Acquired Brain InjuryAAMINCT03729908
Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury
A study testing Animal assisted mindfulness based intervention and Anti-stress program in people with Acquired Brain Injury, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Animal assisted mindfulness based intervention and Anti-stress program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2018to 12 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Communication and articulation is not possible
- Allergy to animals
- Aversion against animals
- Schizophrenic-related comorbidity
- Mobilization to "Therapietiergarten" not possible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial
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.
Read more
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.
Read the 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
- Acquired Brain Injury
- Being tested
- Animal assisted mindfulness based intervention, Anti-stress program
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal assisted mindfulness based interventionBehavioural
A mindfulness based intervention in the presence of an animal
Anti-stress programBehavioural
A mindfulness based intervention with no reference to animals
| Study group | Role | What they receive |
|---|---|---|
| Animal assisted mindfulness based intervention | Experimental | 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. Receives: Behavioral: Animal assisted mindfulness based intervention |
| Anti-stress program | Active comparator | The active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP). Receives: Behavioral: Anti-stress program |
What is being measured
The primary outcome is the main question the study is designed to answer.
General psychological distress
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)
Measured: 11 weeks
Secondary outcomes (7)
Depression
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.
Measured: 11 weeks
Perceived Stress
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.
Measured: 11 weeks
Mindfulness
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.
Measured: 11 weeks
Self-compassion
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.
Measured: 11 weeks
Coping
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.
Measured: 11 weeks
Visual Analogue Scale (VAS)
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.
Measured: 11 weeks
Mood
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Jun 2018
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rehab Basel, University of Basel, University of Bern
- Responsible party
- Sponsor
- Investigators
- Karin Hediger, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729908
- Sponsor's protocol ID
- 2018-00564
- Other IDs
- 2018
- Acronym
- AAMI
- Status last verified
- Jan 2020
- First submitted
- 26 Sep 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03729908
- Acronym / sponsor ID
- AAMI / 2018-00564
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Rehab Basel, University of Basel, University of Bern
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal assisted mindfulness based intervention | Experimental | Behavioral: Animal assisted mindfulness based interventionThe 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. |
| Anti-stress program | Active comparator | Behavioral: Anti-stress programThe active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Communication and articulation is not possible
- Allergy to animals
- Aversion against animals
- Schizophrenic-related comorbidity
- Mobilization to "Therapietiergarten" not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal assisted mindfulness based interventionA mindfulness based intervention in the presence of an animal | Behavioural | Animal assisted mindfulness based intervention |
| Anti-stress programA mindfulness based intervention with no reference to animals | Behavioural | Anti-stress program |
Primary outcome
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)
7 secondary outcomes
Depression
Time frame: 11 weeks
Perceived Stress
Time frame: 11 weeks
Mindfulness
Time frame: 11 weeks
Self-compassion
Time frame: 11 weeks
Coping
Time frame: 11 weeks
Visual Analogue Scale (VAS)
Time frame: 11 weeks
Mood
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Hediger principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal assisted mindfulness based intervention and Anti-stress program in people with Acquired Brain Injury, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General psychological distress (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.