Üsküdar University
Istanbul, 34277, Turkey (Türkiye)
NCT Number: NCT06761716
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Istanbul, 34277, Turkey (Türkiye)
Study Description This clinical trial aims to compare the neuropsychophysiological effects of Ericksonian Hypnotherapy (EH) and Cognitive Behavioral Therapy (CBT) in individuals diagnosed with Post-Traumatic Stress Disorder (PTSD). Additionally, a control group will be included to observe natural changes without therapeutic intervention.
PTSD is a debilitating psychological condition triggered by exposure to traumatic events, characterized by symptoms such as intrusive thoughts, hyperarousal, avoidance behaviors, and negative mood states. Both CBT and EH have shown promise in alleviating PTSD symptoms, yet their comparative neuropsychophysiological impacts remain underexplored.
Study Design Participants: Individuals aged 18-60 diagnosed with PTSD.
Randomization: Participants will be randomly assigned to one of three groups:
Ericksonian Hypnotherapy Group (EH): 12 weekly sessions of 50 minutes each, focusing on subconscious communication, personalized hypnotic suggestions, and trauma symptom alleviation.
Cognitive Behavioral Therapy Group (CBT): 12 weekly sessions of 50 minutes each, utilizing structured cognitive restructuring, exposure exercises, and behavioral interventions.
Control Group: No therapeutic intervention will be provided. Participants will attend scheduled monitoring sessions for baseline and post-study assessments.
Assessment and Measurements
Neuropsychophysiological parameters will be assessed at two time points: pre-intervention (baseline) and post-intervention (after 12 weeks). Measurements will include:
Electroencephalography (EEG): To monitor brain activity patterns, focusing on prefrontal cortex activation and emotional regulation networks.
Galvanic Skin Response (GSR): To measure changes in autonomic nervous system activity and emotional arousal.
Heart Rate (HR): To evaluate cardiovascular responses and physiological stress markers.
Participants will also engage in a guided trauma discussion task during these assessments, where they reflect on their traumatic experiences in a controlled therapeutic environment. This task enhances the ecological validity of the neurophysiological data by eliciting real-time emotional and cognitive responses to trauma-related stimuli.
Psychological Scales: PTSD Checklist for DSM-5 (PCL-5), Beck Depression Inventory-II (BDI-II), and Beck Anxiety Inventory (BAI) will be used to assess symptom severity.
Study Objectives Primary Objective: Compare the effectiveness of EH and CBT in reducing PTSD symptom severity.
Secondary Objective: Evaluate differences in neuropsychophysiological responses (EEG, GSR, HR) between EH, CBT, and the control group.
Exploratory Objective: Determine if EH offers comparable or superior benefits to CBT in modulating neurophysiological and physiological stress markers.
Expected Outcomes Symptom Reduction: EH and CBT are hypothesized to significantly reduce PTSD symptoms compared to the control group.
Neurophysiological Differentiation: Differences in neurophysiological and physiological markers are expected between EH and CBT groups.
Minimal Control Improvement: The control group is expected to show minimal or no significant improvement in symptoms or physiological parameters.
This study aims to provide robust comparative data on the efficacy and neuropsychophysiological effects of EH and CBT in PTSD treatment, offering clinicians valuable insights into therapeutic decision-making. The findings will contribute to refining treatment protocols and advancing evidence-based mental health interventions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
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.
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.
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
Differences in prefrontal cortex activity, as assessed by electroencephalography (EEG), measured during baseline and Week 12 sessions. EEG metrics, including power in alpha and theta bands and activation in emotional regulation networks, will also be recorded during a guided trauma discussion task designed to elicit real-time emotional and cognitive responses to trauma-related stimuli.
Time frame: Baseline and Week 12
Evaluation of heart rate (HR) changes as a physiological marker of stress. Measurements will include baseline and Week 12 resting HR, as well as HR fluctuations during a guided trauma discussion task to capture autonomic nervous system activity in response to real-time trauma-related emotional processing.
Time frame: Baseline and Week 12
Change in anxiety severity, assessed using the Beck Anxiety Inventory (BAI). Scores will reflect self-reported anxiety symptoms.
Time frame: Baseline and Week 12
Change in depression severity, assessed using the Beck Depression Inventory-II (BDI-II). Scores will evaluate the frequency and impact of depressive symptoms.
Uskudar University
Other
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
Acronym: NEPTUNE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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