Clinical trial NCT06811311: EEG Study on Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy in Generalized Anxiety Disorder
Official title: Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy on Generalized Anxiety Disorder: An EEG-Based Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Uskudar University
Sponsor class: OTHER
Collaborators: name: Istanbul Nisantasi University
name: Beykoz University
First posted: 2025-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EEG Changes in Brain Activity
timeFrame: Baseline (Pre-intervention) and Post-intervention (12 weeks)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline and Post-intervention (12 weeks)
Secondary outcomes:
measure: Generalized Anxiety Severity (Generalized Anxiety Disorder-7, GAD-7)
timeFrame: Baseline and Post-intervention (12 weeks)
measure: State and Trait Anxiety Levels (State-Trait Anxiety Inventory, STAI)
timeFrame: Baseline and Post-intervention (12 weeks)
measure: Difficulties in Emotion Regulation Scale, (DERS)
timeFrame: Baseline and Post-intervention (12 weeks)
measure: World Health Organization Quality of Life Scale, (WHOQOL-BREF)
timeFrame: Baseline and Post-intervention (12 weeks)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Üsküdar University, Neuro-Psychology Lab
Study officials:
affiliation: Üsküdar University
name: Selami Varol Ülker, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Nisantasi University
name: Metin Çınaroğlu, Phd
role: PRINCIPAL_INVESTIGATOR
References: