NCT03729908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2019

Completed
Last Updated

March 4, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

September 26, 2018

Last Update Submit

March 2, 2020

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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)

    11 weeks

Secondary Outcomes (7)

  • Depression

    11 weeks

  • Perceived Stress

    11 weeks

  • Mindfulness

    11 weeks

  • Self-compassion

    11 weeks

  • Coping

    11 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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).

Behavioral: Anti-stress program

Interventions

Animal assisted mindfulness based interventionBEHAVIORAL

A mindfulness based intervention in the presence of an animal

Animal assisted mindfulness based intervention
Anti-stress programBEHAVIORAL

A mindfulness based intervention with no reference to animals

Anti-stress program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older
  • Willing to work with therapy animals
  • German speaking
  • Willingness to participate/informed consent

You may not qualify if:

  • Communication and articulation is not possible
  • Allergy to animals
  • Aversion against animals
  • Schizophrenic-related comorbidity
  • Mobilization to "Therapietiergarten" not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REHAB Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Karin Hediger

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

November 5, 2018

Study Start

June 1, 2018

Primary Completion

September 12, 2019

Study Completion

September 12, 2019

Last Updated

March 4, 2020

Record last verified: 2020-01

Locations

CH(1)