Clinical trial NCT06248710: Dog Presence and Oxytocin on Trust Towards Therapists
Official title: Effects of Intranasal Oxytocin on Trust Towards Therapists and Dogs: A Randomized Controlled Trial in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Depressive Symptoms
Human-Animal Interaction
Keywords: Depressive Symptoms
Human-Animal Interaction
Animal-Assisted Interventions
Trust
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Oxytocin has been proposed as a neuroendocrine mechanism that may mediate the relationship between dog ownership and positive health outcomes and be linked to human-dog interactions and is thought to be a mechanism of interspecies bonding. While the role of oxytocin in human bonding behaviours and social behaviour, in general, is becoming well-established the role of oxytocin in human-animal interaction and Animal-Assisted Interventions (AAI) remains unclear. This research gap calls for more high-quality research investigating this possible neuroendocrine underlying mechanism to advance knowledge about AAI. If oxytocin indeed might be involved in interspecies bonding, intranasally administered oxytocin should not only enhance trust toward a human but also towards a dog.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Being scared of dogs or dog hair allergy by self-report
* Any acute or chronic disease (e.g., chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes, respiratory disease, skin pathologies etc.)
* Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
* Drug consumption (THC, cocaine, heroin, etc.) within the past 24h before study appointment
* Ongoing psychotherapy treatment
* Sexual Intercourse within the past 24h before study appointment
* Current disease involving respiratory system (e.g., influence, asthma etc.)
* Insufficient German language skills to understand the instructions

Primary outcomes:
measure: Trust in the therapist
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Trust in the dog
timeFrame: immediately after the intervention
measure: perceived emotional closeness to the dog
timeFrame: immediately after the intervention
measure: perceived stress
timeFrame: pre-intervention
measure: perceived stress
timeFrame: immediately after the intervention
measure: level of difficulty
timeFrame: immediately after the intervention
measure: therapeutic alliance
timeFrame: immediately after the intervention
measure: therapeutic climate
timeFrame: immediately after the intervention
measure: psychological flexibility
timeFrame: pre-intervention
measure: psychological flexibility
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
state: Basel Stadt
Study officials:
References:
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citation: Powell, L., Guastella, A. J., McGreevy, P. D., Bauman, A., Edwards, K. M., & Stamatakis, E. (2018). The physiological function of oxytocin in humans and its acute response to human-dog interactions: A review of the literature. Journal of Veterinary Behavior, 30, 25-32. https://doi.org/10.1016/j.jveb.2018.10.008
citation: Crits-Christoph P, Rieger A, Gaines A, Gibbons MBC. Trust and respect in the patient-clinician relationship: preliminary development of a new scale. BMC Psychol. 2019 Dec 30;7(1):91. doi: 10.1186/s40359-019-0347-3.
citation: Coleman, J. A., Green, B., Garthe, R. C., Worthington Jr, E. L., Barker, S. B., & Ingram, K. M. (2016). The Coleman Dog Attitude Scale (C-DAS): development, refinement, validation, and reliability. Applied Animal Behaviour Science, 176, 77-86.
citation: Gloster, A. T., Block, V. J., Klotsche, J., Villanueva, J. E., Rinner, M. T. B., Benoy, C., Walter, M., Karekla, M., & Bader, K. (2021). Psy-Flex: A contextually sensitive measure of psychological flexibility. Journal of Contextual Behavioral Science, 22, 13-23. https://doi.org/10.1016/j.jcbs.2021.09.001