Anxiety, Behavior
Conditions
Keywords
psychotherapy
Brief 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.
Interventions
DRUGPlacebo 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.
DRUGIntranasal 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.
Sponsors
MacDonald, Kai, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | 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
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol | 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. |
| Heart Rate Variability (HRV) | continuously monitored from time before drug delivery to 20 minutes after session | HRV will be measured before, during and after the therapy session. |
| Subjective Ratings of Anxiety and Trust of the Therapist | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Drug placebo
intranasal oxytocin: single dose of 40 IU intranasal oxytocin or similar volume of placebo
placebo: single dose of 40 IU intranasal oxytocin or similar volume of placebo | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Diagnosed with Bipolar Disorder | 0 | 1 |
Baseline characteristics
| Characteristic | Active Drug |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 11 |
| serious Total, serious adverse events | 0 / 6 | 0 / 11 |
Outcome results
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.
Time frame: videotapes of session were reviewed and scored 1-3 months after the patient completes the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI submission | 24.4 Number of behaviors exhibited | Standard Deviation 6.1 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI assertion | 30.5 Number of behaviors exhibited | Standard Deviation 5.7 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI eye contact | 34 Number of behaviors exhibited | Standard Deviation 2.2 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI displacement | 46.6 Number of behaviors exhibited | Standard Deviation 3.9 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI affiliation | 45.4 Number of behaviors exhibited | Standard Deviation 5.1 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI relaxation | 19.4 Number of behaviors exhibited | Standard Deviation 4.4 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI flight | 65.7 Number of behaviors exhibited | Standard Deviation 2.9 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI gesture | 28.8 Number of behaviors exhibited | Standard Deviation 3 |
| Placebo | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI prosocial | 69.8 Number of behaviors exhibited | Standard Deviation 7.3 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI gesture | 29.3 Number of behaviors exhibited | Standard Deviation 2.2 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI affiliation | 46.0 Number of behaviors exhibited | Standard Deviation 4.5 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI eye contact | 34.8 Number of behaviors exhibited | Standard Deviation 2.4 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI submission | 25.14 Number of behaviors exhibited | Standard Deviation 5.6 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI prosocial | 71.1 Number of behaviors exhibited | Standard Deviation 7.3 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI flight | 61.1 Number of behaviors exhibited | Standard Deviation 4 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI assertion | 26.6 Number of behaviors exhibited | Standard Deviation 3.9 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI displacement | 41.6 Number of behaviors exhibited | Standard Deviation 5.2 |
| Active Drug | Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug | ECSI relaxation | 18.7 Number of behaviors exhibited | Standard Deviation 3.3 |
Secondary
Heart Rate Variability (HRV)
HRV will be measured before, during and after the therapy session.
Time frame: continuously monitored from time before drug delivery to 20 minutes after session
Secondary
Salivary Cortisol
Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.
Time frame: before drug, before session, and 20 minutes after session
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.
Time frame: measured before drug, immediately before session, and after the session