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Completed

NCT Number: NCT01828866

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IrisZorg

Arnhem, Gelderland, 6800 AJ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMDR

Behavioral

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: Eye Movement Desensitization and Reprocessing

Community Reinforcement Approach

Behavioral

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 names: CRA

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

IrisZorg

Other

Collaborators

  • Dutch EMDR Association
  • EMDR Research Foundation
  • Fonds Psychische Gezondheid

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2013
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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