Treatment of NLP Method in Women Who Have Experienced Postpartum Post Traumatic Stress Dissorder (NLP)
Primary Purpose
Post-Traumatic Stress Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NLP
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorders
Eligibility Criteria
Inclusion Criteria:
- Women
- Age: 18-40
- 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
Exclusion Criteria:
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
Sites / Locations
- Mental Health Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NLP PTSD intervention protocol
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Functioning Questionnaire - measures the change in overall subjects' Functioning Level
This questionnaire, developed by Gelkopf et al 2011, will be conducted before and after the intervention.The questionnaire evaluates 6 functioning aspects in the passing month: occupation, studies, parenting, relationship with the spouse, being part of the community, friendship and intimacy. The answers are based on the Leickert scale with 5 degrees ranging from 0 ("very bad") to 4 ("very good"). The internal consistency is α = 0.86 (range 0-4, SD=0.79, M=3.20).
Post Traumatic Growth Inventory (PTGI) - measures the change in the overall level of PTG
This questionnaire, developed by Tedeschi & Calhoun, 1996, will be conducted before and after the intervention. It includes 22 items divided to 5 sub-scales: connection with others, new opportunites, personal strength, spiritual change and life appreciation. The subjects are asked to rate their answer concerning the amount of change they experienced in their life due to the traumatic event. The answers are based on the Leickert scale with 5 degrees ranging from 0 ("not at all") to 4 ("very much"). The internal consistency is α = 0.96.
Full Information
NCT ID
NCT02730806
First Posted
March 22, 2016
Last Updated
August 4, 2019
Sponsor
Yfat Weinstein-Zohar
Collaborators
Maccabi Healthcare Services, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02730806
Brief Title
Treatment of NLP Method in Women Who Have Experienced Postpartum Post Traumatic Stress Dissorder
Acronym
NLP
Official Title
NLP Treatment for Women Who Experience Post Trauma Due to Traumatic Birth Child (PPPTSD) Mix Method Multiple Case Study))
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yfat Weinstein-Zohar
Collaborators
Maccabi Healthcare Services, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NLP PTSD intervention protocol
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
NLP
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD (PCL-C) - PTSD checklist - measures the change in the overall level of PTSD
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
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
Description
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).
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Functioning Questionnaire - measures the change in overall subjects' Functioning Level
Description
This questionnaire, developed by Gelkopf et al 2011, will be conducted before and after the intervention.The questionnaire evaluates 6 functioning aspects in the passing month: occupation, studies, parenting, relationship with the spouse, being part of the community, friendship and intimacy. The answers are based on the Leickert scale with 5 degrees ranging from 0 ("very bad") to 4 ("very good"). The internal consistency is α = 0.86 (range 0-4, SD=0.79, M=3.20).
Time Frame
Through study completion, an average of 1 year1
Title
Post Traumatic Growth Inventory (PTGI) - measures the change in the overall level of PTG
Description
This questionnaire, developed by Tedeschi & Calhoun, 1996, will be conducted before and after the intervention. It includes 22 items divided to 5 sub-scales: connection with others, new opportunites, personal strength, spiritual change and life appreciation. The subjects are asked to rate their answer concerning the amount of change they experienced in their life due to the traumatic event. The answers are based on the Leickert scale with 5 degrees ranging from 0 ("not at all") to 4 ("very much"). The internal consistency is α = 0.96.
Time Frame
Through study completion, an average of 1 year.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women
Age: 18-40
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Reidman-Helfer, PhD
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Clinic
City
Rishon Le'Zion
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of NLP Method in Women Who Have Experienced Postpartum Post Traumatic Stress Dissorder
We'll reach out to this number within 24 hrs