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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Post-Traumatic Stress Disorders
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: NLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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.
- First posted7 Apr 2016 (estimated)
- Study start27 Feb 2017
- Primary completion14 Dec 2018
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yfat Weinstein-Zohar
- Sponsor type
- University, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor-investigator, Yfat Weinstein-Zohar, Assuta Hospital Systems
- Investigators
- Judith Reidman-Helfer, PhD, Principal investigator, Maccabi Healthcare Services, Israel
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NLP Treatment for Women Who Experience Post Trauma Due to Traumatic Birth Child (PPPTSD) Mix Method Multiple Case Study))
- ClinicalTrials.gov ID
- NCT02730806
- Acronym / sponsor ID
- NLP / WEINNLPCTIL
- Conditions
- Post-Traumatic Stress Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yfat Weinstein-ZoharUniversity, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NLP PTSD intervention protocol | Experimental | Behavioral: NLPBehavioral 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Presence of one of the following:
- Changes in medication dose during the study or during the three prior months;
- Suicide attempts or self-harm;
- Alcohol or drug use;
- Postpartum depression;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NLPNLP techniques, such as VKD, visual/auditory/kinesthetic swishes, modified especially for PTSD, will be implemented one-on-one with each woman in this arm. | Behavioural | NLP PTSD intervention protocol |
Primary outcome
PTSD (PCL-C) - PTSD checklist - measures the change in the overall level of PTSD
Time frame: 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
Time frame: 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).
2 secondary outcomes
Functioning Questionnaire - measures the change in overall subjects' Functioning Level
Time frame: Through study completion, an average of 1 year1
Post Traumatic Growth Inventory (PTGI) - measures the change in the overall level of PTG
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Reidman-Helfer, PhD principal investigator
Maccabi Healthcare Services, Israel
1 site in 1 country: see every site and its status.
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?
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.