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临床试验/NCT06916754
NCT06916754招募中不适用

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

Beykoz University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
2
主要终点
Change in Alcohol Consumption (TLFB)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

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

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in Alcohol Consumption (TLFB)

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

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.

次要结局

  • Change in Quality of Life (WHOQOL-BREF)(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 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 Readiness to Change (SOCRATES)(Baseline to Week 6, Week 12, and Week 24)

研究者

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

Eda Yilmazer

Principal Investigator

Beykoz University

研究点 (2)

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