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Completed

NCT Number: NCT01081249

Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

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.

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Key information

Conditions

Behavior Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Kai MacDonald, MD 3368 2nd Ave Ste B

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo then intranasal oxytocin

Drug

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

Drug

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.

Primary outcomes

  1. Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug

    Time frame: 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 outcomes

  1. Salivary Cortisol

    Time frame: 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.

  2. Heart Rate Variability (HRV)

    Time frame: continuously monitored from time before drug delivery to 20 minutes after session

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

  3. Subjective Ratings of Anxiety and Trust of the Therapist

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

MacDonald, Kai, M.D.

Indiv

Registry information

Official study title

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

Acronym: OT-PT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2010
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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