- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01828866
Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Arnhem, Gelderland, Netherlands, 6800 AJ
- IrisZorg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Community Reinforcement Approach
Treatment as usual, provided in out-patient setting
|
CRA is based on behavioural therapy principles:
Other Names:
|
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Experimental: Community Reinforcement Approach + EMDR
Treatment as usual + additional sessions of EMDR
|
CRA is based on behavioural therapy principles:
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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 Frame: Up to 6 months post-intervention
|
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
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
|
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
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
|
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
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)
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Changes in baseline severity of patient-reported problematic alcohol use, at post-intervention, and 1 and 6 month follow-up
|
|
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)
|
Change from baseline assessment, at post-intervention, and follow-up after 1 and 6 months
|
|
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
|
Changes in baseline alcohol attentional bias, at post-intervention, and 1 and 6 month follow-up
|
|
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)
|
Changes in baseline alcohol implicit associations, at post-intervention, and 1 and 6 month follow-up
|
|
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)
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Changes in baseline patient-reported craving, at post-intervention, and 1 and 6 month follow-up
|
|
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)
|
Changes in baseline patient-reported desire thinking, at post-intervention, and 1 and 6 month follow-up
|
|
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)
|
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
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)
|
Changes in baseline patint-reported quality of life, at post-intervention, and 1 and 6 month follow-up
|
|
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)
|
Changes in baseline patient-reported rumination, at post-intervention, and 1 and 6 month follow-up
|
|
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)
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Changes in baseline patient-reported positive and negative affect, at post-intervention, and 1 and 6 month follow-up
|
|
Drop out
Time Frame: Up to 6 months post-intervention
|
Drop-out of study
|
Up to 6 months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Baseline
|
|
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)
|
Baseline
|
|
Psychiatric comorbidity
Time Frame: Baseline
|
Psychiatric comorbidity as measured by the Mini-International Neuropsychiatric Interview (MINI-plus)
|
Baseline
|
|
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
|
At baseline, post-intervention and 1 and 6 month follow-up
|
|
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.
|
Up to 6 months follow up
|
|
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
|
Up until 6 months follow up
|
|
Contents of treatment received
Time Frame: Up until 6 month follow up
|
Treatment modules received that constitute TAU for a specific participant
|
Up until 6 month follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wiebren Markus, MSc, IrisZorg, NISPA, BSI (Radboud University)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IZ / NISPA / BSI / WM04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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