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Trial · Interventional

RecruitingPhase 2/3Registry data

Dog Presence and Oxytocin on Trust Towards Therapists

Short name DOT

NCTNCT06248710 (opens ClinicalTrials.gov in a new tab)Other id2023-00523Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2/3
Enrollment
176 participants (estimated)
Sponsor
Dr. Karin Hediger · Other
Design
Randomized · Quadruple masking
Countries
1 country

Switzerland

Start
29 Jan 2024
Primary completion
31 Dec 2024 (estimated)
Completion
31 Dec 2024 (estimated)
First posted
8 Feb 2024
Last update posted
5 Nov 2024
Conditions
Depressive Symptoms · Human-Animal Interaction

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025
  1. Ph 2/3

    DOT

    NCT06248710

    29 Jan 2024 to est. 31 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Oxytocin nasal sprayDrug
  • Animal-Assisted InterventionOther
  • PlaceboDrug

Arms4

  • Experimental

    Condition 1: Oxytocin + dog present

  • Experimental

    Condition 2: Oxytocin + no dog present

  • Experimental

    Condition 3: Placebo + dog present

  • Placebo comparator

    Condition 4: Placebo + no dog present

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Trust in the therapist

    Time frame · immediately after the intervention

    Registry description

    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(9)

  1. Trust in the dog

    Time frame · immediately after the intervention

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2013

3 results

Sniffing around oxytocin: review and meta-analyses of trials in healthy and clinical groups with implications for pharmacotherapy.

Bakermans-Kranenburg et al. 2013Translational psychiatrycited by 304

PMID 23695233PMC3669921DOI 10.1038/tp.2013.34PUB-23695233

Free to read · publisher termsCC BY-NC-ND3 results
Read at sourceSee results (3)

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

3 studies on this page

PubMed tag: none · 2017

Oxytocin and Social Bonds: The Role of Oxytocin in Perceptions of Romantic Partners' Bonding Behavior.

Algoe et al. 2017Psychological sciencecited by 50

PMID 28968183PMC5734372DOI 10.1177/0956797617716922PUB-28968183

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2015

Social evolution. Oxytocin-gaze positive loop and the coevolution of human-dog bonds.

Nagasawa et al. 2015Science (New York, N.Y.)cited by 380

PMID 25883356DOI 10.1126/science.1261022PUB-25883356

Full text at the publisher
Publisher page

PubMed tag: none · 2007

Evidence for a neuroendocrinological foundation of human affiliation: plasma oxytocin levels across pregnancy and the postpartum period predict mother-infant bonding.

Feldman et al. 2007Psychological sciencecited by 474

PMID 17958710DOI 10.1111/j.1467-9280.2007.02010.xPUB-17958710

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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