Clinical trial NCT01828866: Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: EMDR
Alcohol
Relapse
Craving
Lead sponsor: IrisZorg
Sponsor class: OTHER
Collaborators: name: Fonds Psychische Gezondheid
name: Dutch EMDR Association
name: EMDR Research Foundation
First posted: 2013-04-11
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Changes in number of heavy drinking days in the previous 30 days
timeFrame: Changes in baseline number of heavy drinking days in the previous 30 days, at post-intervention, and 1 and 6 month follow-up
Secondary outcomes:
measure: Time to first alcohol consumption
timeFrame: Up to 6 months post-intervention
measure: Changes in number of total drinks consumed in the previous 30 days
timeFrame: Changes in baseline number of total drinks consumed in the previous 30 days, at post-intervention, and 1 and 6 month follow-up
measure: Changes in average drinks per occasion in the previous 30 days
timeFrame: Changes in baseline average drinks per occasion in the previous 30 days, at post-intervention, and 1 and 6 month follow-up
measure: Changes in severity of patient-reported problematic alcohol use
timeFrame: Changes in baseline severity of patient-reported problematic alcohol use, at post-intervention, and 1 and 6 month follow-up
measure: Changes in biomarker levels
timeFrame: Change from baseline assessment, at post-intervention, and follow-up after 1 and 6 months
measure: Changes in alcohol attentional bias
timeFrame: Changes in baseline alcohol attentional bias, at post-intervention, and 1 and 6 month follow-up
measure: Changes in alcohol implicit associations
timeFrame: Changes in baseline alcohol implicit associations, at post-intervention, and 1 and 6 month follow-up
measure: Changes in patient-reported craving
timeFrame: Changes in baseline patient-reported craving, at post-intervention, and 1 and 6 month follow-up
measure: Changes in patient-reported desire thinking
timeFrame: Changes in baseline patient-reported desire thinking, at post-intervention, and 1 and 6 month follow-up
measure: Changes in patient-reported coping self-efficacy
timeFrame: Changes in baseline patient-reported coping self-efficacy, at post-intervention, and 1 and 6 month follow-up
measure: Changes in patient-reported quality of life
timeFrame: Changes in baseline patint-reported quality of life, at post-intervention, and 1 and 6 month follow-up
measure: Changes in patient-reported rumination
timeFrame: Changes in baseline patient-reported rumination, at post-intervention, and 1 and 6 month follow-up
measure: Changes in patient-reported positive and negative affect
timeFrame: Changes in baseline patient-reported positive and negative affect, at post-intervention, and 1 and 6 month follow-up
measure: Drop out
timeFrame: Up to 6 months post-intervention
Other outcomes:
measure: History of drinking and other substance use
timeFrame: Baseline
measure: Patient-reported motivation to stay abstinent
timeFrame: Baseline
measure: Psychiatric comorbidity
timeFrame: Baseline
measure: Use of anti-craving, abstinence enforcing or other psychoactive medication
timeFrame: At baseline, post-intervention and 1 and 6 month follow-up
measure: Time-in-treatment: total time of TAU (at last assessment)
timeFrame: Up to 6 months follow up
measure: Intensity of treatment: number of treatment sessions
timeFrame: Up until 6 months follow up
measure: Contents of treatment received
timeFrame: Up until 6 month follow up
Locations:
city: Arnhem
country: Netherlands
facility: IrisZorg
state: Gelderland
Study officials:
affiliation: IrisZorg, NISPA, BSI (Radboud University)
name: Wiebren Markus, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.