Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients

• ClinicalTrials.gov Identifier: NCT01828866
• Recruitment Status: Completed
• First Posted: April 11, 2013
• Last Update Posted: September 15, 2016
• Sponsor: IrisZorg
• Collaborators: Fonds Psychische Gezondheid; Dutch EMDR Association; EMDR Research Foundation
• Information provided by (Responsible Party): W. Markus, IrisZorg

Study Description

Brief Summary:

One interesting approach to the treatment of addiction is the use of Eye Movement Desensitization and Reprocessing (EMDR) (Shapiro, 1989). Although research on the feasibility and efficacy of EMDR on addiction is limited and often lacks methodological rigor, the results are promising and suggest that further research on this subject is warranted.

This proposal consists of two studies to test and determine the acceptability, feasibility and efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol dependent outpatients as well as to gain further understanding in underlying working mechanisms.

Condition or disease	Intervention/treatment	Phase
Alcohol Dependence	Behavioral: EMDR; Behavioral: Community Reinforcement Approach	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: From Feasibility to Efficacy: the Use of EMDR to Reduce Craving and Drinking Behaviour in Alcohol Dependent Outpatients - A Multiple Baseline Study and Randomized Controlled Trial (RCT)
• Study Start Date: September 2013
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Community Reinforcement Approach; Treatment as usual, provided in out-patient setting	Behavioral: Community Reinforcement Approach; CRA is based on behavioural therapy principles: Functional analysis; Communication skills; Problem-solving skills; Sobriety sampling; Social networking; Refusal of substances; Reinforcing activities; Relapse management; Medication monitoring; Other Name: CRA
Experimental: Community Reinforcement Approach + EMDR; Treatment as usual + additional sessions of EMDR	Behavioral: EMDR; EMDR is a protocolized, evidence-based treatment for PTSD. Here we use it to target addiction memory representations that elicit craving and may influence drinking behavior. The EMDR study protocol is based on the standard EMDR protocol and other EMDR approaches used in addiction.; Other Name: Eye Movement Desensitization and Reprocessing; Behavioral: Community Reinforcement Approach; CRA is based on behavioural therapy principles: Functional analysis; Communication skills; Problem-solving skills; Sobriety sampling; Social networking; Refusal of substances; Reinforcing activities; Relapse management; Medication monitoring; Other Name: CRA

Outcome Measures

Primary Outcome Measures :

1. Changes in number of heavy drinking days in the previous 30 days [ Time Frame: Changes in baseline number of heavy drinking days in the previous 30 days, at post-intervention, and 1 and 6 month follow-up ]
   Changes in patient-reported number of heavy drinking days (defined as days on which 5 or more standard drinks of alcohol were consumed during the previous 30 days, as assessed with the alcohol TimeLine FollowBack (TLFB) method).

Secondary Outcome Measures :

1. Time to first alcohol consumption [ Time Frame: Up to 6 months post-intervention ]
   Time to first alcohol consumption as measured by the alcohol Timeline FollowBack method (TLFB)
2. Changes in number of total drinks consumed in the previous 30 days [ Time Frame: Changes in baseline number of total drinks consumed in the previous 30 days, at post-intervention, and 1 and 6 month follow-up ]
   Changes in number of drinks consumed in the previous 30 days as measured by the alcohol TLFB
3. Changes in average drinks per occasion in the previous 30 days [ Time Frame: Changes in baseline average drinks per occasion in the previous 30 days, at post-intervention, and 1 and 6 month follow-up ]
   Changes in average drinks per occasion in the past 30 days as measured by the alcohol TLFB
4. Changes in severity of patient-reported problematic alcohol use [ Time Frame: Changes in baseline severity of patient-reported problematic alcohol use, at post-intervention, and 1 and 6 month follow-up ]
   Changes in severity of patient-reported problematic alcohol use during the previous month as measured by the Alcohol Use Disorders Identification Test (AUDIT)
5. Changes in biomarker levels [ Time Frame: Change from baseline assessment, at post-intervention, and follow-up after 1 and 6 months ]
   Changes in biomarker levels as measured by laboratory tests of serum γ-glutamyltransferase (GGT) and carbohydrate-deficient transferrin (CDT)
6. Changes in alcohol attentional bias [ Time Frame: Changes in baseline alcohol attentional bias, at post-intervention, and 1 and 6 month follow-up ]
   Changes in alcohol attentional bias as measured by the Alcohol Stroop
7. Changes in alcohol implicit associations [ Time Frame: Changes in baseline alcohol implicit associations, at post-intervention, and 1 and 6 month follow-up ]
   Changes in alcohol implicit associations as measured by the valence Implicit Association Task (IAT)
8. Changes in patient-reported craving [ Time Frame: Changes in baseline patient-reported craving, at post-intervention, and 1 and 6 month follow-up ]
   Changes in patient-reported craving as measured by the Penn Alcohol Craving Scale (PACS)
9. Changes in patient-reported desire thinking [ Time Frame: Changes in baseline patient-reported desire thinking, at post-intervention, and 1 and 6 month follow-up ]
   Changes in patient-reported desire thinking as measured by the Desire Thinking Questionnaire (DTQ)
10. Changes in patient-reported coping self-efficacy [ Time Frame: Changes in baseline patient-reported coping self-efficacy, at post-intervention, and 1 and 6 month follow-up ]
    Changes in patient-reported coping self-efficacy as measured by the Self-Efficacy List for Drug users (SELD)
11. Changes in patient-reported quality of life [ Time Frame: Changes in baseline patint-reported quality of life, at post-intervention, and 1 and 6 month follow-up ]
    Changes in patient-reported quality of life as measured by the EuroQol-5D (EQ-5D) and the Community Reinforcement Approach Happiness scale (CRA-HS)
12. Changes in patient-reported rumination [ Time Frame: Changes in baseline patient-reported rumination, at post-intervention, and 1 and 6 month follow-up ]
    Changes in patient-reported rumination as measured by the Perseverative Thinking Questionnaire (PTQ)
13. Changes in patient-reported positive and negative affect [ Time Frame: Changes in baseline patient-reported positive and negative affect, at post-intervention, and 1 and 6 month follow-up ]
    Changes in patient-reported positive and negative affect as measured by the (translated) International Positive And Negative Affect Scale short-form version (I-PANAS-SF)
14. Drop out [ Time Frame: Up to 6 months post-intervention ]
    Drop-out of study

