Actively Recruiting
The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization: a Randomized Controlled Pilot Study
Led by Shalvata Mental Health Center · Updated on 2024-06-28
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the effects of intranasal oxytocin (OT), a neuropeptide important for social communication, on the therapeutic process between patients and therapists in adult psychiatric inpatient wards. The study will investigate how OT administration influences physiological synchronization (PS) between patients and therapists, perceived therapist empathy, and therapeutic alliance. The trial focuses on both patients and therapists receiving OT or placebo to better understand OT's role in therapy dynamics and outcomes. Participants will be randomized into groups receiving either intranasal oxytocin or placebo. Sixty patient-therapist dyads will take part, with patients receiving OT or placebo before two consecutive psychotherapy sessions (around their fourth and fifth sessions). The first session involves OT or placebo administered to patients only, while the second session involves both patients and therapists receiving the same substance. Skin conductance synchrony will be recorded during sessions to measure PS, and therapeutic process questionnaires will be completed by both patients and therapists after each session. Participants will complete self-report questionnaires assessing attachment patterns, symptoms, therapeutic alliance, empathy, and session impact. Electrodermal activity (EDA) will be measured using a galvanic skin response device during sessions to assess physiological synchronization. Side effects of OT will be monitored through questionnaires. The main outcome is skin conductance synchrony across two sessions. Secondary outcomes include working alliance, perceived empathy, and session impact measured before and after therapy sessions. The study duration covers approximately 1-2 weeks for these measurements and sessions.
CONDITIONS
Brief Title
The Effects of Oxytocin Administration to Patients and Therapists on Physiological Synchronization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged above 18 years
- Patients with any type of psychiatric illness
- Patients currently hospitalized in inpatient psychiatric wards
- Therapists who are psychologists, psychiatrists, or social workers at various training levels
You will not qualify if you...
- Patients currently experiencing a severe psychotic episode
- Patients who are pregnant (self-reported)
- Therapists who are pregnant (self-reported)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must meet age, psychiatric illness, and hospitalization criteria; exclusion applies for severe psychotic episodes and pregnancy.
Duration - 1 to 2 weeks including 2 consecutive psychotherapy sessions
Participants receive intranasal oxytocin or placebo before two consecutive psychotherapy sessions to assess effects on physiological synchronization and therapeutic process.
2 in-person sessions with administration of study drug or placebo prior to each session
Trial Site Locations
Total: 1 location
1
Shalvata Mental health Center
Hod HaSharon, Israel
Actively Recruiting
Research Team
O
Omer Sedoff, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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