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

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ClinicalTrials.gov Identifier: NCT02634476
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : October 25, 2016
Sponsor:
Collaborators:
Monash University
Deakin University
Information provided by (Responsible Party):
Turning Point

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: Alcohol approach/avoidance task Behavioral: Sham approach/avoidance task Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Can Cognitive-bias Modification Training During Inpatient Alcohol Detoxification Reduce Relapse Rates Post-discharge?
Study Start Date : June 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: cognitive bias modification training
Participants complete four sessions of the alcohol 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).
Other Names:
  • Alcohol-AAT
  • Alcohol cognitive bias modification training

Sham Comparator: sham training
Participants complete four sessions of the sham approach/avoidance task.
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).
Other Names:
  • Sham-AAT
  • Sham cognitive bias modification training




Primary Outcome Measures :
  1. Alcohol abstinence [ Time Frame: 2-week follow-up ]
    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.


Secondary Outcome Measures :
  1. Days until relapse [ Time Frame: 2-week follow-up ]
    In those who drink before the 2-week follow-up, we will assess the number of days between discharge from detoxification and their first drink of alcohol.

  2. Number of heavy drinking days [ Time Frame: 2-week follow-up ]
    We will assess the number of days, in the 14 days prior to the 2-week follow-up, on which the participant consumed at least 5 standard drinks of alcohol.

  3. Alcohol craving [ Time Frame: Immediately after the 4th training session (days 6 or 7 following admission) ]
    We will assess craving for alcohol following the final session with both a visual analogue scale and the Alcohol Craving Questionnaire (Short Form - Revised).

  4. Alcohol craving [ Time Frame: 2-week follow-up ]
    We will assess craving for alcohol following the final session with the Alcohol Craving Questionnaire (Short Form - Revised).

  5. Abstinence at 3-months [ Time Frame: 3-month follow-up ]
    We will assess whether the participant has consumed alcohol at any time during the 30 days prior to the 3-month follow-up.

  6. Decision-making [ Time Frame: Immediately after the 4th training session (days 6 or 7 following admission) ]
    The Iowa Gambling Task will be administered following the final training session.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634476


Locations
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Australia, Victoria
Wellington House
Box Hill, Victoria, Australia, 3128
Sponsors and Collaborators
Turning Point
Monash University
Deakin University
Investigators
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Principal Investigator: Victoria Manning, PhD Senior Research Fellow
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Turning Point
ClinicalTrials.gov Identifier: NCT02634476    
Other Study ID Numbers: E33-1314
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Turning Point:
Alcohol
Substance use disorder
cognitive bias
behavioral intervention
computerised training
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs