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)
Verified date | September 2016 |
Source | IrisZorg |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | IrisZorg | Arnhem | Gelderland |
Lead Sponsor | Collaborator |
---|---|
IrisZorg | Dutch EMDR Association, EMDR Research Foundation, Fonds Psychische Gezondheid |
Netherlands,
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 |
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