Other Outcome Measures:

1. History of drinking and other substance use [ Time Frame: Baseline ]
   History of drinking and other substance use as measured by the Measurements in the Addictions for Triage and Evaluation (MATE)
2. Patient-reported motivation to stay abstinent [ Time Frame: Baseline ]
   Patient-reported motivation to stay abstinent as measured by the Readiness to Change Questionnaire, Dutch version (RCQ-D)
3. Psychiatric comorbidity [ Time Frame: Baseline ]
   Psychiatric comorbidity as measured by the Mini-International Neuropsychiatric Interview (MINI-plus)
4. Use of anti-craving, abstinence enforcing or other psychoactive medication [ Time Frame: At baseline, post-intervention and 1 and 6 month follow-up ]
   Use of anti-craving, abstinence enforcing or other psychoactive medication as derived from patient and patient dossier during assessments
5. Time-in-treatment: total time of TAU (at last assessment) [ Time Frame: Up to 6 months follow up ]
   Time-in-treatment defined by total time of TAU from start of regular treatment until 6 month follow up.
6. Intensity of treatment: number of treatment sessions [ Time Frame: Up until 6 months follow up ]
   Intensity of treatment: number of treatment sessions received from start of regular treatment until 6 months follow up
7. Contents of treatment received [ Time Frame: Up until 6 month follow up ]
   Treatment modules received that constitute TAU for a specific participant

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• A primary diagnosis of alcohol dependence or abuse (meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR criteria (American Psychiatric Association, 2000);
• Age of at least 18 years or older;
• Can speak and read Dutch language;
• Consent (written) to postponed information given.

Exclusion Criteria:

• Meeting the DSM-IV-TR (American Psychiatric Association, 2000) criteria for current (in the past 2 weeks) addiction and regular use (at least once per week in the last two weeks before baseline screening) of drugs other than alcohol or nicotine (relative exclusion: decision on case-by-case basis whether it leads to therapy-interference);
• Meeting the DSM-IV (American Psychiatric Association, 2000) criteria for current (in the last two weeks before baseline screening) regular alcohol use (at least > 21E (women) or > 28E (men) per week) (relative exclusion: decision on case-by-case basis) (relative exclusion: decision on case-by-case basis whether it leads to therapy-interference);
• Meeting the DSM-IV (American Psychiatric Association, 2000) criteria for current post-traumatic stress disorder (PTSD);
• Severe, current (since the start of regular treatment) psychiatric symptoms (especially manic, psychotic, suicidal and aggressive symptoms) that may endanger participants or others and jeopardize study adherence.

Contacts and Locations

Locations

Netherlands

IrisZorg

Arnhem, Gelderland, Netherlands, 6800 AJ

Sponsors and Collaborators

IrisZorg

Fonds Psychische Gezondheid

Dutch EMDR Association

EMDR Research Foundation

Investigators

• Principal Investigator: Wiebren Markus, MSc; IrisZorg, NISPA, BSI (Radboud University)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: W. Markus, MSc, IrisZorg
• ClinicalTrials.gov Identifier: NCT01828866 History of Changes
• Other Study ID Numbers: IZ / NISPA / BSI / WM04
• First Posted: April 11, 2013
• Last Update Posted: September 15, 2016
• Last Verified: September 2016

Keywords provided by W. Markus, IrisZorg:

EMDR; Alcohol; Relapse; Craving

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Ethanol; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs