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

Alcohol Dependence Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828866
• Other study ID #: IZ / NISPA / BSI / WM04
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: September 14, 2016
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: IrisZorg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• EMDR
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 Approach
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

Locations

Country	Name	City	State
Netherlands	IrisZorg	Arnhem	Gelderland

Sponsors (4)

Lead Sponsor	Collaborator
IrisZorg	Dutch EMDR Association, EMDR Research Foundation, Fonds Psychische Gezondheid

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	History of drinking and other substance use	History of drinking and other substance use as measured by the Measurements in the Addictions for Triage and Evaluation (MATE)	Baseline	No
Other	Patient-reported motivation to stay abstinent	Patient-reported motivation to stay abstinent as measured by the Readiness to Change Questionnaire, Dutch version (RCQ-D)	Baseline	No
Other	Psychiatric comorbidity	Psychiatric comorbidity as measured by the Mini-International Neuropsychiatric Interview (MINI-plus)	Baseline	No
Other	Use of anti-craving, abstinence enforcing or other psychoactive medication	Use of anti-craving, abstinence enforcing or other psychoactive medication as derived from patient and patient dossier during assessments	At baseline, post-intervention and 1 and 6 month follow-up	No
Other	Time-in-treatment: total time of TAU (at last assessment)	Time-in-treatment defined by total time of TAU from start of regular treatment until 6 month follow up.	Up to 6 months follow up	No
Other	Intensity of treatment: number of treatment sessions	Intensity of treatment: number of treatment sessions received from start of regular treatment until 6 months follow up	Up until 6 months follow up	No
Other	Contents of treatment received	Treatment modules received that constitute TAU for a specific participant	Up until 6 month follow up	No
Primary	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	No
Secondary	Time to first alcohol consumption	Time to first alcohol consumption as measured by the alcohol Timeline FollowBack method (TLFB)	Up to 6 months post-intervention	No
Secondary	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 baseline number of total drinks consumed in the previous 30 days, at post-intervention, and 1 and 6 month follow-up	No
Secondary	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 baseline average drinks per occasion in the previous 30 days, at post-intervention, and 1 and 6 month follow-up	No
Secondary	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 baseline severity of patient-reported problematic alcohol use, at post-intervention, and 1 and 6 month follow-up	No
Secondary	Changes in biomarker levels	Changes in biomarker levels as measured by laboratory tests of serum ?-glutamyltransferase (GGT) and carbohydrate-deficient transferrin (CDT)	Change from baseline assessment, at post-intervention, and follow-up after 1 and 6 months	No
Secondary	Changes in alcohol attentional bias	Changes in alcohol attentional bias as measured by the Alcohol Stroop	Changes in baseline alcohol attentional bias, at post-intervention, and 1 and 6 month follow-up	No
Secondary	Changes in alcohol implicit associations	Changes in alcohol implicit associations as measured by the valence Implicit Association Task (IAT)	Changes in baseline alcohol implicit associations, at post-intervention, and 1 and 6 month follow-up	No
Secondary	Changes in patient-reported craving	Changes in patient-reported craving as measured by the Penn Alcohol Craving Scale (PACS)	Changes in baseline patient-reported craving, at post-intervention, and 1 and 6 month follow-up	No
Secondary	Changes in patient-reported desire thinking	Changes in patient-reported desire thinking as measured by the Desire Thinking Questionnaire (DTQ)	Changes in baseline patient-reported desire thinking, at post-intervention, and 1 and 6 month follow-up	No
Secondary	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 baseline patient-reported coping self-efficacy, at post-intervention, and 1 and 6 month follow-up	No
Secondary	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 baseline patint-reported quality of life, at post-intervention, and 1 and 6 month follow-up	No
Secondary	Changes in patient-reported rumination	Changes in patient-reported rumination as measured by the Perseverative Thinking Questionnaire (PTQ)	Changes in baseline patient-reported rumination, at post-intervention, and 1 and 6 month follow-up	No
Secondary	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)	Changes in baseline patient-reported positive and negative affect, at post-intervention, and 1 and 6 month follow-up	No
Secondary	Drop out	Drop-out of study	Up to 6 months post-intervention	No