Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting (OT-PT)
2014年10月13日 更新者：Kai MacDonald、MacDonald, Kai, M.D.
Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study
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.
研究概览
研究类型
介入性
注册 (实际的)
18
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
San Diego、California、美国、92103
- Kai MacDonald, MD 3368 2nd Ave Ste B
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Placebo then Oxytocin
Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.
|
Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.
|
|
实验性的：Oxytocin then placebo
Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug
大体时间：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.
|
videotapes of session were reviewed and scored 1-3 months after the patient completes the study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Salivary Cortisol
大体时间：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.
|
before drug, before session, and 20 minutes after session
|
|
Heart Rate Variability (HRV)
大体时间：continuously monitored from time before drug delivery to 20 minutes after session
|
HRV will be measured before, during and after the therapy session.
|
continuously monitored from time before drug delivery to 20 minutes after session
|
|
Subjective Ratings of Anxiety and Trust of the Therapist
大体时间：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.
|
measured before drug, immediately before session, and after the session
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kai MacDonald, MD、UCSD
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry. 2010 Jan-Feb;18(1):1-21. doi: 10.3109/10673220903523615.
- MacDonald K, MacDonald TM, Brune M, Lamb K, Wilson MP, Golshan S, Feifel D. Oxytocin and psychotherapy: a pilot study of its physiological, behavioral and subjective effects in males with depression. Psychoneuroendocrinology. 2013 Dec;38(12):2831-43. doi: 10.1016/j.psyneuen.2013.05.014. Epub 2013 Jun 28.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年12月1日
初级完成 (实际的)
2012年7月1日
研究完成 (实际的)
2012年7月1日
研究注册日期
首次提交
2010年3月3日
首先提交符合 QC 标准的
2010年3月4日
首次发布 (估计)
2010年3月5日
研究记录更新
最后更新发布 (估计)
2014年10月16日
上次提交的符合 QC 标准的更新
2014年10月13日
最后验证
2014年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.