Eye Movements Desensitization and Reprocessing Intervention in Preventing Craving in Alcohol Use Disorder

NCT05606900 | Completed

• 1 other identifier: 23-8.2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to examine the effect of a psychotherapy model that is expected to affect alcohol cravings in adults aged 18-65 years who are being treated for alcohol use disorder at a clinic. The psychotherapy intervention is expected to affect other variables such as clinical symptom level, self-efficacy level, and functionality level. This protocol is called addiction-focused eye movement desensitization and reprocessing (addiction-focused EMDR). Patients found suitable for the study will be divided into experimental and control groups. The intervention will be applied to the experimental group and not to the control group. At the end of the intervention, the effect of the intervention primarily on the level of craving will be compared with that of the control group. The intervention is expected to reduce the level of craving. The intervention is expected to have an impact on the other variables mentioned as well.

Conditions

Alcohol Use Disorder; Alcohol Craving

Keywords

alcohol use disorder; alcohol craving; eye movement desensitization reprocessing; emdr; controlled trial

Outcome Measures

Primary Outcomes (6)

• Frequency of alcohol craving assessed by Penn Alcohol Craving Scale

  This outcome refers to the change in scores of the frequency of alcohol craving obtained from measurements at two time points between experiment and control groups. Penn Alcohol Craving Scale is the measurement tool to measure the craving frequency.

  The change scores of the frequency of alcohol craving between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).

• Frequency of alcohol craving assessed by Penn Alcohol Craving Scale

  This outcome refers to the change in scores of the frequency of alcohol craving obtained from measurements at two time points between experiment and control groups. Penn Alcohol Craving Scale is the measurement tool to measure the craving frequency.

  The change scores of the frequency of alcohol craving between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).

• Severity of alcohol craving assessed by Penn Alcohol Craving Scale

  This outcome refers to the change in scores of the severity level of alcohol craving obtained from measurements at two time points between experiment and control groups. Penn Alcohol Craving Scale is the measurement tool to measure the level of craving severity.

  The change scores of the severity level of alcohol craving between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).

• Severity of alcohol craving assessed by Penn Alcohol Craving Scale

  This outcome refers to the change in scores of the severity level of alcohol craving obtained from measurements at two time points between experiment and control groups. Penn Alcohol Craving Scale is the measurement tool to measure the level of craving severity.

  The change scores of the severity level of alcohol craving between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).

• Control level over alcohol craving assessed by Craving Experience Scale

  This outcome refers to the change in scores of the control level over alcohol craving obtained from measurements at two time points between experiment and control groups. Craving Experience Scale is the measurement tool to measure the level of control over craving.

  The change scores of the control level over alcohol craving between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).

• Control level over alcohol craving assessed by Craving Experience Scale

  This outcome refers to the change in scores of the control level over alcohol craving obtained from measurements at two time points between experiment and control groups. Craving Experience Scale is the measurement tool to measure the level of control over craving.

  The change scores of the control level over alcohol craving between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).

Secondary Outcomes (6)

• Clinical symptom levels assessed by Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale

  The change scores of the clinical symptoms between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).

• Clinical symptom levels assessed by Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Scale

  The change scores of the clinical symptoms between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).

• Self-efficacy level assessed by General Self-Efficacy Scale

  The change scores of the level of self-efficacy between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).

• Self-efficacy level assessed by General Self-Efficacy Scale

  The change scores of the level of self-efficacy between the control and the experiment groups will be compared between the intervention completion (t1)(estimated to be 8 weeks) and 4-week follow-up (t2).

• General functioning level assessed by The General Assessment of Functioning Scale

  The change scores of the level of general functionality between the control and the experiment groups will be compared between the baseline measure (t0) and the intervention completion (t1)(estimated to be 8 weeks).

Study Arms (2)

Experiment group

EXPERIMENTAL

Twenty volunteer patients between the ages of 18-65 who applied to the addiction polyclinic and were diagnosed with alcohol use disorder (AUD) constitute the sample of the experimental group. In addition to the standard alcohol addiction treatment (TAU) applied in the addiction polyclinic, the patients in the experimental group will be given addiction-focused eye movements, desensitization and reprocessing (AF-EMDR) psychotherapy. AF-EMDR consists of 3 sessions, with a total duration of 3 weeks. Each session will last between 1 and 1 and a half hours, depending on individual differences. Psychotherapy sessions will be conducted as face-to-face and individual sessions. TAU includes the medical treatment for AUD and motivational interviews if necessary, administered by the psychiatrist in the addiction polyclinic, where the research is conducted. Structured psychotherapy is not used in TAU practice.

Behavioral: addiction-focused eye movements desensitization and reprocessing (AF-EMDR)

Control group

NO INTERVENTION

The sample of the control group consists of 20 volunteer patients between the ages of 18-65 who applied to the addiction polyclinic and were diagnosed with alcohol use disorder (AUD). Patients in the control group will be given standard treatment of alcohol use disorder (TAU). The duration and dosage of TAU are regulated by the psychiatrist in the polyclinic specific to the patient. During the duration of AF-EMDR to the experimental group, patients in the control group will be on the waiting list and will not receive AF-EMDR intervention. If AF-EMDR intervention is concluded as beneficial for the patients in the experimental group after the analysis of the final measurements (1-month follow-up measurements), the same AF-EMDR intervention will be applied to the patients in the control group.

Interventions

addiction-focused eye movements desensitization and reprocessing (AF-EMDR) BEHAVIORAL

AF-EMDR includes desensitization and functional reprocessing of the targeted memory or the moment with lateral eye movements. In each session of the psychotherapy, which will be applied as 3 sessions, a memory or a moment that causes alcohol craving will be practised. The processing will continue until the patient becomes desensitized to the memory or the moment that cause the craving. In the first session, a memory of craving will be discussed, in the second session a current trigger that causes craving, and in the third session, a moment that is thought to cause craving in the future will be focused.

