Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury

NCT ID: NCT03729908

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-09-12

Brief Summary

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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

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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

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Acquired Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Animal assisted mindfulness based intervention

Intervention Type BEHAVIORAL

A mindfulness based intervention in the presence of an animal

Anti-stress program

The active control intervention consists of the same program, however without the inclusion of animals (Anti-Stress program, ASP).

Group Type ACTIVE_COMPARATOR

Anti-stress program

Intervention Type BEHAVIORAL

A mindfulness based intervention with no reference to animals

Interventions

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Animal assisted mindfulness based intervention

A mindfulness based intervention in the presence of an animal

Intervention Type BEHAVIORAL

Anti-stress program

A mindfulness based intervention with no reference to animals

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rehab Basel

OTHER

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karin Hediger

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

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REHAB Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-00564

Identifier Type: -

Identifier Source: org_study_id

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