Dog Presence and Oxytocin on Trust Towards Therapists

Phase 2

Recruiting

• Conditions: Depressive Symptoms; Human-Animal Interaction
• Interventions: Drug: Oxytocin nasal spray; Other: Animal-Assisted Intervention; Drug: Placebo

• Registration Number: NCT06248710
• Lead Sponsor: Dr. Karin Hediger

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Study Start: 2024-01-29
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Condition 1: Oxytocin + dog present	Animal-Assisted Intervention	-
Condition 1: Oxytocin + dog present	Oxytocin nasal spray	-
Condition 2: Oxytocin + no dog present	Oxytocin nasal spray	-
Condition 3: Placebo + dog present	Animal-Assisted Intervention	-
Condition 3: Placebo + dog present	Placebo	-
Condition 4: Placebo + no dog present	Placebo	-

Primary Outcome Measures

Name	Time	Method
Trust in the therapist	immediately after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
therapeutic climate	immediately after the intervention	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.
Trust in the dog	immediately after the intervention	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.
therapeutic alliance	immediately after the intervention	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.
psychological flexibility	immediately after the intervention	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.
perceived emotional closeness to the dog	immediately after the intervention	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.
perceived stress	immediately after the intervention	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.
level of difficulty	immediately after the intervention	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.

Trial Locations

Locations (1)

University of Basel; 🇨🇭 Basel, Basel Stadt, Switzerland