Experiment group

Eligibility Criteria

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

You may qualify if:

• Having the criteria for the diagnosis of alcohol use disorder according to DSM-5,
• Continuing or completing the standard treatment applied in the addiction clinic,
• Being between the ages of 18-65.

You may not qualify if:

• As a result of the clinical interview, meeting the criteria for any of the disorders included in the classifications of:
• "Bipolar and related disorders" with psychotic features,
• "Depression disorders" with psychotic features,
• "Dissociative disorders" such as depersonalization, derealization, dissociative identity disorder,
• "Schizophrenia spectrum and disorders leading to psychosis" such as schizophrenia, schizotypal personality disorder, schizoaffective disorder,
• Receiving any psychological or medical treatment other than the standard alcohol use disorder treatment administered in the Addiction Polyclinic,
• Having at least one of cardiovascular diseases, vertigo, epilepsy or eye diseases.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Substance Abuse, Toxicology and Pharmaceutical Sciences Institute

Izmir, 35040, Turkey (Türkiye)

Location

Related Publications (13)

• Boening JA. Neurobiology of an addiction memory. J Neural Transm (Vienna). 2001;108(6):755-65. doi: 10.1007/s007020170050.

  PMID: 11478425 BACKGROUND

• Carletto S, Oliva F, Barnato M, Antonelli T, Cardia A, Mazzaferro P, Raho C, Ostacoli L, Fernandez I, Pagani M. EMDR as Add-On Treatment for Psychiatric and Traumatic Symptoms in Patients with Substance Use Disorder. Front Psychol. 2018 Jan 11;8:2333. doi: 10.3389/fpsyg.2017.02333. eCollection 2017.

  PMID: 29375445 BACKGROUND

• Castelnuovo G, Fernandez I, Amann BL. Editorial: Present and Future of EMDR in Clinical Psychology and Psychotherapy. Front Psychol. 2019 Sep 27;10:2185. doi: 10.3389/fpsyg.2019.02185. eCollection 2019. No abstract available.

  PMID: 31611832 BACKGROUND

• Hase M, Schallmayer S, Sack M. EMDR reprocessing of the addiction Memory: pretreatment, posttreatment, and 1-month follow-up. Journal of EMDR Practice and Research. 2008; 2(3):170-179. doi: 10.1891/1933-3196.2.3.170.

  BACKGROUND

• Littel M, van den Hout MA, Engelhard IM. Desensitizing Addiction: Using Eye Movements to Reduce the Intensity of Substance-Related Mental Imagery and Craving. Front Psychiatry. 2016 Feb 8;7:14. doi: 10.3389/fpsyt.2016.00014. eCollection 2016.

  PMID: 26903888 BACKGROUND

• Luber M. Eye Movement Desensitization and Reprocessing (EMDR) Scripted Protocols: Special Populations. New York: Springer Publishing Company. 2010.

  BACKGROUND

• Markus W, Hornsveld HK, Burk WJ, de Weert-van Oene GH, Becker ES, DeJong CAJ. Addiction-Focused Eye Movement Desensitization and Reprocessing Therapy as an Adjunct to Regular Outpatient Treatment for Alcohol Use Disorder: Results From a Randomized Clinical Trial. Alcohol Clin Exp Res. 2020 Jan;44(1):272-283. doi: 10.1111/acer.14249. Epub 2019 Dec 17.

  PMID: 31758556 BACKGROUND

• Markus W, de Weert-van Oene GH, Becker ES, DeJong CA. A multi-site randomized study to compare the effects of Eye Movement Desensitization and Reprocessing (EMDR) added to TAU versus TAU to reduce craving and drinking behavior in alcohol dependent outpatients: study protocol. BMC Psychiatry. 2015 Mar 18;15:51. doi: 10.1186/s12888-015-0431-z.

  PMID: 25884223 BACKGROUND

• Perez-Dandieu B, Tapia G. Treating Trauma in Addiction with EMDR: A Pilot Study. J Psychoactive Drugs. 2014 Oct-Dec;46(4):303-9. doi: 10.1080/02791072.2014.921744.

  PMID: 25188700 BACKGROUND

• Robbins TW, Ersche KD, Everitt BJ. Drug addiction and the memory systems of the brain. Ann N Y Acad Sci. 2008 Oct;1141:1-21. doi: 10.1196/annals.1441.020.

  PMID: 18991949 BACKGROUND

• Shapiro F. The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: addressing the psychological and physical symptoms stemming from adverse life experiences. Perm J. 2014 Winter;18(1):71-7. doi: 10.7812/TPP/13-098.

  PMID: 24626074 BACKGROUND

• Shapiro F. Eye Movement Desensitization and Reprocessing (EMDR) Therapy: Basic Principles, Protocols, and Procedures. New York: Guilford Publications. 2007.

  BACKGROUND

• Sinha R. New findings on biological factors predicting addiction relapse vulnerability. Curr Psychiatry Rep. 2011 Oct;13(5):398-405. doi: 10.1007/s11920-011-0224-0.

  PMID: 21792580 BACKGROUND

Related Links

• World Health Organization (2013). Guidelines for the management of conditions that are specifically related to stress.
• World Health Organization (2018). Global status report on alcohol and health.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Zeki Yuncu, Prof

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The randomisation of patients to one of the study arms will be carried out by another researcher other than the researcher who will practice the intervention. With this masking method, it is planned to assign the patients to the groups without any bias of the psychotherapist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was designed as an open-label randomized controlled trial.

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 7, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)