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Alcohol-Related DisordersNCT06916754

Comparing Combined Behavioral Intervention and Ericksonian Hypnotherapy for Alcohol Addiction

A study testing Combined Behavioral Intervention and Ericksonian Hypnotherapy in people with Alcohol-Related Disorders and Alcoholism, run by Beykoz University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical study is being conducted to compare the effectiveness of two psychological treatments for alcohol addiction: Combined Behavioral Intervention (CBI) and Ericksonian Hypnotherapy (EH). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Combined Behavioral Intervention and Ericksonian Hypnotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 1 Feb 2026
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

  • Aged between 18 and 65 years
  • Meets DSM-5 diagnostic criteria for Alcohol Use Disorder (mild to severe)
  • Medically and psychiatrically stable as determined by a clinician
  • Willing and able to participate in weekly sessions over a 12-week period
  • Provides informed consent

Who cannot join

  • Current diagnosis of a severe psychiatric disorder (e.g., psychotic disorder, bipolar I disorder)
  • Significant cognitive impairment that would interfere with treatment participation
  • Participation in another structured addiction treatment during the study period
  • Current use of psychotropic medications that may influence outcome measures (as assessed by the clinical team)
  • Unstable medical condition requiring immediate intervention
  • Pregnancy or planning to become pregnant during the study period

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eda Yılmazer, Phd contact

+905322575880

edayilmazer@beykoz.edu.tr

Metin Çınaroğlu, Phd contact

+905324732070

metincinaroglu@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Beykoz University

    Istanbul, 34820

    Eda Yılmazer, Phd, +905322575880, edayilmazer@beykoz.edu.tr

    Metin Çınaroğlu, Phd, +905324732070, metincinaroglu@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparing the Efficacy of Combined Behavioral Intervention and Ericksonian Hypnotherapy in the Treatment of Alcohol Addiction: A Randomized Controlled Trial

This clinical study is being conducted to compare the effectiveness of two psychological treatments for alcohol addiction: Combined Behavioral Intervention (CBI) and Ericksonian Hypnotherapy (EH). The purpose of the study is to determine whether Ericksonian Hypnotherapy, a more personalized and indirect therapeutic method, is equal to or more effective than the gold-standard approach, Combined Behavioral Intervention, in helping individuals reduce their alcohol consumption and improve psychological well-being.

Alcohol addiction is a serious condition that affects mental, emotional, and physical health. Many treatment options exist, but not all individuals respond in the same way. This study aims to evaluate two different types of therapy in a structured way, to better understand which works best, for whom, and under what circumstances.

Read more

The study will include 90 adult participants diagnosed with Alcohol Use Disorder (AUD). Participants will be randomly assigned to one of three groups: (1) a group receiving weekly sessions of Combined Behavioral Intervention, (2) a group receiving weekly sessions of Ericksonian Hypnotherapy, or (3) a control group receiving general educational materials about alcohol addiction. Treatment will last for 12 weeks, and all participants will be followed up three months after the last session to assess long-term effects.

Throughout the study, researchers will measure changes in alcohol consumption, alcohol craving, mental health symptoms (such as depression and anxiety), quality of life, and motivation to change. The findings of this study may help improve the way alcohol addiction is treated by offering evidence on alternative approaches such as hypnotherapy.

Read the detailed description

Alcohol Use Disorder (AUD) is a persistent and relapsing condition with profound personal, familial, and societal consequences. Although several psychosocial interventions have demonstrated efficacy, there remains an unmet need for alternative, accessible, and effective therapeutic approaches that can be tailored to individual needs and cognitive styles. Combined Behavioral Intervention (CBI), which integrates Motivational Interviewing (MI), Cognitive Behavioral Therapy (CBT), and relapse prevention strategies, is regarded as a gold-standard modality for the treatment of alcohol addiction. Ericksonian Hypnotherapy (EH), in contrast, represents a less traditional but increasingly recognized intervention that uses indirect suggestion, personalized metaphor, and trance-based language to target the unconscious processes that often underlie maladaptive behaviors such as substance use.

This randomized controlled trial (RCT) aims to directly compare the clinical efficacy of CBI and EH in reducing alcohol use and related psychological symptoms among adults diagnosed with AUD. The trial also seeks to assess differential impacts on craving typologies, cognitive beliefs related to addiction, mental health symptoms, quality of life, and motivation to change. While CBI is grounded in conscious, structured therapeutic engagement and skill acquisition, EH offers a fluid and individualized therapeutic experience that may bypass conscious resistance, making it especially relevant for individuals who struggle with conventional, didactic approaches.

