Title

Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting
Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    oxytocin ...
  • Study Participants

    18
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 Started
Dec 31
2008
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Results Posted
Oct 16
2014
Estimate
Last Update
Oct 16
2014
Estimate

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.

Drug 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.

Placebo then Oxytocin Experimental

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Oxytocin then placebo Experimental

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Criteria

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

Summary

Placebo Then Oxytocin

Oxytocin Then Placebo

All Events

Event Type Organ System Event Term

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.

Placebo

ECSI affiliation

45.4
Number of behaviors exhibited (Mean)
Standard Deviation: 5.1

ECSI assertion

30.5
Number of behaviors exhibited (Mean)
Standard Deviation: 5.7

ECSI displacement

46.6
Number of behaviors exhibited (Mean)
Standard Deviation: 3.9

ECSI eye contact

34.0
Number of behaviors exhibited (Mean)
Standard Deviation: 2.2

ECSI flight

65.7
Number of behaviors exhibited (Mean)
Standard Deviation: 2.9

ECSI gesture

28.8
Number of behaviors exhibited (Mean)
Standard Deviation: 3.0

ECSI prosocial

69.8
Number of behaviors exhibited (Mean)
Standard Deviation: 7.3

ECSI relaxation

19.4
Number of behaviors exhibited (Mean)
Standard Deviation: 4.4

ECSI submission

24.4
Number of behaviors exhibited (Mean)
Standard Deviation: 6.1

Active Drug

ECSI affiliation

46.0
Number of behaviors exhibited (Mean)
Standard Deviation: 4.5

ECSI assertion

26.6
Number of behaviors exhibited (Mean)
Standard Deviation: 3.9

ECSI displacement

41.6
Number of behaviors exhibited (Mean)
Standard Deviation: 5.2

ECSI eye contact

34.8
Number of behaviors exhibited (Mean)
Standard Deviation: 2.4

ECSI flight

61.1
Number of behaviors exhibited (Mean)
Standard Deviation: 4.0

ECSI gesture

29.3
Number of behaviors exhibited (Mean)
Standard Deviation: 2.2

ECSI prosocial

71.1
Number of behaviors exhibited (Mean)
Standard Deviation: 7.3

ECSI relaxation

18.7
Number of behaviors exhibited (Mean)
Standard Deviation: 3.3

ECSI submission

25.14
Number of behaviors exhibited (Mean)
Standard Deviation: 5.6

Heart Rate Variability (HRV)

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

Outcome Measure Data Not Reported

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.

Outcome Measure Data Not Reported

Salivary Cortisol

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

Outcome Measure Data Not Reported

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Oxytocin Then Placebo

Placebo Then Oxytocin

Drop/Withdrawal Reasons

Placebo Then Oxytocin