Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

Study Overview
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Brief Summary
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Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped, and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive benefits on nonverbal behavior in the therapy session, as well as have positive effects on subjective anxiety, cortisol and heart rate.

Official Title
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Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study

Conditions
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Behavior, Anxiety

Intervention / Treatment
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* Drug: Placebo then intranasal oxytocin
* Drug: Intranasal oxytocin then placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: in current mental health treatment male 18-65 Exclusion Criteria: diagnosis of schizophrenia or psychosis diagnosis of autism or Aspergers disorder active substance use disorder at moderate or high risk of self-harm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo then Oxytocin<br>Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit. | Drug: Placebo then intranasal oxytocin<br>* Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.<br>|
| Experimental: Oxytocin then placebo<br>Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit. | Drug: Intranasal oxytocin then placebo<br>* Participant received a single dose of 40 IU intranasal oxytocin at the first psychotherapy session, and received a similar dose of intranasal placebo spray at the second session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | Videotapes of 2 therapy session (PBO/OT) were reviewed by blinded raters to determine differences in two treatments. There were nine aspects analyzed using the Ethological Coding System for Interviews: eye contact, affiliation, submission, prosocial, flight, assertion, displacement, relaxation, and gesture. | videotapes of session were reviewed and scored 1-3 months after the patient completes the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol | Salivary cortisol will be measured after the treatment, and before, during and after the therapy session. | before drug, before session, and 20 minutes after session | 
| Heart Rate Variability (HRV) | HRV will be measured before, during and after the therapy session. | continuously monitored from time before drug delivery to 20 minutes after session | 
| Subjective Ratings of Anxiety and Trust of the Therapist | Patient will fill out ratings of subjective anxiety (STAI), mood and energy (PANAS), and trust (Likert scale) in the therapist before and after the session. | measured before drug, immediately before session, and after the session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychotherapy