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Alcohol DependenceNCT01828866

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

A study testing EMDR and Community Reinforcement Approach in people with Alcohol Dependence, run by IrisZorg at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Dependence
What is being tested?
EMDR and Community Reinforcement Approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
1 siteNetherlands
Study dates
Sep 2013to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • IrisZorg

    Arnhem, Gelderland, 6800 AJ

Other trials in Netherlands

About this study

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)

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.

Being tested
EMDR, Community Reinforcement Approach
Keywords
EMDR, Alcohol, Relapse, Craving
Medical subject headings
Alcoholism, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMDRBehavioural

    Also called Eye Movement Desensitization and Reprocessing

    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.

  • Community Reinforcement ApproachBehavioural

    Also called CRA

    CRA is based on behavioural therapy principles:

    1. Functional analysis
    2. Communication skills
    3. Problem-solving skills
    4. Sobriety sampling
    5. Social networking
    6. Refusal of substances
    7. Reinforcing activities
    8. Relapse management
    9. Medication monitoring
Study groups in NCT01828866
Study groupRoleWhat they receive
Community Reinforcement ApproachActive comparatorTreatment as usual, provided in out-patient setting
Receives: Behavioral: Community Reinforcement Approach
Community Reinforcement Approach + EMDRExperimentalTreatment as usual + additional sessions of EMDR
Receives: Behavioral: EMDR; Behavioral: Community Reinforcement Approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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 (14)

  1. Time to first alcohol consumption

    Time to first alcohol consumption as measured by the alcohol Timeline FollowBack method (TLFB)

    Measured: Up to 6 months post-intervention

  2. 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

    Measured: Changes in baseline number of total drinks consumed in the previous 30 days, at post-intervention, and 1 and 6 month follow-up

  3. 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

    Measured: Changes in baseline average drinks per occasion in the previous 30 days, at post-intervention, and 1 and 6 month follow-up

  4. 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)

    Measured: Changes in baseline severity of patient-reported problematic alcohol use, at post-intervention, and 1 and 6 month follow-up

  5. Changes in biomarker levels

    Changes in biomarker levels as measured by laboratory tests of serum γ-glutamyltransferase (GGT) and carbohydrate-deficient transferrin (CDT)

    Measured: Change from baseline assessment, at post-intervention, and follow-up after 1 and 6 months

  6. Changes in alcohol attentional bias

    Changes in alcohol attentional bias as measured by the Alcohol Stroop

    Measured: Changes in baseline alcohol attentional bias, at post-intervention, and 1 and 6 month follow-up

  7. Changes in alcohol implicit associations

    Changes in alcohol implicit associations as measured by the valence Implicit Association Task (IAT)

    Measured: Changes in baseline alcohol implicit associations, at post-intervention, and 1 and 6 month follow-up

  8. Changes in patient-reported craving

    Changes in patient-reported craving as measured by the Penn Alcohol Craving Scale (PACS)

    Measured: Changes in baseline patient-reported craving, at post-intervention, and 1 and 6 month follow-up

  9. Changes in patient-reported desire thinking

    Changes in patient-reported desire thinking as measured by the Desire Thinking Questionnaire (DTQ)

    Measured: Changes in baseline patient-reported desire thinking, at post-intervention, and 1 and 6 month follow-up

  10. 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)

    Measured: Changes in baseline patient-reported coping self-efficacy, at post-intervention, and 1 and 6 month follow-up

  11. 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)

    Measured: Changes in baseline patint-reported quality of life, at post-intervention, and 1 and 6 month follow-up

  12. Changes in patient-reported rumination

    Changes in patient-reported rumination as measured by the Perseverative Thinking Questionnaire (PTQ)

    Measured: Changes in baseline patient-reported rumination, at post-intervention, and 1 and 6 month follow-up

  13. 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)

    Measured: Changes in baseline patient-reported positive and negative affect, at post-intervention, and 1 and 6 month follow-up

  14. Drop out

    Drop-out of study

    Measured: Up to 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01828866
Sponsor's protocol ID
IZ / NISPA / BSI / WM04
Status last verified
Sep 2016
First submitted
2 Apr 2013
Last updated
15 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25884223

Questions about this trial

What is this clinical trial studying?

A study testing EMDR and Community Reinforcement Approach in people with Alcohol Dependence, run by IrisZorg at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01828866, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.

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