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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
EMDR
Community Reinforcement Approach
Sponsored by
IrisZorg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring EMDR, Alcohol, Relapse, Craving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IrisZorg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Community Reinforcement Approach

Community Reinforcement Approach + EMDR

Arm Description

Treatment as usual, provided in out-patient setting

Treatment as usual + additional sessions of EMDR

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Time to first alcohol consumption
Time to first alcohol consumption as measured by the alcohol Timeline FollowBack method (TLFB)
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
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
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)
Changes in biomarker levels
Changes in biomarker levels as measured by laboratory tests of serum γ-glutamyltransferase (GGT) and carbohydrate-deficient transferrin (CDT)
Changes in alcohol attentional bias
Changes in alcohol attentional bias as measured by the Alcohol Stroop
Changes in alcohol implicit associations
Changes in alcohol implicit associations as measured by the valence Implicit Association Task (IAT)
Changes in patient-reported craving
Changes in patient-reported craving as measured by the Penn Alcohol Craving Scale (PACS)
Changes in patient-reported desire thinking
Changes in patient-reported desire thinking as measured by the Desire Thinking Questionnaire (DTQ)
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)
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)
Changes in patient-reported rumination
Changes in patient-reported rumination as measured by the Perseverative Thinking Questionnaire (PTQ)
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)
Drop out
Drop-out of study

Full Information

First Posted
April 2, 2013
Last Updated
September 14, 2016
Sponsor
IrisZorg
Collaborators
Fonds Psychische Gezondheid, Dutch EMDR Association, EMDR Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01828866
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IrisZorg
Collaborators
Fonds Psychische Gezondheid, Dutch EMDR Association, EMDR Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
EMDR, Alcohol, Relapse, Craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Reinforcement Approach
Arm Type
Active Comparator
Arm Description
Treatment as usual, provided in out-patient setting
Arm Title
Community Reinforcement Approach + EMDR
Arm Type
Experimental
Arm Description
Treatment as usual + additional sessions of EMDR
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Other Intervention Name(s)
Eye Movement Desensitization and Reprocessing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Reinforcement Approach
Other Intervention Name(s)
CRA
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in number of heavy drinking days in the previous 30 days
Description
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).
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
Secondary Outcome Measure Information:
Title
Time to first alcohol consumption
Description
Time to first alcohol consumption as measured by the alcohol Timeline FollowBack method (TLFB)
Time Frame
Up to 6 months post-intervention
Title
Changes in number of total drinks consumed in the previous 30 days
Description
Changes in number of drinks consumed in the previous 30 days as measured by the alcohol TLFB
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
Title
Changes in average drinks per occasion in the previous 30 days
Description
Changes in average drinks per occasion in the past 30 days as measured by the alcohol TLFB
Time Frame
Changes in baseline average drinks per occasion in the previous 30 days, at post-intervention, and 1 and 6 month follow-up
Title
Changes in severity of patient-reported problematic alcohol use
Description
Changes in severity of patient-reported problematic alcohol use during the previous month as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame
Changes in baseline severity of patient-reported problematic alcohol use, at post-intervention, and 1 and 6 month follow-up
Title
Changes in biomarker levels
Description
Changes in biomarker levels as measured by laboratory tests of serum γ-glutamyltransferase (GGT) and carbohydrate-deficient transferrin (CDT)
Time Frame
Change from baseline assessment, at post-intervention, and follow-up after 1 and 6 months
Title
Changes in alcohol attentional bias
Description
Changes in alcohol attentional bias as measured by the Alcohol Stroop
Time Frame
Changes in baseline alcohol attentional bias, at post-intervention, and 1 and 6 month follow-up
Title
Changes in alcohol implicit associations
Description
Changes in alcohol implicit associations as measured by the valence Implicit Association Task (IAT)
Time Frame
Changes in baseline alcohol implicit associations, at post-intervention, and 1 and 6 month follow-up
Title
Changes in patient-reported craving
Description
Changes in patient-reported craving as measured by the Penn Alcohol Craving Scale (PACS)
Time Frame
Changes in baseline patient-reported craving, at post-intervention, and 1 and 6 month follow-up
Title
Changes in patient-reported desire thinking
Description
Changes in patient-reported desire thinking as measured by the Desire Thinking Questionnaire (DTQ)
Time Frame
Changes in baseline patient-reported desire thinking, at post-intervention, and 1 and 6 month follow-up
Title
Changes in patient-reported coping self-efficacy
Description
Changes in patient-reported coping self-efficacy as measured by the Self-Efficacy List for Drug users (SELD)
Time Frame
Changes in baseline patient-reported coping self-efficacy, at post-intervention, and 1 and 6 month follow-up
Title
Changes in patient-reported quality of life
Description
Changes in patient-reported quality of life as measured by the EuroQol-5D (EQ-5D) and the Community Reinforcement Approach Happiness scale (CRA-HS)
Time Frame
Changes in baseline patint-reported quality of life, at post-intervention, and 1 and 6 month follow-up
Title
Changes in patient-reported rumination
Description
Changes in patient-reported rumination as measured by the Perseverative Thinking Questionnaire (PTQ)
Time Frame
Changes in baseline patient-reported rumination, at post-intervention, and 1 and 6 month follow-up
Title
Changes in patient-reported positive and negative affect
Description
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)
Time Frame
Changes in baseline patient-reported positive and negative affect, at post-intervention, and 1 and 6 month follow-up
Title
Drop out
Description
Drop-out of study
Time Frame
Up to 6 months post-intervention
Other Pre-specified Outcome Measures:
Title
History of drinking and other substance use
Description
History of drinking and other substance use as measured by the Measurements in the Addictions for Triage and Evaluation (MATE)
Time Frame
Baseline
Title
Patient-reported motivation to stay abstinent
Description
Patient-reported motivation to stay abstinent as measured by the Readiness to Change Questionnaire, Dutch version (RCQ-D)
Time Frame
Baseline
Title
Psychiatric comorbidity
Description
Psychiatric comorbidity as measured by the Mini-International Neuropsychiatric Interview (MINI-plus)
Time Frame
Baseline
Title
Use of anti-craving, abstinence enforcing or other psychoactive medication
Description
Use of anti-craving, abstinence enforcing or other psychoactive medication as derived from patient and patient dossier during assessments
Time Frame
At baseline, post-intervention and 1 and 6 month follow-up
Title
Time-in-treatment: total time of TAU (at last assessment)
Description
Time-in-treatment defined by total time of TAU from start of regular treatment until 6 month follow up.
Time Frame
Up to 6 months follow up
Title
Intensity of treatment: number of treatment sessions
Description
Intensity of treatment: number of treatment sessions received from start of regular treatment until 6 months follow up
Time Frame
Up until 6 months follow up
Title
Contents of treatment received
Description
Treatment modules received that constitute TAU for a specific participant
Time Frame
Up until 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wiebren Markus, MSc
Organizational Affiliation
IrisZorg, NISPA, BSI (Radboud University)
Official's Role
Principal Investigator
Facility Information:
Facility Name
IrisZorg
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800 AJ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25884223
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.
Results Reference
derived

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

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