Dog Presence and Oxytocin on Trust Towards Therapists

NCT06248710 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-00523
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Human-Animal Interaction

Keywords

Depressive Symptoms; Human-Animal Interaction; Animal-Assisted Interventions; Trust

Outcome Measures

Primary Outcomes (1)

• Trust in the therapist

  The main outcome is trust in the therapist, measured by the Trust and Respect Scale. The current questionnaire contains 8 items, four for trust and four for respect. Each item is measured on a 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree"), of which 4 are formulated negatively. High values indicate high trust toward the therapist for the positively framed items, and for the negatively framed items low values mean high trust toward the therapist.

  immediately after the intervention

Secondary Outcomes (9)

• Trust in the dog

  immediately after the intervention

• perceived emotional closeness to the dog

  immediately after the intervention

• perceived stress

  pre-intervention

• perceived stress

  immediately after the intervention

• level of difficulty

  immediately after the intervention

Study Arms (4)

Condition 1: Oxytocin + dog present

EXPERIMENTAL

Drug: Oxytocin nasal spray; Other: Animal-Assisted Intervention

Condition 2: Oxytocin + no dog present

EXPERIMENTAL

Drug: Oxytocin nasal spray

Condition 3: Placebo + dog present

EXPERIMENTAL

Other: Animal-Assisted Intervention; Drug: Placebo

Condition 4: Placebo + no dog present

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

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

Condition 1: Oxytocin + dog present; Condition 2: Oxytocin + no dog present

Animal-Assisted Intervention OTHER

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.

Condition 1: Oxytocin + dog present; Condition 3: Placebo + dog present

Placebo DRUG

The placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin.

Condition 3: Placebo + dog present; Condition 4: Placebo + no dog present

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Karin Hediger: lead

Study Sites (1)

University of Basel

Basel, Canton of Basel-City, 4055, Switzerland

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Depression; Human-Animal Interaction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Karin Hediger, Prof. Dr.

CONTACT

+41 (0)61 207 65 80; elena.pauli@unibas.ch

Elena Pauli, MSc

CONTACT

+41 (0)61 207 69 58; elena.pauli@unibas.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Karin Hediger

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 8, 2024
• Study Start: January 29, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

CH (1)