Treatment of NLP Method in Women Who Have Experienced Postpartum Post Traumatic Stress Dissorder

NCT02730806 | Unknown

• 1 other identifier: WEINNLPCTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorders

Outcome Measures

Primary Outcomes (2)

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

  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.

  Through study completion, an average of 1 year

• 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

  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).

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• 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.

Study Arms (1)

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

Behavioral: NLP

Interventions

NLP BEHAVIORAL

NLP techniques, such as VKD, visual/auditory/kinesthetic swishes, modified especially for PTSD, will be implemented one-on-one with each woman in this arm.

NLP PTSD intervention protocol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Age: 18-40
• 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

You may not qualify if:

• 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
• Stillbirth

Sponsors & Collaborators

• Yfat Weinstein-Zohar: lead
• Maccabi Healthcare Services, Israel: collaborator

Study Sites (1)

Mental Health Clinic

Rishon Le'Zion, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Judith Reidman-Helfer, PhD

  Maccabi Healthcare Services, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 7, 2016
• Study Start: February 27, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 20, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)