Comparing Combined Behavioral Intervention and Ericksonian Hypnotherapy for Alcohol Addiction

NCT06916754 | Recruiting

• 1 other identifier: BEYKOZ-EH-CBI-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). 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. 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.

Conditions

Alcohol-Related Disorders; Alcoholism; Substance-related Disorders

Keywords

Ericksonian Hypnosis; Hypnotherapy; Cognitive Behavioral Therapy; Motivational Interviewing; Relapse Prevention; Craving; Substance Craving; Psychotherapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Change in Craving Beliefs (CBQ)

  Baseline to Week 6, Week 12, and Week 24

• Change in Craving Typologies (CTQ)

  Baseline to Week 6, Week 12, and Week 24

• Change in Depression Symptoms (BDI-II)

  Baseline to Week 6, Week 12, and Week 24

• Change in Anxiety Symptoms (BAI)

  Baseline to Week 6, Week 12, and Week 24

• Change in Quality of Life (WHOQOL-BREF)

  Baseline to Week 6, Week 12, and Week 24

Study Arms (3)

Combined Behavioral Intervention (CBI)

EXPERIMENTAL

Participants 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.

Behavioral: Combined Behavioral Intervention

Ericksonian Hypnotherapy (EH)

EXPERIMENTAL

Participants 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.

Behavioral: Ericksonian Hypnotherapy

Control (Standard Care Information)

NO INTERVENTION

Participants 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.

Interventions

Combined Behavioral Intervention BEHAVIORAL

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.

Combined Behavioral Intervention (CBI)

Ericksonian Hypnotherapy BEHAVIORAL

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.

Ericksonian Hypnotherapy (EH)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Beykoz University

Istanbul, 34820, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alcohol-Related Disorders; Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gökben Hızlı Sayar, Prof

  Üsküdar University

  STUDY CHAIR

• Selami Varol Ülker, Phd

  Üsküdar University

  STUDY DIRECTOR

• Metin Çınaroğlu, Phd

  Istanbul Nisantasi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eda Yılmazer, Phd

CONTACT

+905322575880; edayilmazer@beykoz.edu.tr

Metin Çınaroğlu, Phd

CONTACT

+905324732070; metincinaroglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors who collect follow-up and post-treatment data will be blinded to participants' group assignment. Participants and therapists are not blinded due to the nature of behavioral interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: March 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: February 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available upon request starting immediately after the publication of the main study findings in a peer-reviewed journal. Data will remain accessible for 36 months after the date of publication.
• Access Criteria: Access will be granted to qualified researchers affiliated with academic or non-profit institutions who provide a methodologically sound proposal approved by the study team. Requesters must sign a data use agreement. Access will include de-identified individual participant data and supporting documents. Requests can be submitted via email to the principal investigator following publication.

Locations

TU (1)