Clinical trial NCT06761716: Comparison of Ericksonian Hypnotherapy and CBT in PTSD: A Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Post-traumatic stress disorder (PTSD)
Ericksonian Hypnotherapy
Cognitive Behavioral Therapy (CBT)
Neuropsychophysiology
EEG (Electroencephalography)
GSR (Galvanic Skin Response)
Heart Rate (HR)
Trauma Therapy
Randomized Clinical Trial (RCT)
Psychological Intervention
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel assignment model with three groups:

Ericksonian Hypnotherapy (EH) Group: 12 weekly 50-minute sessions focusing on hypnotic suggestions for PTSD symptom relief.

Cognitive Behavioral Therapy (CBT) Group: 12 weekly 50-minute sessions using cognitive and behavioral techniques for PTSD management.

Control Group: No therapeutic intervention; participants undergo baseline and post-study assessments only.

Primary Outcome: Reduction in PTSD symptom severity (PCL-5, BDI-II, BAI). Secondary Outcome: Changes in neurophysiological and physiological markers (EEG, GSR, HR).
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in PTSD Symptom Severity
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Changes in Brain Activity (EEG)
timeFrame: Baseline and Week 12
measure: Changes in Heart Rate (HR)
timeFrame: Baseline and Week 12
measure: Reduction in Anxiety Symptoms
timeFrame: Baseline and Week 12
measure: Reduction in Depression Symptoms
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Üsküdar University
Study officials:
affiliation: Üsküdar University
name: Selami Varol Ülker, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Nisantasi University
name: Metin Çınaroğlu, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Beykoz University
name: Eda Yılmazer, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Üsküdar University
name: Gökben Hızlı Sayar, Prof
role: STUDY_CHAIR
References: