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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]

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)

Condition category

Condition code

Mental Health

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]

Rehabilitation

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

Baseline (pre-treatment), post-treatment, and 3-months post-treatment.

Secondary outcome [1]

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]

Baseline (pre-treatment), post-treatment, and 3-months post-treatment.

Secondary outcome [2]

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]

Baseline (pre-treatment), post-treatment, and 3-months post-treatment.

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Murdoch University

Address [1]

90 South Street
Murdoch WA 6150

Country [1]

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]

Individual

Name [1]

Dr. Marjorie Collins

Address [1]

School of Psychology
90 South Street
Murdoch WA 6150

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Andrea Chong

Address [1]

23/6 Kintail Road
Applecross WA 6153

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

16/03/2012

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Eye Movement Desensitization and Reprocessing (EMDR) is a well-established first line psychological treatment for post-traumatic stress disorder.  In the addictions field, it has been suggested that clients presenting with addictions have a concomitant history of trauma, and comorbidity rates of up to 75%.  However, few studies to date have documented the use of EMDR in this area, and its efficacy as a treatment for addictions remains unclear and less well established in the literature.  In the utility of EMDR for the treatment of alcohol dependency, the limited research available has suggested promising results in reducing craving for alcohol.  The experience of craving for substances has been suggested by researchers to be one of the factors maintaining alcohol/drug use, as well as a precipitating factor for relapse.  Implications for establishing the efficacy of EMDR in addiction treatment therefore includes the potential to improve existing relapse prevention programs, and consequently to reduce relapse rates.  

The current study aims to examine and evaluate the application of EMDR in the treatment of individuals with substance dependence.  Specifically, the efficacy of an EMDR treatment that targets the experience of craving for substances will be investigated.  Research questions for the study are as follows:
1.  Is the application of EMDR in targeting craving effective as an adjunct to treatment for substance dependent individuals? 
2.  How does adding EMDR to a standardized treatment program for substance dependence compare to the:  
(a) addition of an active relapse prevention program (Mindfulness-based relapse prevention, MBRP)? and 
(b) addition of a program unassociated with craving and relapse prevention (cognitive rehabilitation)?

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Chris Lee

Address

Murdoch University - School of Psychology
90 South Street
Murdoch WA 6150

Country

Australia

Phone

+61 8 93606828

Fax

chris.lee@murdoch.edu.au

Contact person for scientific queries

Name

Dr. Chris Lee

Address

Murdoch University - School of Psychology
90 South Street
Murdoch WA 6150

Country

Australia

Phone

+61 8 93606828

Fax

chris.lee@murdoch.edu.au

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.

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