Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000248864
Ethics application status
Not yet submitted
Date submitted
27/02/2012
Date registered
28/02/2012
Date last updated
28/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Eye Movement Desensitization Reprocessing (EMDR) to reduce craving in the treatment of substance dependency
Scientific title
Comparing the efficacy of Eye Movement Desensitization Reprocessing (EMDR) and Mindfulness-Based Relapse Prevention (MBRP) to reduce craving for substances in individuals with substance dependency
Secondary ID [1] 280039 0
Nil
Universal Trial Number (UTN)
U1111-1128-5388
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Craving for alcohol or illicit drugs (substance dependency) 285953 0
Condition category
Condition code
Mental Health 286140 286140 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye Movement Desensitization Reprocessing (EMDR) - EMDR is a form of psychotherapy that was developed by Francine Shapiro to resolve the development of trauma-related disorders caused by exposure to distressing events. The theory suggests that when distressing experiences occur they may overwhelm usual cognitive and neurological coping mechanisms. The memory and associated stimuli of the event are inadequately processed, and are dysfunctionally stored in an isolated memory network. The goal of EMDR therapy is to process these distressing memories, using dual attention stimuli (by way of bilateral stimulation e.g. eye movements, tones, or tapping), while triggering a physiological state that facilitates information processing, therefore reducing the distress and allowing clients to develop more adaptive coping mechanisms.

Duration of EMDR: 3 x 75min sessions over 2 or 3 consecutive weeks

Method of administration: one-on-one sessions with a clinician
Intervention code [1] 284362 0
Rehabilitation
Intervention code [2] 284367 0
Behaviour
Intervention code [3] 284368 0
Treatment: Other
Comparator / control treatment
Comparator (active) treatment: Mindfulness-Based Relapse Prevention (MBRP) - MBRP is a treatment approach developed at the Addictive Behaviors Research Center (University of Washington) for individuals in recovery for addictive behaviors. It integrates mindfulness meditation practices with traditional relapse prevention strategies. The program is designed specifically to help prevent or manage relapse for clients with alcohol and other substsance use problems through practices that foster increased awareness of triggers, habitual patterns, and automatic reactions.

Duration of MBRP: 3 x 75min sessions over 2 or 3 consecutive weeks

Method of administration: one-on-one sessions with a clinician


Placebo (control) treatment: Cognitive training to improve memory, attention, executive functioning, and problem solving skills.

Duration of cognitive training: 3 x 75min sessions over 2 or 3 consecutive weeks

Method of administration: one-on-one sessions with a clinician
Control group
Placebo

Outcomes
Primary outcome [1] 286613 0
The primary measure of effectiveness is a statistically significant (p<.001) reduction in self-reported craving for alcohol and/or illicit drugs.

Instrument: Approach & Avoidance of Alcohol Questionnaire-Revised (AAAQ-R) - THe AAAQ-R is a 16-item self report measure that separately assesses inclinations to consume and to not consume substances.
Timepoint [1] 286613 0
Baseline (pre-treatment), post-treatment, and 3-months post-treatment.
Secondary outcome [1] 296272 0
Secondary outcome 1: Mindful awareness as assessed on the Freiburg Mindfulness Inventory (FMI), a 14-item self report assessment of the general construct of mindfulness.
Timepoint [1] 296272 0
Baseline (pre-treatment), post-treatment, and 3-months post-treatment.
Secondary outcome [2] 296273 0
Secondary outcome 2: Coping strategies utilized to avoid or to control drinking/drugging, as assessed on the Coping Behaviors Inventory (CBI), a 36-item self report tool.
Timepoint [2] 296273 0
Baseline (pre-treatment), post-treatment, and 3-months post-treatment.
Secondary outcome [3] 296274 0
Secondary outcome 3: Perceived confidence to abstain from alcohol and/or drug use in different situations, as assessed on the Alcohol Abstinence Self-Efficacy Scale - Alcohol and Drug versions (AASES/DASES). This is a 20-item self evaluation tool.
Timepoint [3] 296274 0
Baseline (pre-treatment), post-treatment, and 3-months post-treatment.

Eligibility
Key inclusion criteria
1. Participants must meet DSM-IV or ICD-10 diagnostic criteria for substance dependence

2. Willing to be contacted for follow-up
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of traumatic brain injury

2. Presence of organic brain disorders

3. On-going use of any substances

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve treatment administrators contacting the holder of the allocation schedule who is off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using computerized sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284796 0
University
Name [1] 284796 0
Murdoch University
Country [1] 284796 0
Australia
Primary sponsor type
Individual
Name
Dr. Chris Lee
Address
School of Psychology
90 South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 283679 0
Individual
Name [1] 283679 0
Dr. Marjorie Collins
Address [1] 283679 0
School of Psychology
90 South Street
Murdoch WA 6150
Country [1] 283679 0
Australia
Other collaborator category [1] 260573 0
Individual
Name [1] 260573 0
Andrea Chong
Address [1] 260573 0
23/6 Kintail Road
Applecross WA 6153
Country [1] 260573 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286783 0
Ethics committee address [1] 286783 0
Ethics committee country [1] 286783 0
Date submitted for ethics approval [1] 286783 0
16/03/2012
Approval date [1] 286783 0
Ethics approval number [1] 286783 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33843 0
Address 33843 0
Country 33843 0
Phone 33843 0
Fax 33843 0
Email 33843 0
Contact person for public queries
Name 17090 0
Dr. Chris Lee
Address 17090 0
Murdoch University - School of Psychology
90 South Street
Murdoch WA 6150
Country 17090 0
Australia
Phone 17090 0
+61 8 93606828
Fax 17090 0
Email 17090 0
[email protected]
Contact person for scientific queries
Name 8018 0
Dr. Chris Lee
Address 8018 0
Murdoch University - School of Psychology
90 South Street
Murdoch WA 6150
Country 8018 0
Australia
Phone 8018 0
+61 8 93606828
Fax 8018 0
Email 8018 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.