跳至主要内容
临床试验/NCT02730806
NCT02730806Unknown不适用

NLP Treatment for Women Who Experience Post Trauma Due to Traumatic Birth Child (PPPTSD) Mix Method Multiple Case Study))

Yfat Weinstein-Zohar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
PTSD (PCL-C) - PTSD checklist - measures the change in the overall level of PTSD

研究概览

简要总结

The purpose of this interventional study is to evaluate the effectiveness of the NLP PTSD protocol in the event of PPPTSD. The study's main hypothesis is that the implementation of the NLP protocol will be effective and result in reduction of the overall PTSD level.

详细描述

Post Traumatic Stress Disorder (PTSD) is considered to be a major Public Health disorder in the Western world with 8% prevalence. When including partial/Sub-clinic PTSD, prevalence rises dramatically. Studies examining the common intervention methods indicate certain clinical effectiveness although none presents sweeping efficiency. Therefore, this syndrome is still a significant clinical problem in Public Health.

This study focuses on women population who have experienced trauma in childbirth. Such women experience full post traumatic symptoms (Full PTSD) or Partial/Subclinical PTSD. This syndrome is defined in professional literature as PPPTSD (Post-Partum Post Traumatic Stress Disorder). While childbirth is a healthy part of the cycle of life, birth itself is an event that may involve a risk to the mother and child life. PPPTSD prevalence ranges between 1%-6% and is expressed in at least two of the criteria listed in the DSM. 8.3%-28% of women suffer from partial PPPTSD.

Neuro Linguistic Programming (NLP) is a "one-on-one" intervention method, connecting Neurological processes (N), Linguistic (L) and learned behaviors (P), in order to allow conceptual/perceptual, mental and behavioral changes. Even though NLP is used since the 1970's and field testimonies report its effectiveness, there are only few studies regarding its effectiveness in the field of PTSD.

This study's main objective is to examine the effectiveness of the NLP PTSD protocol.

The study population will include approx 30 women, up to 2 years after birth, with PPPTSD. The women will be treated in 5 individual sessions implementing the NLP PTSD protocol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 2 years from the date of birth;
  • PTSD or PTSD symptoms (indicating partial PTSD) diagnosed as a leading problem in the participant's life
  • Hebrew speaking
  • Insured by Maccabi Health Services

排除标准

  • Presence of one of the following:
  • (A) Mental retardation; (B) Schizophrenia or other mental illnesses;
  • Changes in medication dose during the study or during the three prior months;
  • Suicide attempts or self-harm;
  • Alcohol or drug use;
  • Postpartum depression;
  • Incompetent

研究组 & 干预措施

NLP PTSD intervention protocol

Experimental

Behavioral intervention (NLP) - intervention method will be 5 weekly personal therapy and counseling sessions with a certified therapist specializing in NLP, implementing the NLP PTSD protocol, such as Visual Kinesthetic Dissociation (VKD) behavioral technique for PPPTSD cases

干预措施: NLP (Behavioral)

结局指标

主要结局

PTSD (PCL-C) - PTSD checklist - measures the change in the overall level of PTSD

时间窗: Through study completion, an average of 1 year

A Self-report questionnaire diagnoses the severity of PTSD (PCL-C), conducted before and after the intervention, enables to examine the overall level of PTSD (PTSD volume). Developed by Weathers et al, 1993, based on criteria appearing in DSM- V, it includes 20 questions, with each item testing the presence and the severity of one of the symptoms of PTSD during the passing month. Answers are based on the Leickert scale with 5 degrees ranging from 0 ("never") to 4 ("very much"). Overall measurement ranges from 0 to 80 (PTS - Post Traumatic Symptoms). Cut mark for the estimation of PTSD \>= 44.

PTSD (PCL-C) - PTSD checklist - measures also the change in the levels of PTSD symptoms: intrusion/re-experiencing, avoidance, arousal and negative alterations in cognitions and mood

时间窗: Through study completion, an average of 1 year

A Self-report questionnaire diagnoses the severity of PTSD (PCL-C), conducted before and after the intervention, enables to examine also the levels of PTSD symptoms: intrusion/re-experiencing avoidance, arousal and negative alterations in cognitions and mood. Developed by Weathers et al, 1993, based on criteria appearing in DSM- V, it includes 20 questions, with each item testing the presence and the severity of one of the symptoms of PTSD during the passing month. Questions are presented in four groups, which express the four main symptom clusters in PTSD: intrusion/re-experiencing (items 1-5) (criteria B), avoidance (items 6-7) (criteria C), negative alterations in cognitions and mood (items 8-14) (criteria D), and hyper-arousal (items 15-20) (criteria E).

次要结局

  • Functioning Questionnaire - measures the change in overall subjects' Functioning Level(Through study completion, an average of 1 year1)
  • Post Traumatic Growth Inventory (PTGI) - measures the change in the overall level of PTG(Through study completion, an average of 1 year.)

研究者

发起方
Yfat Weinstein-Zohar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yfat Weinstein-Zohar

PhD student

Assuta Hospital Systems

研究点 (1)

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