EEG Study on Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy in Generalized Anxiety Disorder (EEG-HypnoGAD)

February 17, 2025 updated by: Selami Varol Ülker, Uskudar University

Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy on Generalized Anxiety Disorder: An EEG-Based Clinical Study

This study examines the neurophysiological and psychological effects of Ericksonian hypnotherapy in individuals diagnosed with Generalized Anxiety Disorder (GAD). Using electroencephalography (EEG), the study aims to assess changes in brain activity and anxiety symptoms before and after treatment.

A total of 60 participants will be recruited from both governmental and private psychiatric clinics in Istanbul. Participants will be randomly assigned to either the intervention group (receiving 12 Ericksonian hypnotherapy sessions over 12 weeks) or the control group (receiving no intervention).

The primary outcome measures include changes in EEG patterns, specifically alpha, theta, and frontal asymmetry indices, and changes in anxiety severity, measured by the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder-7 (GAD-7), and State-Trait Anxiety Inventory (STAI). Secondary measures include emotional regulation (DERS) and quality of life (WHOQOL-BREF).

This study aims to provide scientific evidence on the effectiveness of Ericksonian hypnotherapy as a complementary treatment for GAD and its impact on brain function and emotional well-being.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study investigates the neurophysiological and psychological effects of Ericksonian hypnotherapy in individuals diagnosed with Generalized Anxiety Disorder (GAD) using electroencephalography (EEG). The research aims to determine whether Ericksonian hypnotherapy produces measurable changes in brain activity and anxiety symptoms.

A total of 60 participants (30 per group) will be recruited from both governmental and private psychiatric clinics in Istanbul. Participants will be diagnosed with GAD based on DSM-5 criteria and will undergo structured psychiatric evaluation before inclusion.

Study Design Intervention Group (n = 30): Participants will receive 12 individual Ericksonian hypnotherapy sessions, each lasting 90 minutes, delivered over 12 weeks. The hypnotherapy protocol will include permissive language, metaphorical storytelling, and indirect suggestions tailored to anxiety-related cognitive and emotional patterns.

Control Group (n = 30): Participants will receive no psychological intervention during the study period.

Both groups will undergo baseline and post-intervention EEG measurements and complete psychological assessments.

Primary Outcome Measures:

EEG Changes: Resting-state and task-based EEG recordings will be analyzed for alpha, theta power, frontal asymmetry indices, and event-related potentials (ERPs: P300, N200) to assess neurophysiological effects of hypnotherapy.

Anxiety Severity: Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder-7 (GAD-7), and State-Trait Anxiety Inventory (STAI) will be used to measure anxiety symptom changes.

Secondary Outcome Measures:

Emotional Regulation: Measured using the Difficulties in Emotion Regulation Scale (DERS).

Quality of Life: Evaluated with the World Health Organization Quality of Life Scale (WHOQOL-BREF).

Timeline:

Recruitment Period: February 1, 2025 - March 15, 2025 Baseline Assessments: March 2025 Intervention Period: April 1, 2025 - June 2025 Post-Intervention Assessments: July 2025 This study aims to provide scientific evidence on the efficacy of Ericksonian hypnotherapy as a complementary treatment for Generalized Anxiety Disorder by evaluating both neurophysiological and psychological changes. Findings may contribute to the development of alternative therapeutic approaches for anxiety disorders.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • İstanbul, Turkey, 34277
        • Recruiting
        • Üsküdar University, Neuro-Psychology Lab
        • Principal Investigator:
          • Selami Varol Ülker, Phd
        • Sub-Investigator:
          • Metin Çınaroğlu, Phd
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Generalized Anxiety Disorder (GAD) based on DSM-5 criteria
  • Aged 18-65 years
  • Capable of providing written informed consent
  • Fluent in Turkish (for hypnosis and assessments)
  • Not currently receiving psychotherapy or pharmacological treatment for anxiety

Exclusion Criteria:

  • Presence of comorbid psychiatric disorders (e.g., schizophrenia, bipolar disorder, major depression requiring immediate intervention)
  • History of neurological conditions (e.g., epilepsy, traumatic brain injury, stroke)
  • Current use of medications affecting EEG activity (e.g., benzodiazepines, SSRIs, antipsychotics)
  • Previous experience with hypnotherapy (to avoid expectancy bias)
  • Substance abuse or dependence within the last six months
  • Pregnancy or breastfeeding
  • Severe medical conditions that may interfere with participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ericksonian Hypnotherapy Group
Participants in this group will receive 12 individual Ericksonian hypnotherapy sessions, each lasting 90 minutes, over a 12-week period. The hypnotherapy will be delivered by trained clinicians and will incorporate permissive language, metaphorical storytelling, and indirect suggestions tailored to address cognitive and emotional patterns associated with Generalized Anxiety Disorder.
Behavioral: Ericksonian Hypnotherapy
Ericksonian hypnotherapy is a therapeutic approach that utilizes indirect suggestion, storytelling, and metaphorical language to induce a trance state and facilitate psychological change. This intervention aims to reduce anxiety symptoms, improve emotional regulation, and alter neurophysiological responses as measured by EEG. Participants will undergo 12 individual sessions, each lasting 90 minutes, over a period of 12 weeks.
No Intervention: Control Group
Participants in this group will receive no psychological intervention during the study period. They will continue their usual daily routines without structured psychotherapy, hypnosis, or additional psychological treatment. They will complete baseline and post-study assessments without receiving active treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG Changes in Brain Activity
Time Frame: Baseline (Pre-intervention) and Post-intervention (12 weeks)
Measure: Changes in alpha, theta power, and frontal asymmetry indices before and after intervention Description: EEG will be used to assess changes in resting-state brain activity and event-related potentials (ERPs: P300, N200), evaluating neurophysiological effects of Ericksonian hypnotherapy.
Baseline (Pre-intervention) and Post-intervention (12 weeks)
Beck Anxiety Inventory (BAI)
Time Frame: Baseline and Post-intervention (12 weeks)
Change in BAI scores (0-63, higher scores indicate more severe anxiety).
Baseline and Post-intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Severity (Generalized Anxiety Disorder-7, GAD-7)
Time Frame: Baseline and Post-intervention (12 weeks)
Change in GAD-7 scores (0-21, higher scores indicate more severe anxiety)
Baseline and Post-intervention (12 weeks)
State and Trait Anxiety Levels (State-Trait Anxiety Inventory, STAI)
Time Frame: Baseline and Post-intervention (12 weeks)
Change in STAI scores (20-80, higher scores indicate greater anxiety).
Baseline and Post-intervention (12 weeks)
Difficulties in Emotion Regulation Scale, (DERS)
Time Frame: Baseline and Post-intervention (12 weeks)
Change in DERS scores (36-180, higher scores indicate greater emotion regulation difficulties).
Baseline and Post-intervention (12 weeks)
World Health Organization Quality of Life Scale, (WHOQOL-BREF)
Time Frame: Baseline and Post-intervention (12 weeks)
Change in WHOQOL-BREF scores (0-100, higher scores indicate better quality of life).
Baseline and Post-intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Collaborators

Beykoz University
Istanbul Nisantasi University

Investigators

  • Principal Investigator: Selami Varol Ülker, Phd, Uskudar university
  • Principal Investigator: Metin Çınaroğlu, Phd, Istanbul Nisantasi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar University EEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified EEG data and psychological assessment scores will be shared with qualified researchers upon reasonable request. Data will be made available after study completion and publication of results, following approval by the ethics committee. Data access will be granted through a secure repository or institutional agreement.

IPD Sharing Time Frame

After the results will be published in a peer review SSCI indexed journal

IPD Sharing Access Criteria

Access to de-identified EEG and psychological assessment data will be granted to qualified researchers affiliated with recognized academic institutions or research organizations. Researchers must submit a formal data request, including a research proposal, to the study's principal investigator. Approved requests will receive access via a secure repository or institutional agreement, subject to ethical and data protection compliance.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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