Dog Presence and Oxytocin on Trust Towards Therapists (DOT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Symptoms; Human-Animal Interaction
• Intervention / Treatment: Drug: Oxytocin nasal spray; Other: Animal-Assisted Intervention; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Karin Hediger, Prof. Dr.; Phone Number: +41 (0)61 207 65 80; Email: elena.pauli@unibas.ch
• Study Contact Backup: Name: Elena Pauli, MSc; Phone Number: +41 (0)61 207 69 58; Email: elena.pauli@unibas.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condition 1: Oxytocin + dog present	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.
Experimental: Condition 2: Oxytocin + no dog present	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
Experimental: Condition 3: Placebo + dog present	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.
Placebo Comparator: Condition 4: Placebo + no dog present	Drug: Placebo; The placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trust in the dog	The secondary outcome "trust in the dog" will be measured with a Visual Analog Scale (VAS). The following extremes will be used: no trust to complete trust. High values indicate high trust in the dog.	immediately after the intervention
perceived emotional closeness to the dog	The Coleman Dog Attitude Scale (C-DAS) is a reliable and validated measure designed to assess attitudes towards dogs. The C-DAS is a 24-item self-report measure with an alpha ranging from 0.98 to 0.99.	immediately after the intervention
perceived stress	The secondary outcome "perceived stress" will be measured with a Visual Analog Scale (VAS). The following extremes will be used: no stress to extreme stress. High values indicate that participants perceive a lot of stress.	pre-intervention
perceived stress	The secondary outcome "perceived stress" will be measured with a Visual Analog Scale (VAS). The following extremes will be used: no stress to extreme stress. High values indicate that participants perceive a lot of stress.	immediately after the intervention
level of difficulty	The secondary outcome "level of difficulty" in talking about a selected stressful event will be measured with a Visual Analog Scale (VAS). The following extremes will be used: no difficulty to extreme difficulty. High values indicate that participants find it extremely difficult to talk about a selected stressful event.	immediately after the intervention
therapeutic alliance	The Therapy Session Questionnaire (in German "Therapiesitzungsbogen für Patienten und Therapeuten") will be used to assess the secondary outcome of "therapeutic alliance". The current questionnaire contains 20 items. Each item is measured on a 7-point Likert scale (-3 = "not at all" to +3 = "yes, exactly"). High values indicate high therapeutic alliance.	immediately after the intervention
therapeutic climate	Therapy Session Questionnaire (in German "Therapiesitzungsbogen für Patienten und Therapeuten") will be used to assess the secondary outcome of "therapeutic climate". The current questionnaire contains 20 items. Each item is measured on a 7-point Likert scale (-3 = "not at all" to +3 = "yes, exactly"). High values indicate a good therapeutic climate.	immediately after the intervention
psychological flexibility	The secondary outcome "psychological flexibility" will be measured with the psychological flexibility questionnaire (Psy-Flex). The Psy-Flex questionnaire consists of six items, which are representative for the six skills. Items are rated on a Likert scale (5 = "very often" to 1 = "very rarely") and are then summed up. Higher scores represent higher psychological flexibility.	pre-intervention
psychological flexibility	The secondary outcome "psychological flexibility" will be measured with the psychological flexibility questionnaire (Psy-Flex). The Psy-Flex questionnaire consists of six items, which are representative for the six skills. Items are rated on a Likert scale (5 = "very often" to 1 = "very rarely") and are then summed up. Higher scores represent higher psychological flexibility.	immediately after the intervention

Collaborators and Investigators

• Sponsor: Dr. Karin Hediger

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): January 29, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depressive Symptoms; Trust; Human-Animal Interaction; Animal-Assisted Interventions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: DOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are planning on sharing the anonymized data on a openly assess platform.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No