Can Cognitive-bias Modification Training During Inpatient Alcohol Detoxification Reduce Relapse Rates Post-discharge?

NCT02634476 | Completed

• 1 other identifier: E33-1314
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence

Keywords

Alcohol; Substance use disorder; cognitive bias; behavioral intervention; computerised training

Outcome Measures

Primary Outcomes (1)

• Alcohol abstinence

  We will assess whether the participant has consumed alcohol at any time between exiting the detoxification facility and completing the 2-week follow-up questionnaires.

  2-week follow-up

Secondary Outcomes (6)

• Days until relapse

  2-week follow-up

• Number of heavy drinking days

  2-week follow-up

• Alcohol craving

  Immediately after the 4th training session (days 6 or 7 following admission)

• Alcohol craving

  2-week follow-up

• Abstinence at 3-months

  3-month follow-up

Study Arms (2)

cognitive bias modification training

EXPERIMENTAL

Participants complete four sessions of the alcohol approach/avoidance task.

Behavioral: Alcohol approach/avoidance task

sham training

SHAM COMPARATOR

Participants complete four sessions of the sham approach/avoidance task.

Behavioral: Sham approach/avoidance task

Interventions

Alcohol approach/avoidance task BEHAVIORAL

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).

Also known as: Alcohol-AAT, Alcohol cognitive bias modification training

cognitive bias modification training

Sham approach/avoidance task BEHAVIORAL

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).

Also known as: Sham-AAT, Sham cognitive bias modification training

sham training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turning Point: lead
• Monash University: collaborator
• Deakin University: collaborator

Study Sites (1)

Wellington House

Box Hill, Victoria, 3128, Australia

Location

Related Publications (13)

• 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.

  PMID: 21389338 BACKGROUND

• 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.

  PMID: 24164417 BACKGROUND

• 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.

  PMID: 22436562 BACKGROUND

• 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.

  PMID: 11050020 BACKGROUND

• 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.

  PMID: 8556969 BACKGROUND

• 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.

  PMID: 19193499 BACKGROUND

• 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.

  PMID: 24576666 BACKGROUND

• 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.

  PMID: 22632107 BACKGROUND

• 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.

  PMID: 19016889 BACKGROUND

• 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.

  PMID: 23218805 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 17116324 BACKGROUND

• 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.

  PMID: 27488392 DERIVED

Related Links

• Sobell, LC.; Sobell, MB. Timeline follow-back: A technique for assessing self-reported alcohol consumption. In: Raye, Z.; Litten, JPA., editors. Measuring alcohol consumption: Psychosocial and biochemical methods. Totowa, NJ: Humana Press, Inc; 1992
• Singleton, E.G., Tiffany, S.T. \& Henningfield, J.E. (2000). Alcohol Craving
• Lovibond, S.H. \& Lovibond, P.F. (1995). Manual for the Depression Anxiety Stress Scales. (2nd. Ed.) Sydney: Psychology Foundation.
• Stockwell, T., Murphy, D., \& Hodgson, R. (1983). The severity of alcohol dependence questionnaire: its use, reliability and validity. British journal of addiction, 78(2), 145-155. doi: 10.1111/j.1360-0443.1983.tb05502.x

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Victoria Manning, PhD

  Senior Research Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: December 18, 2015
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

AU (1)