NCT01828866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

April 2, 2013

Last Update Submit

September 14, 2016

Conditions

Keywords

EMDRAlcoholRelapseCraving

Outcome Measures

Primary Outcomes (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).

    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)

  • Time to first alcohol consumption

    Up to 6 months post-intervention

  • Changes in number of total drinks consumed in the previous 30 days

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

  • Changes in biomarker levels

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

  • +9 more secondary outcomes

Other Outcomes (7)

  • History of drinking and other substance use

    Baseline

  • Patient-reported motivation to stay abstinent

    Baseline

  • Psychiatric comorbidity

    Baseline

  • +4 more other outcomes

Study Arms (2)

Community Reinforcement Approach

ACTIVE COMPARATOR

Treatment as usual, provided in out-patient setting

Behavioral: Community Reinforcement Approach

Community Reinforcement Approach + EMDR

EXPERIMENTAL

Treatment as usual + additional sessions of EMDR

Behavioral: EMDRBehavioral: Community Reinforcement Approach

Interventions

EMDRBEHAVIORAL

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.

Also known as: Eye Movement Desensitization and Reprocessing
Community Reinforcement Approach + EMDR

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

Also known as: CRA
Community Reinforcement ApproachCommunity Reinforcement Approach + EMDR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IrisZorg

Arnhem, Gelderland, 6800 AJ, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AlcoholismRecurrence

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Wiebren Markus, MSc

    IrisZorg, NISPA, BSI (Radboud University)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 11, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations