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Recruiting NCT06248710

Dog Presence and Oxytocin on Trust Towards Therapists

Phase II / Phase III Interventional Depressive Symptoms Human-Animal Interaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxytocin nasal spray, Animal-Assisted Intervention, Placebo.
Who it may be relevant to
Registry conditions: Depressive Symptoms, Human-Animal Interaction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Intranasal Oxytocin on Trust Towards Therapists and Dogs: A Randomized Controlled Trial in Healthy Adults

Overview

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.

Interventions

  • Drug Oxytocin nasal spray
    Syntocinon nose spray is usually applied in the context of labour and breast feeding. In this study, however, it will be used to induce an oxytocin (OT) release. Participants will apply three sprays in each nostril which will result in a dose of 24 I.U of oxytocin per participant
  • Other Animal-Assisted Intervention
    The dogs involved in the study are trained and used to work with different people in animal-assisted interventions. The dog will be familiarized with the room and the material as well as the staff of the study. The dog will be specifically trained for this study. The dog will be involved for a maximum of 3 sessions per day (approx. 20 minutes in total) and 2 days per week.
  • Drug Placebo
    The placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin.

Primary outcome measures

  • Trust in the therapist [Time frame: immediately after the intervention]
Secondary outcome measures (9)
  • Trust in the dog [Time frame: immediately after the intervention]
  • perceived emotional closeness to the dog [Time frame: immediately after the intervention]
  • perceived stress [Time frame: pre-intervention]
  • perceived stress [Time frame: immediately after the intervention]
  • level of difficulty [Time frame: immediately after the intervention]
  • therapeutic alliance [Time frame: immediately after the intervention]
  • therapeutic climate [Time frame: immediately after the intervention]
  • psychological flexibility [Time frame: pre-intervention]
  • psychological flexibility [Time frame: immediately after the intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Switzerland · 1 center
  • University of Basel — Basel

Publications

  • Algoe SB, Kurtz LE, Grewen K. Oxytocin and Social Bonds: The Role of Oxytocin in Perceptions of Romantic Partners' Bonding Behavior. Psychol Sci. 2017 Dec;28(12):1763-1772. doi: 10.1177/0956797617716922. Epub 2017 Oct 2. PMID 28968183
  • Bakermans-Kranenburg MJ, van I Jzendoorn MH. Sniffing around oxytocin: review and meta-analyses of trials in healthy and clinical groups with implications for pharmacotherapy. Transl Psychiatry. 2013 May 21;3(5):e258. doi: 10.1038/tp.2013.34. PMID 23695233
  • Feldman R, Weller A, Zagoory-Sharon O, Levine A. Evidence for a neuroendocrinological foundation of human affiliation: plasma oxytocin levels across pregnancy and the postpartum period predict mother-infant bonding. Psychol Sci. 2007 Nov;18(11):965-70. doi: 10.1111/j.1467-9280.2007.02010.x. PMID 17958710
  • Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701. PMID 15931222
  • Nagasawa M, Mitsui S, En S, Ohtani N, Ohta M, Sakuma Y, Onaka T, Mogi K, Kikusui T. Social evolution. Oxytocin-gaze positive loop and the coevolution of human-dog bonds. Science. 2015 Apr 17;348(6232):333-6. doi: 10.1126/science.1261022. Epub 2015 Apr 16. PMID 25883356
  • 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
  • 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. PMID 31888759
  • 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.

Identifiers

NCT: NCT06248710 · 2023-00523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