Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06248710

Dog Presence and Oxytocin on Trust Towards Therapists

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Human-Animal Interaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Placebo

Drug

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

Primary outcomes

  1. Trust in the therapist

    Time frame: 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 outcomes

  1. Trust in the dog

    Time frame: 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.

  2. perceived emotional closeness to the dog

    Time frame: 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.

  3. perceived stress

    Time frame: pre-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.

  4. perceived stress

    Time frame: 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.

  5. level of difficulty

    Time frame: 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.

  6. therapeutic alliance

    Time frame: 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.

  7. therapeutic climate

    Time frame: 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.

  8. psychological flexibility

    Time frame: pre-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.

  9. psychological flexibility

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Pauli, MSc

CONTACT

[email protected]

+41 (0)61 207 69 58

Karin Hediger, Prof. Dr.

CONTACT

[email protected]

+41 (0)61 207 65 80

Sponsors and collaborators

Lead sponsor

Dr. Karin Hediger

Other

Registry information

Official study title

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

Acronym: DOT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.