Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

MacDonald, Kai, M.D.18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Behavior Anxiety

Interventions

Placebo then intranasal oxytocinDRUG

Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.

Intranasal oxytocin then placeboDRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Kai MacDonald, MD 3368 2nd Ave Ste B

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: videotapes of session were reviewed and scored 1-3 months after the patient completes the study

Secondary Outcomes

Salivary Cortisol

Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.

Time frame: before drug, before session, and 20 minutes after session

Heart Rate Variability (HRV)

HRV will be measured before, during and after the therapy session.

Time frame: 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.

Time frame: measured before drug, immediately before session, and after the session

Data from ClinicalTrials.gov

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