EEG Study on Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy in Generalized Anxiety Disorder

NCT06811311 | Recruiting

• 1 other identifier: Uskudar University EEG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Generalized Anxiety Disorder (GAD); Anxiety Disorders; Psychophysiological Disorders; Stress-Related Disorders

Keywords

Ericksonian Hypnotherapy; Hypnosis and Anxiety; EEG Neurophysiology; Anxiety Treatment; Cognitive-Emotional Regulation

Outcome Measures

Primary Outcomes (2)

• EEG Changes in Brain Activity

  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)

  Change in BAI scores (0-63, higher scores indicate more severe anxiety).

  Baseline and Post-intervention (12 weeks)

Secondary Outcomes (4)

• Generalized Anxiety Severity (Generalized Anxiety Disorder-7, GAD-7)

  Baseline and Post-intervention (12 weeks)

• State and Trait Anxiety Levels (State-Trait Anxiety Inventory, STAI)

  Baseline and Post-intervention (12 weeks)

• Difficulties in Emotion Regulation Scale, (DERS)

  Baseline and Post-intervention (12 weeks)

• World Health Organization Quality of Life Scale, (WHOQOL-BREF)

  Baseline and Post-intervention (12 weeks)

Study Arms (2)

Ericksonian Hypnotherapy Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Ericksonian Hypnotherapy BEHAVIORAL

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.

Ericksonian Hypnotherapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead
• Istanbul Nisantasi University: collaborator
• Beykoz University: collaborator

Study Sites (1)

Üsküdar University, Neuro-Psychology Lab

Istanbul, 34277, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders; Psychophysiologic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selami Varol Ülker, Phd

  Üsküdar University

  PRINCIPAL INVESTIGATOR

• Metin Çınaroğlu, Phd

  Istanbul Nisantasi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selami Varol Ülker, Phd

CONTACT

+90536-436-09-41; selamivarol.ulker@uskudar.edu.tr

Metin Çınaroğlu, Phd

CONTACT

+90532-473-20-70; metin.cinaroglu@nisantasi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This is a randomized controlled clinical trial with two parallel groups: one receiving Ericksonian hypnotherapy and the other serving as a no-treatment control group. The study examines changes in neurophysiological (EEG) and psychological (anxiety severity, emotion regulation, quality of life) parameters before and after treatment.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: February 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: September 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After the results will be published in a peer review SSCI indexed journal
• 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.

Locations

TU (1)