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Comparison of Ericksonian Hypnotherapy and CBT in PTSD: A Clinical Trial (NEPTUNE)

U

Uskudar University

Status

Completed

Conditions

PTSD

Treatments

Behavioral: Cognitive Behavioral Therapy
Behavioral: Ericksonian Hypnotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06761716
61351342/020-395

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Ericksonian Hypnotherapy (EH) Arm
Experimental group
Description:
Participants will receive 12 weekly sessions of 50 minutes each, focusing on tailored hypnotic suggestions and subconscious communication techniques specifically designed to address PTSD symptoms.
Treatment:
Behavioral: Ericksonian Hypnotherapy
Cognitive Behavioral Therapy (CBT) Arm
Active Comparator group
Description:
Participants will receive 12 weekly sessions of 50 minutes each, utilizing cognitive restructuring, exposure exercises, and behavioral interventions to reduce PTSD symptoms.
Treatment:
Behavioral: Cognitive Behavioral Therapy
Control Group
No Intervention group
Description:
Participants 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.

Trial contacts and locations

1

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Central trial contact

Metin Çınaroğlu, Phd; Selami Varol Ülker, Phd

Data sourced from clinicaltrials.gov

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