NCT05432089

The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization

Recruiting now Phase 2 Last updated 28 June 2024

What this trial tests

Phase 2 trial testing Intranasal Oxytocin in Severe Mental Illness in 120 participants. Currently enrolling.

Timeline

30 March 2023

Primary endpoint
1 July 2026

1 July 2026

Quick facts

Lead sponsor	Shalvata Mental Health Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	30 March 2023
Primary completion	1 July 2026
Estimated completion	1 July 2026
Sites	1 location across Israel

Drugs / interventions tested

• Intranasal Oxytocin — full drug profile →

Conditions studied

• Severe Mental Illness — all drugs for Severe Mental Illness →

Sponsor

Shalvata Mental Health Center — full company profile →

Who can join

Adults 18 to 80, any sex, with Severe Mental Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Oxytocin (OT) is a nine-amino acid neuropeptide, known to have a fundamental role in social communication. In a recent randomized, double-blind, placebo-controlled study carried out in Shalvata Mental Health Center, OT was administrated to patients suffering from severe mental health illness. The results indicated that OT has a clear beneficial effect on therapeutic outcomes. However, to our knowledge, the effect of OT administration to both patients and therapists on the therapeutic process was never tested. Substance administration to caregivers is therefore possible, and could, in some cases, provide further knowledge about the caregiving dynamics. Since we know the therapist's characteristics effect the therapeutic alliance and that OT is associated with the therapeutic alliance, patient-therapist bond, and therapy outcome, we are led to ask if OT administration to patients and therapists could allow for a deeper understanding of OT's effects on the therapeutic process.

Another variable found to be associated with the therapeutic process is Physiological Synchronization. Physiological Synchronization (PS) is a primarily interpersonal phenomenon which includes coordination of physiological signals between two or more interacting individuals. Despite the rising number of studies examining PS, its physiological and psychological mechanisms are yet to be fully understood. Based on literature indicating associations between OT and PS, and associations each of them has with the therapeutic process and its facilitators, in this study we wish to examine the influence of OT on PS through intranasal OT administration to patients alone and to patients and therapists together.

Research Hypotheses:

1. Patients receiving OT will demonstrate higher levels of PS during the measured session compared to patients receiving placebo.
2. Patients receiving OT will report higher levels of perceived therapist empathy as compared to patients receiving placebo.
3. These associations will be stronger when both patient and therapist receive OT in comparison to patient alone.
4. Changed in PS and empathy will be associated with OT even after controlling for patient rated alliance and session impact.
5. These findings will sustain after controlling for severity of symptoms and attachment patterns.

Method:

Participants. Sixty patients and their therapists will be recruited for the pilot study. Patients will be recruited from the inpatient adult psychiatric wards at Shalvata Mental Health Center. Therapists in this study will be comprised of psychologists, psychiatrists, and social workers, in different stages of seniority and training.

Instruments. Attachment patterns, symptom severity, side effects and therapeutic process measurements - working alliance, perceived empathy and session impact - will be assessed using self-report questionnaires. PS will be measured by recordings of the electrodermal activity (EDA) measured by skin conductance signals, using a galvanic skin response (GSR) device. Oxytocin Administration will be performed intranasally using a spray containing 24U.

Procedure. Sixty patients meeting inclusion criteria and their therapists will be recruited for the pilot study. Dyads will be randomized and double-blindly allocated to receive intra-nasal oxytocin or placebo. Dyads will be followed for two consecutive sessions, approximately at their fourth and fifth sessions. After signing informed consent forms, patients and therapists will complete therapeutic process measurements, and patients will be assessed for the severity of their symptoms and attachment patterns. Prior to the first session, patients will be administrated with either IN-OT or PLC and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists, and patients will complete a side-effect questionnaire. Prior to the second session, both patients and therapists will receive either IN-OT or PLC (each dyad will receive the same substance) and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will then be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists alongside with a side-effect questionnaire.

The uniqueness of the proposed study is rooted in the view of the psychotherapy dyad as undetached, by focusing on the dyad and not on the patient alone. Focusing on patient-therapist synchronization lies on the understanding of the patient-therapist bond as co-dependent and co-affected. Such research could increase our understanding of PS between patient and therapist and its meaning in psychotherapy research and practice.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Nasal-Brain Drug Delivery Route: Mechanisms and Applications to Central Nervous System Diseases.
   Qiu Y, Huang S, Peng L, Yang L, et al · · 2025 · cited 18× · PMID 40487748 · DOI 10.1002/mco2.70213