Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

Phase 4

Completed

• Conditions: Anxiety; Behavior
• Interventions: Drug: Placebo then intranasal oxytocin; Drug: Intranasal oxytocin then placebo

• Registration Number: NCT01081249
• Lead Sponsor: MacDonald, Kai, M.D.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2014-09-16
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-13
• Last Update Submitted: 2014-10-13
• Results First Posted: 2014-10-16
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo then Oxytocin	Placebo then intranasal oxytocin	Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.
Oxytocin then placebo	Intranasal oxytocin then placebo	Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Primary Outcome Measures

Name	Time	Method
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug	videotapes of session were reviewed and scored 1-3 months after the patient completes the study	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.

Secondary Outcome Measures

Name	Time	Method
Salivary Cortisol	before drug, before session, and 20 minutes after session	Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.
Heart Rate Variability (HRV)	continuously monitored from time before drug delivery to 20 minutes after session	HRV will be measured before, during and after the therapy session.
Subjective Ratings of Anxiety and Trust of the Therapist	measured before drug, immediately before session, and after the session	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.

Trial Locations

Locations (1)

Kai MacDonald, MD 3368 2nd Ave Ste B; 🇺🇸 San Diego, California, United States