBF before and after each session: Mehrdimensionaler Befindlichkeitsfragebogen. The "Mehrdimensionaler Befindlichkeitsfragebogen" (MDBF) is a German-language instrument to assess the 3 mood dimensions pleasant-unpleasant, awake-sleepy, calm-restless and includes 24 items. Minimum score is 4, maximum score is 20.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729908
|Basel, BS, Switzerland, 4055|
|Principal Investigator:||Karin Hediger||University of Basel|