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Post-Traumatic Stress DisordersNLPNCT02730806

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

A study testing NLP in people with Post-Traumatic Stress Disorders, run by Yfat Weinstein-Zohar at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Post-Traumatic Stress Disorders
What is being tested?
NLP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIsrael
Study dates
27 Feb 2017to 20 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Presence of one of the following:
  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Mental Health Clinic

    Rishon Le'Zion

Other trials in Israel

About this study

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

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.

Read the 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.

Being tested
NLP
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NLPBehavioural

    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.

Study groups in NCT02730806
Study groupRoleWhat they receive
NLP PTSD intervention protocolExperimentalBehavioral 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
Receives: Behavioral: NLP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 1 year

  2. 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).

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)

  1. 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).

    Measured: Through study completion, an average of 1 year1

  2. 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.

    Measured: Through study completion, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2016 (estimated)
  2. Study start27 Feb 2017
  3. Primary completion14 Dec 2018
  4. Study completion20 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730806
Sponsor's protocol ID
WEINNLPCTIL
Acronym
NLP
Status last verified
Aug 2019
First submitted
22 Mar 2016
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NLP in people with Post-Traumatic Stress Disorders, run by Yfat Weinstein-Zohar at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD (PCL-C) - PTSD checklist - measures the change in the overall level of PTSD (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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