Comparison of Ericksonian Hypnotherapy and CBT in PTSD: A Clinical Trial
NEPTUNE
Neuropsychophysiological Comparison of Ericksonian Hypnotherapy and Cognitive Behavioral Therapy in Patients Diagnosed With Post-Traumatic Stress Disorder: A Protocol and Pilot Study of Two Armed Open Label Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Brief Summary (Plain Language) The goal of this clinical trial is to compare the effects of Ericksonian Hypnotherapy and Cognitive Behavioral Therapy (CBT) on people diagnosed with Post-Traumatic Stress Disorder (PTSD). The study will also evaluate how these therapies impact brain activity, skin conductance, and heart rate. The main questions it aims to answer are: Does Ericksonian Hypnotherapy reduce PTSD symptoms as effectively as CBT? Do these therapies affect brain activity, skin conductance, and heart rate differently? Participants will be randomly assigned to one of two therapy groups: Ericksonian Hypnotherapy Group: Weekly 50-minute sessions for 12 weeks. CBT Group: Weekly 50-minute sessions for 12 weeks. To assess physiological and emotional responses, researchers will measure brain activity (EEG), skin conductance (GSR), and heart rate (HR) at various points. These assessments include a guided discussion task where participants reflect on their trauma in a controlled therapeutic environment. This task allows researchers to evaluate emotional regulation and stress markers in real time. This study aims to provide insight into the physiological and psychological impacts of both therapies on PTSD treatment, offering a deeper understanding of how these interventions influence neurophysiological stress responses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2024
CompletedFirst Submitted
Initial submission to the registry
January 1, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2025
CompletedJune 5, 2025
June 1, 2025
4 months
January 1, 2025
June 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in PTSD Symptom Severity
Change in PTSD symptom severity, measured by the PTSD Checklist for DSM-5 (PCL-5). Scores will assess the frequency and intensity of PTSD symptoms.
Baseline and Week 12
Secondary Outcomes (4)
Changes in Brain Activity (EEG)
Baseline and Week 12
Changes in Heart Rate (HR)
Baseline and Week 12
Reduction in Anxiety Symptoms
Baseline and Week 12
Reduction in Depression Symptoms
Baseline and Week 12
Study Arms (3)
Ericksonian Hypnotherapy (EH) Arm
EXPERIMENTALParticipants will receive 12 weekly sessions of 50 minutes each, focusing on tailored hypnotic suggestions and subconscious communication techniques specifically designed to address PTSD symptoms.
Cognitive Behavioral Therapy (CBT) Arm
ACTIVE COMPARATORParticipants will receive 12 weekly sessions of 50 minutes each, utilizing cognitive restructuring, exposure exercises, and behavioral interventions to reduce PTSD symptoms.
Control Group
NO INTERVENTIONParticipants in the control group will not receive any therapeutic intervention. They will undergo baseline and post-study assessments using neuropsychophysiological measures (EEG, GSR, HR) and psychological scales (PCL-5, BDI-II, BAI) to monitor changes over time without active treatment.
Interventions
Participants in this group will receive 12 weekly sessions of 50 minutes each. The therapy will focus on tailored hypnotic suggestions, subconscious communication techniques, and trauma-focused interventions specifically designed to address PTSD symptoms. Sessions will be conducted by a certified hypnotherapist under clinical supervision.
Participants in this group will receive 12 weekly sessions of 50 minutes each. The therapy will utilize cognitive restructuring techniques, exposure exercises, and behavioral interventions aimed at reducing PTSD symptoms. Sessions will be led by a licensed psychotherapist trained in trauma-focused CBT.
Eligibility Criteria
You may qualify if:
- Adults aged 18-60 years. Diagnosed with Post-Traumatic Stress Disorder (PTSD) based on DSM-5 criteria. No current psychiatric medication usage. Not undergoing any other psychotherapeutic intervention during the study period.
- Ability to attend all therapy sessions and assessments. Ability to provide written informed consent. No neurological disorders or cognitive impairments that could affect participation.
You may not qualify if:
- Individuals under 18 or over 60 years of age. Current or past diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric disorders.
- Acute risk of harm from engaging in trauma discussions. Use of psychiatric medication within the last 3 months. Ongoing participation in other psychotherapeutic interventions. History of substance abuse or dependence in the past 12 months. Known neurological disorders (e.g., epilepsy, traumatic brain injury). Inability to provide informed consent or comply with study procedures. Pregnancy or breastfeeding. Severe cardiovascular conditions that might interfere with physiological assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Üsküdar University
Istanbul, Istanbul, 34277, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selami Varol Ülker, Phd
Üsküdar University
- PRINCIPAL INVESTIGATOR
Metin Çınaroğlu, Phd
Istanbul Nisantasi University
- PRINCIPAL INVESTIGATOR
Eda Yılmazer, Phd
Beykoz University
- STUDY CHAIR
Gökben Hızlı Sayar, Prof
Üsküdar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
January 1, 2025
First Posted
January 7, 2025
Study Start
November 15, 2024
Primary Completion
March 15, 2025
Study Completion
April 15, 2025
Last Updated
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data will become available after publication of the primary results in an SSCI-indexed journal and will remain accessible for 5 years.
- Access Criteria
- Data will be made available to qualified researchers upon submission of a methodologically sound proposal and approval by the principal investigator.
Individual participant data (IPD) that underlie the results reported in this study will be shared, after de-identification, to ensure participant confidentiality. This includes neuropsychophysiological data (EEG, GSR, HR), psychological assessment scores (PCL-5, BDI-II, BAI), and sociodemographic information relevant to the study's objectives.