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PTSDNEPTUNENCT06761716

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

A study testing Ericksonian Hypnotherapy and Cognitive Behavioral Therapy in people with PTSD, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
PTSD
What is being tested?
Ericksonian Hypnotherapy and Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2024to 15 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Üsküdar University

    Istanbul, Istanbul, 34277

Other trials in Turkey (Türkiye)

About this study

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

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:

Read more

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.

Read the 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.

Conditions
PTSD
Being tested
Ericksonian Hypnotherapy, Cognitive Behavioral Therapy
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
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ericksonian HypnotherapyBehavioural

    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.

  • Cognitive Behavioral TherapyBehavioural

    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.

Study groups in NCT06761716
Study groupRoleWhat they receive
Ericksonian Hypnotherapy (EH) ArmExperimentalParticipants will receive 12 weekly sessions of 50 minutes each, focusing on tailored hypnotic suggestions and subconscious communication techniques specifically designed to address PTSD symptoms.
Receives: Behavioral: Ericksonian Hypnotherapy
Cognitive Behavioral Therapy (CBT) ArmActive comparatorParticipants will receive 12 weekly sessions of 50 minutes each, utilizing cognitive restructuring, exposure exercises, and behavioral interventions to reduce PTSD symptoms.
Receives: Behavioral: Cognitive Behavioral Therapy
Control GroupNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 12

Secondary outcomes (4)
  1. Changes in Brain Activity (EEG)

    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.

    Measured: Baseline and Week 12

  2. Changes in Heart Rate (HR)

    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.

    Measured: Baseline and Week 12

  3. Reduction in Anxiety Symptoms

    Change in anxiety severity, assessed using the Beck Anxiety Inventory (BAI). Scores will reflect self-reported anxiety symptoms.

    Measured: Baseline and Week 12

  4. Reduction in Depression Symptoms

    Change in depression severity, assessed using the Beck Depression Inventory-II (BDI-II). Scores will evaluate the frequency and impact of depressive symptoms.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start15 Nov 2024
  3. Primary completion15 Mar 2025
  4. Study completion15 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06761716
Sponsor's protocol ID
61351342/020-395
Acronym
NEPTUNE
Status last verified
Jun 2025
First submitted
1 Jan 2025
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Ericksonian Hypnotherapy and Cognitive Behavioral Therapy in people with PTSD, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in PTSD Symptom Severity (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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