Clinical trial NCT02730806: Treatment of NLP Method in Women Who Have Experienced Postpartum Post Traumatic Stress Dissorder
Official title: NLP Treatment for Women Who Experience Post Trauma Due to Traumatic Birth Child (PPPTSD) Mix Method Multiple Case Study))
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Traumatic Stress Disorders
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2016-04-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Women
2. Age: 18-40
3. 2 years from the date of birth;
4. PTSD or PTSD symptoms (indicating partial PTSD) diagnosed as a leading problem in the participant's life
5. Hebrew speaking
6. Insured by Maccabi Health Services

Exclusion Criteria:

1. Presence of one of the following:

   (A) Mental retardation; (B) Schizophrenia or other mental illnesses;
2. Changes in medication dose during the study or during the three prior months;
3. Suicide attempts or self-harm;
4. Alcohol or drug use;
5. Postpartum depression;
6. Incompetent
7. Stillbirth

Primary outcomes:
measure: PTSD (PCL-C) - PTSD checklist - measures the change in the overall level of PTSD
timeFrame: Through study completion, an average of 1 year
measure: 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
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Functioning Questionnaire - measures the change in overall subjects' Functioning Level
timeFrame: Through study completion, an average of 1 year1
measure: Post Traumatic Growth Inventory (PTGI) - measures the change in the overall level of PTG
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Rishon Le'Zion
country: Israel
facility: Mental Health Clinic
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Judith Reidman-Helfer, PhD
role: PRINCIPAL_INVESTIGATOR
References: