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Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting (OT-PT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kai MacDonald, MacDonald, Kai, M.D.
ClinicalTrials.gov Identifier:
NCT01081249
First received: March 3, 2010
Last updated: November 4, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Behavior
Anxiety
 Drug: intranasal oxytocin
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
Drug Information available for: Oxytocin
U.S. FDA Resources

Further study details as provided by MacDonald, Kai, M.D.:

Primary Outcome Measures:
  • Verbal and nonverbal behavior in therapy session [ Time Frame: videotapes of session will be reviewed and scored 1-3 months after the patient completes the study ] [ Designated as safety issue: No ]
    Videotapes of 2 therapy session (PBO/OT) will be reviewed by blinded raters to determine differences in two treatments.


Secondary Outcome Measures:
  • salivary cortisol [ Time Frame: before drug, before session, and 20 minutes after session ] [ Designated as safety issue: No ]
    Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.

  • heart rate variability (HRV) [ Time Frame: continuously monitored from time before drug delivery to 20 minutes after session ] [ Designated as safety issue: No ]
    HRV will be measured before, during and after the therapy session.

  • subjective ratings of anxiety and trust of the therapist [ Time Frame: measured before drug, immediately before session, and after the session ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: December 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: active drug
placebo
 Drug: intranasal oxytocin
single dose of 40 IU intranasal oxytocin or similar volume of placebo
Drug: placebo
single dose of 40 IU intranasal oxytocin or similar volume of placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081249

Locations
United States, California
Kai MacDonald, MD 3368 2nd Ave Ste B
San Diego, California, United States, 92103
Sponsors and Collaborators
MacDonald, Kai, M.D.
  More Information

Publications:

Responsible Party: Kai MacDonald, Assistant clinical professor, MacDonald, Kai, M.D.
ClinicalTrials.gov Identifier: NCT01081249     History of Changes
Other Study ID Numbers: UCSD IRB 080953
Study First Received: March 3, 2010
Last Updated: November 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MacDonald, Kai, M.D.:
psychotherapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Oxytocin
Oxytocics
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013