A total of 90 adult participants will be enrolled, all of whom will meet DSM-5 diagnostic criteria for Alcohol Use Disorder (mild to severe), confirmed by a qualified psychiatrist. Participants will be recruited through private psychiatric clinics and general psychiatry outpatient services in Istanbul, Turkey, leveraging a network of collaborating clinicians who will refer eligible individuals. After informed consent and baseline screening, participants will be randomly assigned in equal numbers (1:1:1) to one of three study arms: (1) Combined Behavioral Intervention (CBI), (2) Ericksonian Hypnotherapy (EH), or (3) control group receiving general educational materials and referral guidance without structured psychotherapy.

Participants in the CBI group will attend 12 weekly individual or small group sessions (depending on scheduling and logistics), each lasting approximately 60 minutes. These sessions will systematically cover motivation enhancement, cognitive restructuring, coping with triggers, and relapse prevention strategies. The EH group will also receive 12 weekly sessions lasting approximately 45-60 minutes each. These sessions will employ individualized hypnotic induction techniques, ego-strengthening interventions, post-hypnotic suggestions, and metaphoric storytelling designed to promote subconscious readiness for change. Audio recordings will be provided to support daily self-hypnosis practice at home, though this is not mandatory. The control group will receive psychoeducational materials related to alcohol addiction, as well as referral contact information for local support services, but will not engage in any structured therapeutic process.

The study will involve repeated measurement of both behavioral and psychological variables across four timepoints: baseline (T0), midpoint of treatment at Week 6 (T1), post-treatment at Week 12 (T2), and follow-up at Month 10 (T3). The primary outcome is alcohol consumption, measured by the Timeline Follow-Back (TLFB) method-a validated, retrospective self-report tool assessing daily drinking over the past 30 days.

Secondary outcomes include both cognitive and phenomenological dimensions of craving, measured using the Craving Beliefs Questionnaire (CBQ) and the Craving Typology Questionnaire (CTQ), respectively. These instruments offer a dual lens into the subjective experience of craving: CBQ focuses on belief systems that maintain substance use (e.g., perceived uncontrollability), while CTQ distinguishes between obsessive, relief-oriented, and reward-based craving patterns. Depression and anxiety symptoms will be assessed using either the Beck Depression Inventory-II (BDI-II) or Patient Health Questionnaire-9 (PHQ-9) and the Beck Anxiety Inventory (BAI) or Generalized Anxiety Disorder-7 (GAD-7), depending on participant suitability and assessment availability. Broader quality-of-life impacts will be measured using the WHO Quality of Life-BREF (WHOQOL-BREF) or alternatively the Short Form-12 (SF-12). Readiness to change will be assessed with the Turkish version of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES).

Adherence to treatment (session attendance) and participant satisfaction with therapy will also be recorded, alongside reasons for withdrawal if applicable. Outcome data will be collected and coded by trained, blinded assessors who will have no role in therapy delivery or treatment group assignment.

Statistical analysis will follow an intention-to-treat (ITT) principle. The primary outcome-change in alcohol consumption-will be analyzed using linear mixed-effects modeling or repeated measures ANOVA with fixed effects for group, time, and group-by-time interactions. Secondary analyses will explore group differences in craving, mental health symptoms, and readiness to change using similar longitudinal methods. Multiple imputation or last observation carried forward (LOCF) strategies will be employed to address missing data. Subgroup analyses based on baseline severity and comorbidity may be conducted if sample size permits.

The central hypothesis of the study is that Ericksonian Hypnotherapy will be non-inferior or superior to Combined Behavioral Intervention in reducing alcohol use and related craving. It is further hypothesized that while CBI will lead to stronger improvements in belief-driven cognitive mechanisms, EH may be more effective in addressing the emotional and phenomenological dimensions of craving. Both active treatments are expected to yield superior outcomes compared to the control group.

By testing a structured comparison between a widely used evidence-based model (CBI) and a less conventional yet promising method (EH), this study has the potential to inform clinical decision-making, diversify treatment options, and contribute new insights into how psychological and hypnotic methods can be integrated into substance use treatment. The use of both cognitive and experiential craving assessments, together with validated instruments and a robust design, supports the methodological rigor of this trial.

Being tested
Combined Behavioral Intervention, Ericksonian Hypnotherapy
Keywords
Ericksonian Hypnosis, Hypnotherapy, Cognitive Behavioral Therapy, Motivational Interviewing, Relapse Prevention, Craving, Substance Craving, Psychotherapy
Medical subject headings
Alcohol-Related Disorders, Alcoholism, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Behavioral InterventionBehavioural

    The intervention includes 12 weekly sessions integrating Motivational Interviewing, Cognitive Behavioral Therapy, and relapse prevention strategies. Techniques include enhancing motivation to change, identifying cognitive distortions, managing high-risk situations, and developing alternative coping strategies.

  • Ericksonian HypnotherapyBehavioural

    This therapy includes 12 weekly sessions involving individualized trance induction, indirect suggestion, therapeutic metaphor, and ego-strengthening techniques. The sessions follow Ericksonian principles and are delivered by certified hypnotherapists.

