NCT06761716

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

January 1, 2025

Last Update Submit

June 2, 2025

Conditions

Keywords

Post-traumatic stress disorder (PTSD)Ericksonian HypnotherapyCognitive Behavioral Therapy (CBT)NeuropsychophysiologyEEG (Electroencephalography)GSR (Galvanic Skin Response)Heart Rate (HR)Trauma TherapyRandomized Clinical Trial (RCT)Psychological Intervention

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

EXPERIMENTAL

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.

Behavioral: Ericksonian Hypnotherapy

Cognitive Behavioral Therapy (CBT) Arm

ACTIVE COMPARATOR

Participants will receive 12 weekly sessions of 50 minutes each, utilizing cognitive restructuring, exposure exercises, and behavioral interventions to reduce PTSD symptoms.

Behavioral: Cognitive Behavioral Therapy

Control Group

NO INTERVENTION

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.

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.

Ericksonian Hypnotherapy (EH) Arm

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.

Cognitive Behavioral Therapy (CBT) Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Selami Varol Ülker, Phd

    Üsküdar University

    PRINCIPAL INVESTIGATOR
  • Metin Çınaroğlu, Phd

    Istanbul Nisantasi University

    PRINCIPAL INVESTIGATOR
  • Eda Yılmazer, Phd

    Beykoz University

    PRINCIPAL INVESTIGATOR
  • Gökben Hızlı Sayar, Prof

    Üsküdar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
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

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.

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.

Locations