Generalized Anxiety Disorder (GAD)EEG-HypnoGADNCT06811311
EEG Study on Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy in Generalized Anxiety Disorder
A study testing Ericksonian Hypnotherapy in people with Generalized Anxiety Disorder (GAD) and Anxiety Disorders, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Anxiety Disorders, Psychophysiological Disorders
- What is being tested?
- Ericksonian Hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Üsküdar University, Neuro-Psychology Lab
Istanbul, 34277
Selami Varol Ülker, Phd, +905364360941, selamivarolulker@uskudar.edu.tr
Metin Çınaroğlu, Phd, 09053247320, metin.cinaroglu@nisantasi.edu.tr
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder (GAD), Anxiety Disorders, Psychophysiological Disorders, Stress-Related Disorders
- Being tested
- Ericksonian Hypnotherapy
- Keywords
- Ericksonian Hypnotherapy, Hypnosis and Anxiety, EEG Neurophysiology, Anxiety Treatment, Cognitive-Emotional Regulation
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders, Psychophysiologic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ericksonian HypnotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Pre-intervention) and Post-intervention (12 weeks)
Beck Anxiety Inventory (BAI)
Change in BAI scores (0-63, higher scores indicate more severe anxiety).
Measured: Baseline and Post-intervention (12 weeks)
Secondary outcomes (4)
Generalized Anxiety Severity (Generalized Anxiety Disorder-7, GAD-7)
Change in GAD-7 scores (0-21, higher scores indicate more severe anxiety)
Measured: Baseline and Post-intervention (12 weeks)
State and Trait Anxiety Levels (State-Trait Anxiety Inventory, STAI)
Change in STAI scores (20-80, higher scores indicate greater anxiety).
Measured: Baseline and Post-intervention (12 weeks)
Difficulties in Emotion Regulation Scale, (DERS)
Change in DERS scores (36-180, higher scores indicate greater emotion regulation difficulties).
Measured: Baseline and Post-intervention (12 weeks)
World Health Organization Quality of Life Scale, (WHOQOL-BREF)
Change in WHOQOL-BREF scores (0-100, higher scores indicate better quality of life).
Measured: Baseline and Post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Nisantasi University, Beykoz University
- Responsible party
- Principal investigator, Selami Varol Ülker, Uskudar University
- Investigators
- Selami Varol Ülker, Phd, Principal investigator, Üsküdar UniversityMetin Çınaroğlu, Phd, Principal investigator, Istanbul Nisantasi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811311
- Sponsor's protocol ID
- Uskudar University EEG
- Acronym
- EEG-HypnoGAD
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological and Psychological Effects of Ericksonian Hypnotherapy on Generalized Anxiety Disorder: An EEG-Based Clinical Study
- ClinicalTrials.gov ID
- NCT06811311
- Acronym / sponsor ID
- EEG-HypnoGAD / Uskudar University EEG
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Istanbul Nisantasi University, Beykoz University
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ericksonian Hypnotherapy Group | Experimental | Behavioral: Ericksonian HypnotherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ericksonian HypnotherapyEricksonian 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. | Behavioural | Ericksonian Hypnotherapy Group |
Primary outcome
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.
Beck Anxiety Inventory (BAI)
Time frame: Baseline and Post-intervention (12 weeks)
Change in BAI scores (0-63, higher scores indicate more severe anxiety).
4 secondary outcomes
Generalized Anxiety Severity (Generalized Anxiety Disorder-7, GAD-7)
Time frame: Baseline and Post-intervention (12 weeks)
State and Trait Anxiety Levels (State-Trait Anxiety Inventory, STAI)
Time frame: Baseline and Post-intervention (12 weeks)
Difficulties in Emotion Regulation Scale, (DERS)
Time frame: Baseline and Post-intervention (12 weeks)
World Health Organization Quality of Life Scale, (WHOQOL-BREF)
Time frame: Baseline and Post-intervention (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Selami Varol Ülker, Phd principal investigator
Üsküdar University
Metin Çınaroğlu, Phd principal investigator
Istanbul Nisantasi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ericksonian Hypnotherapy in people with Generalized Anxiety Disorder (GAD) and Anxiety Disorders, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selami Varol Ülker, Phd (+90536-436-09-41, selamivarol.ulker@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Changes in Brain Activity (time frame: Baseline (Pre-intervention) and Post-intervention (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.