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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Behavioral: EMDR
* Behavioral: Community Reinforcement Approach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Community Reinforcement Approach<br>Treatment as usual, provided in out-patient setting | Behavioral: Community Reinforcement Approach<br>* 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<br>* Other names: CRA;|
| Experimental: Community Reinforcement Approach + EMDR<br>Treatment as usual + additional sessions of EMDR | Behavioral: EMDR<br>* 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.<br>* Other names: Eye Movement Desensitization and Reprocessing;Behavioral: Community Reinforcement Approach<br>* 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<br>* Other names: CRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in number of heavy drinking days in the previous 30 days | 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). | Changes in baseline number of heavy drinking days in the previous 30 days, at post-intervention, and 1 and 6 month follow-up | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMDR, Alcohol, Relapse, Craving