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

NCT05432089 | Recruiting Phase 2

• 1 other identifier: 0002-22-SHA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe Mental Illness

Keywords

Oxytocin; Physiological Synchronization; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• skin conductance synchrony

  as measured by GSR devices during sessions

  1-2 weeks including 2 consecutive psychotherapy sessions

Secondary Outcomes (3)

• working alliance

  1-2 weeks including 3 measurements: baseline, post-session 1 and post-session 2.

• perceived empathic understanding

  1-2 weeks including 3 measurements: baseline, post-session 1 and post-session 2.

• session impact

  1-2 weeks including 2 measurements: post-session 1 and post-session 2.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: Intranasal Oxytocin

Placebo Group

PLACEBO COMPARATOR

Drug: Intranasal Oxytocin

Interventions

Intranasal Oxytocin DRUG

24IU (12IU\*2) of OT, Sorbitol, Benzyl, alcohol glycerol, distilled water.

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age above 18.
• any type of psychiatric illness.
• hospitalization in one of the inpatients wards.

You may not qualify if:

• current severe psychotic episode
• pregnancy according to self-report.
• psychologists, psychiatrists, and social workers, in different stages of seniority and training.
• pregnancy according to self-report.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata Mental health Center

Hod HaSharon, Israel

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Omer Sedoff, MA

CONTACT

+97297478555; omerse@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: March 30, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

IL (1)