Depressive SymptomsPhase 2/3DOTNCT06248710
Dog Presence and Oxytocin on Trust Towards Therapists
A Phase 2/3 study testing Oxytocin nasal spray and Animal-Assisted Intervention in people with Depressive Symptoms and Human-Animal Interaction, run by Dr. Karin Hediger at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Human-Animal Interaction
- What is being tested?
- Oxytocin nasal spray and Animal-Assisted Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jan 2024to 31 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Signed informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel
Basel, Canton of Basel-City, 4055
Karin Hediger, +41795197885, karin.hediger@unibas.ch
Fabio Carbone, fabio.carbone@unibas.ch
About this study
Official title: 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.
- Conditions
- Depressive Symptoms, Human-Animal Interaction
- Being tested
- Oxytocin nasal spray, Animal-Assisted Intervention, Placebo
- Keywords
- Depressive Symptoms, Human-Animal Interaction, Animal-Assisted Interventions, Trust
- Medical subject headings
- Depression, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
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 InterventionOther
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.
PlaceboDrug
The placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: Oxytocin + dog present | Experimental | Not described Receives: Drug: Oxytocin nasal spray; Other: Animal-Assisted Intervention |
| Condition 2: Oxytocin + no dog present | Experimental | Not described Receives: Drug: Oxytocin nasal spray |
| Condition 3: Placebo + dog present | Experimental | Not described Receives: Other: Animal-Assisted Intervention; Drug: Placebo |
| Condition 4: Placebo + no dog present | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start29 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Karin Hediger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Karin Hediger, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248710
- Sponsor's protocol ID
- 2023-00523
- Other IDs
- 2023
- Acronym
- DOT
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are planning on sharing the anonymized data on a openly assess platform.
Publications
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.
PubMed 28968183Bakermans-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.
PubMed 23695233Feldman 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.
PubMed 17958710Kosfeld 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.
PubMed 15931222Nagasawa 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.
PubMed 25883356Powell, 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.
PubMed 31888759Coleman, 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 at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Oxytocin on Trust Towards Therapists and Dogs: A Randomized Controlled Trial in Healthy Adults
- ClinicalTrials.gov ID
- NCT06248710
- Acronym / sponsor ID
- DOT / 2023-00523
- Conditions
- Depressive Symptoms, Human-Animal Interaction
- Keywords
- Depressive Symptoms, Human-Animal Interaction, Animal-Assisted Interventions, Trust
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Dr. Karin HedigerUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal spraySyntocinon 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 | Drug | Condition 1: Oxytocin + dog present, Condition 2: Oxytocin + no dog present |
| Animal-Assisted InterventionThe 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. | Other | Condition 1: Oxytocin + dog present, Condition 3: Placebo + dog present |
| PlaceboThe placebo nose spray contains a saltwater solution and will be applied like the Syntocinon nose spray containing oxytocin. | Drug | Condition 3: Placebo + dog present, Condition 4: Placebo + no dog present |
Primary outcome
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.
9 secondary outcomes
Trust in the dog
Time frame: immediately after the intervention
perceived emotional closeness to the dog
Time frame: immediately after the intervention
perceived stress
Time frame: pre-intervention
perceived stress
Time frame: immediately after the intervention
level of difficulty
Time frame: immediately after the intervention
therapeutic alliance
Time frame: immediately after the intervention
therapeutic climate
Time frame: immediately after the intervention
psychological flexibility
Time frame: pre-intervention
psychological flexibility
Time frame: immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 28968183Algoe 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.
- Background: PubMed 23695233Bakermans-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.
- Background: PubMed 17958710Feldman 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.
- Background: PubMed 15931222Kosfeld 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.
- Background: PubMed 25883356Nagasawa 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.
- BackgroundPowell, 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: PubMed 31888759Crits-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.
- BackgroundColeman, 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.
- BackgroundGloster, 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
- Individual participant dataSharing planned: Undecided. We are planning on sharing the anonymized data on a openly assess platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxytocin nasal spray and Animal-Assisted Intervention in people with Depressive Symptoms and Human-Animal Interaction, run by Dr. Karin Hediger at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Hediger, Prof. Dr. (+41 (0)61 207 65 80, elena.pauli@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trust in the therapist (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06248710, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.