This proposal consists of two studies to test and determine the acceptability, feasibility and preliminary efficacy of EMDR as an intervention to reduce craving and alcohol use in alcohol dependent outpatients as well as to gain further…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
alcohol afhankelijkheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Multiple baseline study:
• Changes in number of total drinks consumed since last assessment as measured
by a patient-kept daily diary;
RCT:
• Changes in heavy drinking days (defined as consuming >=5 alcohol drinks on a
given day) in the past 30 days as measured by the alcohol
Timeline Followback (TLFB; Sobell & Sobell, 1992);
Secondary outcome
Multiple baseline study:
• Changes in patient-reported craving as measured by the Penn Alcohol Craving
Scale (PACS; Flannery, Volpicelli, & Pettinati, 1999);
• 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; Thompson, 2007);
• Changes in severity of patient-reported problematic alcohol use during the
previous month as measured by the Alcohol Use Disorders I
Identification Test (AUDIT; Saunders, Aasland, Babor, de la Fuente, &
Grant, 1993; Dutch translation: Schippers & Broekman, 2010);
• Changes in patient-reported desire thinking as measured by the Desire
Thinking Questionnaire (DTQ; Caselli & Spada, 2011; Dutch
version);
• Changes in patient-reported coping self-efficacy as measured by the
Self-Efficacy List for Drug users (SELD; De Weert-Van Oene, Breteler,
Schippers, & Schrijvers, 2000);
• Changes in patient-reported quality of life as measured by the EuroQol-5D
(EQ-5D; The EuroQol group, 1996) and the Community
Reinforcement Approach Happiness scale (CRA-HS; Meyers & Smith, 1995);
• Changes in patient-reported rumination as measured by the Perseverative
Thinking Questionnaire (PTQ; Ehring, Zetsche, Weidacker,
Wahl, Schönfeld, & Ehlers, 2011);
• Changes in alcohol attentional bias as measured by the Alcohol Stroop
(Stroop, 1935; Williams, Mathews, & MacLeod; 1996);
• Changes in alcohol implicit associations as measured by the Drinking Identity
IAT (Lindgren, Neighbors, Teachman, Wiers, Westgate, &
Greenwald, 2012).
RCT:
• Time to first alcohol consumption (post-intervention) as measured by the
alcohol TLFB;
• Changes in number of total drinks consumed in the past 30 days as measured by
the alcohol TLFB;
• 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 during the
previous month as measured by the AUDIT;
• Changes in biomarker levels as measured by laboratory tests of serum γ-
glutamyltransferase (GGT) and carbohydrate-deficient transferrin
(CDT);
• Changes in alcohol attentional bias as measured by the Alcohol Stroop;
• Changes in alcohol implicit associations as measured by the Drinking Identity
IAT;
• Changes in patient-reported craving as measured by the PACS;
• Changes in patient-reported desire thinking as measured by the DTQ;
• Changes in patient-reported coping self-efficacy as measured by the SELD;
• Changes in patient-reported quality of life as measured by the EQ-5D and the
CRA-HS;
• Changes in patient-reported rumination as measured by the PTQ;
• Changes in patient-reported positive and negative affect as measured by the
(translated) I-PANAS-SF;
• Differential drop-out in EMDR + TAU and TAU only group.
Background 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.
Study objective
This proposal consists of two studies to test and determine the acceptability,
feasibility and preliminary 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
Study design
The first study has the form of a (non-concurrent) multiple baseline study
across subjects (3 alcohol-dependent out-patients) with a follow up period of 1
month.
The second study has the form of a pilot randomized controlled trail (RCT)
with out-patient alcohol-dependent patients (n=100) with 2 (parallel) groups
and repeated measures amounting to a 2 x 4 between participants design with
group (EMDR + treatment as usual (TAU) vs. TAU) and time of assessment (pre- x
post-intervention x 1 month x 6 months follow up) as factors. The allocation
ratio is 1 : 1 for the 2 groups. Both participants and research assistants (who
carry out assessments) will be blinded to group assignment while therapists
will be blinded to outcome of assessments. The principal investigator will be
blinded to group assignment until data analysis is finished.
Intervention
Participants of the multiple baseline study and those assigned to the
experimental group of the RCT receive EMDR (aimed at drinking behaviour and
craving) + TAU. EMDR is a protocolized treatment for posttraumatic stress
disorder (PTSD) (Shapiro, 2007). Hase, Schallmayer and Sack (2008) demonstrated
its potential in relapse prevention of alcohol-dependent patients. EMDR is
provided by trained EMDR therapists.
TAU is Community Reinforcement Approach (CRA) treatment, consisting of several
interventions, based on behavioural therapy principles (Meyers & Smith, 1995).
Study burden and risks
Participants complete questionnaires and computer tasks and give blood samples
at specified intervals. Benefits for participants of the multiple baseline
study and experimental group of the RCT are that they receive additional
treatment which may help to resist urges and prevent the reinitiation or
escalation of drinking behaviour. All participants receive an incentive (a
voucher worth ¤ 25) after each follow-up assessment to reduce loss-to-follow-up.
Participants who receive EMDR are instructed to recall memories which, at
first, elicit craving for alcohol. This may cause some inconvenience during
sessions but clinical experience thus far suggests that this is well tolerated.
Kronenburgsingel 545
Arnhem 6831 GM
NL
Kronenburgsingel 545
Arnhem 6831 GM
NL
Listed location countries
Age
Inclusion criteria
Age: 18 years or older
Primary diagnosis of alcohol dependence
Exclusion criteria
Severe, current (since intake) psychiatric symptoms (e.g. suicidality, mania, psychosis, agression)
Current, co-morbid PTSD
Recent (last 2 weeks before baseline screening) regular (once or more/week) cannabis or harddrug use
Recent (last 2 weeks before baseline screening) regular alcohol use (> 21E (women) or > 28E (men)/week)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT01828866 |
CCMO | NL43892.044.13 |