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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02634476




Registration number
NCT02634476
Ethics application status
Date submitted
16/10/2015
Date registered
18/12/2015
Date last updated
25/10/2016

Titles & IDs
Public title
Can Cognitive-bias Modification Training During Inpatient Alcohol Detoxification Reduce Relapse Rates Post-discharge?
Scientific title
Can Cognitive-bias Modification Training During Inpatient Alcohol Detoxification Reduce Relapse Rates Post-discharge?
Secondary ID [1] 0 0
E33-1314
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Alcohol approach/avoidance task
BEHAVIORAL - Sham approach/avoidance task

Experimental: cognitive bias modification training - Participants complete four sessions of the alcohol approach/avoidance task.

Sham comparator: sham training - Participants complete four sessions of the sham approach/avoidance task.


BEHAVIORAL: Alcohol approach/avoidance task
The approach-bias modification is a computerised alcohol approach/avoidance task (alcohol-AAT) in which participants are instructed to respond with an approach movement (pulling a joystick) to pictures in landscape orientation and an avoidance movement (pushing a joystick) to pictures in portrait orientation. The size of the image is increased and decreased by pulling and pushing the joystick respectively, generating a sensation of approach or avoidance. Pictures include images of 20 alcoholic and 20 non-alcoholic drinks presented in a fixed orientation such that participants are in effect instructed to respond to pictures of alcohol by making an avoidance movement (pushing the joystick) and to pictures of non-alcoholic soft drinks by making an approach movement (pulling the joystick).

BEHAVIORAL: Sham approach/avoidance task
The computerised training for the sham condition is the same as for the experimental condition, except that in the sham approach/avoidance task, both landscape and portrait pictures all contain neutral (non-alcohol related).
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Alcohol abstinence
Timepoint [1] 0 0
2-week follow-up
Secondary outcome [1] 0 0
Days until relapse
Timepoint [1] 0 0
2-week follow-up
Secondary outcome [2] 0 0
Number of heavy drinking days
Timepoint [2] 0 0
2-week follow-up
Secondary outcome [3] 0 0
Alcohol craving
Timepoint [3] 0 0
Immediately after the 4th training session (days 6 or 7 following admission)
Secondary outcome [4] 0 0
Alcohol craving
Timepoint [4] 0 0
2-week follow-up
Secondary outcome [5] 0 0
Abstinence at 3-months
Timepoint [5] 0 0
3-month follow-up
Secondary outcome [6] 0 0
Decision-making
Timepoint [6] 0 0
Immediately after the 4th training session (days 6 or 7 following admission)

Eligibility
Key inclusion criteria
* At least weekly use of alcohol in the past month.
* Meet Diagnostic and Statistical Manual (DSM) criteria for alcohol use disorder
* Currently in treatment for alcohol withdrawal
* Able to understand English
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Meet Diagnostic and Statistical Manual (DSM) criteria for a psychotic illness
* History of neurological illness
* History of brain injury involving loss of consciousness for >30 minutes
* Intellectual disability

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Wellington House - Box Hill
Recruitment postcode(s) [1] 0 0
3128 - Box Hill

Funding & Sponsors
Primary sponsor type
Other
Name
Turning Point
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Deakin University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
It is well-established that many substance misusers experience impairment in cognition (thinking skills), particularly those needed to regulate and monitor behaviour and ensure that goals are achieved. According to the dual-process model, addiction arises from an imbalance in 'bottom-up' processing i.e., overactive automatic (impulsive) processes that drive behaviours and impaired 'top-down' controlling processes that stop behaviours associated with negative consequences. As a result, the individual becomes more sensitive to cues in their environment (e.g., alcohol images) that trigger the addictive behaviour. Cognitive-bias modification (CBM) is a novel, computer-based training paradigm that trains the brain to pay less attention to negative/harmful cues and more attention to positive or neutral cues. This approach minimizes the overactive 'bottom-up' processes and improves the 'top-down' control processes of unhealthy behaviors which enables the addicted individual to make better decisions. Recently, CBM has been used with addicted population to alter the tendency to approach alcohol, with one German study showing that a 4-session training programme was associated higher rates of abstinence at one-year (Wiers et al., 2011). The current study examines whether a novel computer based training programme alters cognitive biases (the tendency to approach alcohol related stimuli) in alcohol-dependent inpatients, and examine whether this enables them to be better at decision-making more generally, and its impact on craving and post-discharge abstinence rates. The study will also explore whether individual differences in impulsivity and sensitivity to reward and punishment determine response to the training programme. This will be achieved using a parallel-groups randomized superiority trial design involving approximately 80 patients attending inpatient withdrawal programmes in Victoria. The findings are likely to have implications for the design and delivery of psychosocial interventions delivered during early recovery from alcohol-dependence to optimise treatment effectiveness.
Trial website
https://clinicaltrials.gov/study/NCT02634476
Trial related presentations / publications
Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Implementation of approach bias re-training in alcoholism-how many sessions are needed? Alcohol Clin Exp Res. 2014 Feb;38(2):587-94. doi: 10.1111/acer.12281. Epub 2013 Oct 24.
Gladwin TE, Figner B, Crone EA, Wiers RW. Addiction, adolescence, and the integration of control and motivation. Dev Cogn Neurosci. 2011 Oct;1(4):364-76. doi: 10.1016/j.dcn.2011.06.008. Epub 2011 Jul 2.
Bechara A, Tranel D, Damasio H. Characterization of the decision-making deficit of patients with ventromedial prefrontal cortex lesions. Brain. 2000 Nov;123 ( Pt 11):2189-202. doi: 10.1093/brain/123.11.2189. Erratum In: Brain. 2009 Jul;132(Pt 7):1993.
Dawe S, Gray JA. Craving and drug reward: a comparison of methadone and clonidine in detoxifying opiate addicts. Drug Alcohol Depend. 1995 Oct;39(3):207-12. doi: 10.1016/0376-8716(95)01159-8.
Fadardi JS, Cox WM. Reversing the sequence: reducing alcohol consumption by overcoming alcohol attentional bias. Drug Alcohol Depend. 2009 May 1;101(3):137-45. doi: 10.1016/j.drugalcdep.2008.11.015. Epub 2009 Feb 3.
Gullo MJ, Loxton NJ, Dawe S. Impulsivity: four ways five factors are not basic to addiction. Addict Behav. 2014 Nov;39(11):1547-1556. doi: 10.1016/j.addbeh.2014.01.002. Epub 2014 Jan 16.
Peeters M, Wiers RW, Monshouwer K, van de Schoot R, Janssen T, Vollebergh WA. Automatic processes in at-risk adolescents: the role of alcohol-approach tendencies and response inhibition in drinking behavior. Addiction. 2012 Nov;107(11):1939-46. doi: 10.1111/j.1360-0443.2012.03948.x. Epub 2012 Aug 28.
Wiers RW, Rinck M, Dictus M, van den Wildenberg E. Relatively strong automatic appetitive action-tendencies in male carriers of the OPRM1 G-allele. Genes Brain Behav. 2009 Feb;8(1):101-6. doi: 10.1111/j.1601-183X.2008.00454.x. Epub 2008 Nov 11.
Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Dev Cogn Neurosci. 2013 Apr;4:38-51. doi: 10.1016/j.dcn.2012.11.002. Epub 2012 Nov 14.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. doi: 10.1111/jgs.15925.
Wiers RW, Bartholow BD, van den Wildenberg E, Thush C, Engels RC, Sher KJ, Grenard J, Ames SL, Stacy AW. Automatic and controlled processes and the development of addictive behaviors in adolescents: a review and a model. Pharmacol Biochem Behav. 2007 Feb;86(2):263-83. doi: 10.1016/j.pbb.2006.09.021. Epub 2006 Nov 20.
Manning V, Staiger PK, Hall K, Garfield JB, Flaks G, Leung D, Hughes LK, Lum JA, Lubman DI, Verdejo-Garcia A. Cognitive Bias Modification Training During Inpatient Alcohol Detoxification Reduces Early Relapse: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2016 Sep;40(9):2011-9. doi: 10.1111/acer.13163. Epub 2016 Aug 4. Erratum In: Alcohol Clin Exp Res. 2017 Aug;41(8):1526. doi: 10.1111/acer.13439.
Public notes

Contacts
Principal investigator
Name 0 0
Victoria Manning, PhD
Address 0 0
Senior Research Fellow
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02634476