Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting (OT-PT)
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 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|
- 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.
- 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.
|Study Start Date:||December 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: active drug
Drug: intranasal oxytocin
single dose of 40 IU intranasal oxytocin or similar volume of placeboDrug: placebo
single dose of 40 IU intranasal oxytocin or similar volume of placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081249
|United States, California|
|Kai MacDonald, MD 3368 2nd Ave Ste B|
|San Diego, California, United States, 92103|