Study groups in NCT06916754
Study groupRoleWhat they receive
Combined Behavioral Intervention (CBI)ExperimentalParticipants in this arm will receive a manualized Combined Behavioral Intervention consisting of 12 weekly sessions, each approximately 60 minutes. The intervention includes elements of Motivational Interviewing, Cognitive Behavioral Therapy, and relapse prevention strategies. Sessions are delivered either individually by licensed therapists trained in behavioral therapy.
Receives: Behavioral: Combined Behavioral Intervention
Ericksonian Hypnotherapy (EH)ExperimentalParticipants in this arm will receive Ericksonian Hypnotherapy in 12 weekly individual sessions, each approximately 45-60 minutes. The intervention uses personalized trance induction, metaphorical storytelling, ego-strengthening, and post-hypnotic suggestions.
Receives: Behavioral: Ericksonian Hypnotherapy
Control (Standard Care Information)No interventionParticipants in this group will not receive structured psychotherapy but will be provided with psychoeducational brochures and referral resources related to alcohol addiction treatment. They will complete the same assessment schedule as the other groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Alcohol Consumption (TLFB)

    Self-reported alcohol consumption measured using the Timeline Follow-Back (TLFB) method. TLFB assesses the number of standard drinks consumed each day over the past 30 days. Higher scores indicate greater alcohol use. A reduction in total drinks consumed per month represents clinical improvement.

    Measured: Baseline to Week 6, Week 12, and Month 10 (3-Month Follow-Up)

Secondary outcomes (6)
  1. Change in Craving Beliefs (CBQ)

    Craving Beliefs Questionnaire (CBQ) measures dysfunctional beliefs about alcohol craving. Scores range from 20 to 140, with higher scores indicating more maladaptive craving-related beliefs. A reduction in CBQ scores indicates improvement.

    Measured: Baseline to Week 6, Week 12, and Week 24

  2. Change in Craving Typologies (CTQ)

    Craving Typology Questionnaire (CTQ) measures three dimensions of craving: obsessive, relief, and reward craving. Each subscale ranges from 0 to 36, with higher scores indicating greater craving intensity. Reductions in subscale scores reflect improvement.

    Measured: Baseline to Week 6, Week 12, and Week 24

  3. Change in Depression Symptoms (BDI-II)

    Depressive symptoms assessed using either the Beck Depression Inventory-II (range: 0-63). Higher scores indicate more severe depression. A decrease in total score reflects symptom improvement.

    Measured: Baseline to Week 6, Week 12, and Week 24

  4. Change in Anxiety Symptoms (BAI)

    Anxiety symptoms measured with the Beck Anxiety Inventory (range: 0-63). Higher scores reflect greater anxiety severity. A reduction in total score indicates clinical improvement.

    Measured: Baseline to Week 6, Week 12, and Week 24

  5. Change in Quality of Life (WHOQOL-BREF)

    Measured using the WHOQOL-BREF (domain scores range from 4 to 20, with higher scores indicating better quality of life). Increases in scores represent improved well-being.

    Measured: Baseline to Week 6, Week 12, and Week 24

  6. Change in Readiness to Change (SOCRATES)

    SOCRATES measures motivation to change alcohol use behavior across three dimensions: Recognition, Ambivalence, and Taking Steps. Subscales range from 7 to 35. Higher scores represent greater readiness to change. Improvements reflect increased motivation.

    Measured: Baseline to Week 6, Week 12, and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start1 Mar 2025
  3. Primary completion15 Nov 2025 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Three-arm, parallel-group randomized controlled trial with equal allocation to Combined Behavioral Intervention (CBI), Ericksonian Hypnotherapy (EH), or control (standard care information). Each participant receives only one type of intervention throughout the 12-week treatment period.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06916754
Sponsor's protocol ID
BEYKOZ-EH-CBI-2025
Status last verified
Apr 2025
First submitted
1 Apr 2025
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in published articles will be shared. This includes data on alcohol use, craving (CBQ and CTQ), depression, anxiety, quality of life, motivation to change, and session attendance. Data will be made available to qualified researchers affiliated with academic or nonprofit institutions upon request and approval. Data will be shared through secure institutional repositories.

Questions about this trial

What is this clinical trial studying?

A study testing Combined Behavioral Intervention and Ericksonian Hypnotherapy in people with Alcohol-Related Disorders and Alcoholism, run by Beykoz 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 6 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 16 Apr 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 Eda Yılmazer, Phd (+905322575880, edayilmazer@beykoz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alcohol Consumption (TLFB) (time frame: Baseline to Week 6, Week 12, and Month 10 (3-Month Follow-Up)). 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 16 Apr 2025.

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