Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

Anxiety Clinical Trial

— OT-PT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081249
• Other study ID #: UCSD IRB 080953
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2010
• Last updated: October 13, 2014
• Start date: December 2008
• Est. completion date: July 2012

Study information

• Verified date: October 2014
• Source: MacDonald, Kai, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Behavior

Intervention

Drug:
• Placebo then intranasal oxytocin
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 placebo
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.

Locations

Country	Name	City	State
United States	Kai MacDonald, MD 3368 2nd Ave Ste B	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
MacDonald, Kai, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry. 2010 Jan-Feb;18(1):1-21. doi: 10.3109/10673220903523615. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No