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临床试验/NCT06811311
NCT06811311招募中不适用

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

Uskudar University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
EEG Changes in Brain Activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Ericksonian Hypnotherapy (Behavioral)

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.

结局指标

主要结局

EEG Changes in Brain Activity

时间窗: 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.

Beck Anxiety Inventory (BAI)

时间窗: Baseline and Post-intervention (12 weeks)

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

次要结局

  • 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))

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selami Varol Ülker

Dr

Uskudar University

研究点 (1)

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