Can Cognitive-bias Modification Training During Inpatient Alcohol Detoxification Reduce Relapse Rates Post-discharge?
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

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.
    

Detailed description: 
      Detailed Description:

      According to the dual-process model of addiction (Gullo, Loxton, & Dawe, 2014), addictive
      behaviour is the result of an imbalance between a strong, impulsive processing system and a
      relatively weak, reflective processing system. Due to this imbalance, impulsive preferences
      are rewarded, reflected in an increased sensitivity to the stimuli of addiction (i.e.,
      attentional bias) and an automatic tendency to engage with the stimuli of addiction (i.e.,
      approach bias; Wiers et al., 2007). Clinical trials of CBM have begun to emerge for
      individuals with alcohol use disorders (Fadardi & Cox, 2009). Wiers et al. (2009) developed
      the alcohol approach/avoidance task (alcohol-AAT), where participants respond with an
      approach behaviour (pulling a joystick) or an avoidance behaviour (pushing a joystick) to
      pictures of addiction-related and neutral stimuli. Following four sessions of this training
      task patients displayed better treatment outcomes one-year later (Wiers et al., 2011). A
      study by Eberl et al. (2013) found that 12 sessions of approach-bias modification training
      was associated with higher rates of abstinence at one-year relative to controls.

      Underlying the relationship between cognitive biases and addiction, within the dual-process
      model paradigm, are impulse-control processes. However, the relationship between impulsivity
      and cognitive biases remains unclear. Indeed, individuals with weak inhibition skills tend to
      have a bias toward automatic information processing (Gladwin et al., 2011) and impulsivity is
      thought to play a role in the degree to which cognitive biases influence outcomes (Peeters et
      al., 2012). The development of this understanding will benefit assessment of CBM treatments
      for addiction patients.

      Rationale:

      Despite intensive psychosocial interventions, most alcohol-dependent patients relapse within
      weeks if not days of leaving inpatient detoxification. The study therefore examines whether
      an alcohol approach-bias modification training programme during detox can reduce craving and
      relapse in alcohol-dependent inpatients. By dampening the automatic tendency to approach
      alcohol-related stimuli, individuals are allowing time to make more informed behaviour
      choices (i.e., improving their decision-making ability). Its impact will be examined through
      abstinence rates at 2-weeks and 3-months relative to those receiving sham training. The
      findings are likely to have implications for the design and delivery of psychosocial
      interventions delivered during early recovery from alcohol-dependence, aiming to optimise
      treatment effectiveness.

      Aims:

        1. To determine if 4-sessions of CBM, using an alcohol approach-bias modification training
           program, delivered during inpatient withdrawal, reduces craving and relapse rates and
           other drinking-related outcomes at 2-weeks and 3-months post-discharge.

        2. To determine if CBM, using alcohol approach-bias modification training, improves
           decision-making after four training sessions.

        3. To determine if CBM effects (i.e., using alcohol approach-bias modification training)
           are moderated by impulsivity.

      Hypotheses:

        1. CBM (using alcohol approach-bias modification training) will lead to significantly
           higher rates of abstinence at 2-weeks and 3-months and larger reductions in days to
           relapse, percentage of heavy drinking days and craving score, relative to sham training.

        2. CBM (using alcohol approach-bias modification training) will be associated with
           significantly greater improvement in decision-making (Iowa Gambling Task performance)
           after the fourth training session compared to sham training.

        3. Patients with greater impulsivity will show significantly greater responses to CBM
           (using alcohol approach-bias modification training).

      Methodology:

      The study will be a parallel-groups randomized superiority trial comparing CBM (using alcohol
      approach-bias modification training) versus sham training (i.e., control condition) in
      alcohol-dependent participants following residential detoxification treatment. The primary
      outcome variables will be self-reported alcohol use (relapse versus abstinence) 2-weeks and
      3-months post discharge and secondary outcomes will include: days to relapse, percentage of
      heavy drinking days, alcohol craving and Iowa Gambling Task performance (i.e.,
      decision-making) immediately post-intervention.

      Assignment:

      Randomisation will be carried out according to the ICH Guideline by an independent
      statistician not involved in the day-to-day conduct of the trial. Following baseline
      assessments, participants will be assigned randomly to the treatment condition using a 1:1
      ratio and randomly permuted blocks.

      Participants:

      The target sample is defined as alcohol-dependent patients seeking treatment at the
      detoxification inpatient unit in Wellington House, Box Hill, Victoria.

      Setting:

      Wellington House, an inpatient detoxification service; part of Turning Point, a state-wide
      Alcohol and other Drug (AOD) service that incorporates Eastern region based services.

      Measures:

      Standard demographic questionnaire including: age, gender, history of alcohol use, previous
      alcohol treatment, employment, income source, housing arrangements, family situation, mental
      health. Current medication regimen, including psychotropic medications. All benzodiazepines
      will be converted to standard dose of diazepam.

      Baseline drug use and clinical measures:

      Alcohol/Drug use: Timeline Followback Interview (TLFB; Sobell & Sobell, 1992): as a measure
      of frequency of alcohol/drug use in the past 4 weeks.

      Baseline alcohol dependence: Severity of Alcohol Dependence Questionnaire (SADQ; Stockwell et
      al, 1983).

      General cognitive functioning: Montreal Cognitive Assessment (MoCA): a brief cognitive
      screening tool of general cognitive functioning (Nasreddine et al, 2005).

      Appetitive motivational behaviour/ impulsivity: The Sensitivity to Reward (SR) part of the
      Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ; Torrubia et. al.,
      2001); specifically measures appetitive motivational behaviour or impulsivity.

      Impulsiveness, venturesomeness, empathy: The I7 Impulsiveness questionnaire (Eysenck,
      Pearson, Easting & Allsopp, 1985) is a 54-item measure consisting of three scales:
      impulsiveness, venturesomeness, and empathy.

      Craving: Assessed using 100mm visual analogue scales (VAS). The VAS provides an index of urge
      to drink using two dimensions (positive and negative urge; Dawe & Gray, 1995).

      Craving: The Alcohol Craving-Short-Form-Revised (ACQ-SF-R: Singleton, 2000) is a 12-item
      measure of craving for alcohol among alcohol users in the current context (right now).

      Depression and anxiety: Seven depression and seven anxiety items of the shortened Depression
      Anxiety and Stress Scale (DASS; Lovibond & Lovibond, 1995).

      Decision-making: A computerised version of the Iowa Gambling Task (IGT; Bechara et al.,
      2000): measures decision-making under conditions of uncertainty and risk of punishment.

      Procedures:

      Recruitment and consent: Participants will be approached by a researcher no earlier than day
      three of admission. All Participants will be provided with a Plain Language statement
      explaining the purpose of the study and what will be required of participants. The study will
      also be explained verbally by the researchers. If the participant chooses to become part of
      the study a written consent form (i.e., Patient Information and Consent Form) will be
      completed. The researcher will also seek consent to contact others and document relevant
      telephone/contact details so that self-reported outcome can be assessed 2-weeks and 3-months
      post-discharge.

      Baseline, intervention and post-intervention outcome assessment: Following the consent
      taking, the baseline assessment will be completed as described in the measures section.
      Participants will then be randomised to one of two conditions, cognitive bias training or
      sham training. On the morning of days 3/4 to days 6/7 (i.e., four consecutive days) of
      admission, participants will undergo the ABM (intervention). Each training session is
      expected to last approximately 15 minutes. Participants will be given the opportunity to take
      an optional break during the intervention. After the final (i.e., fourth) training session,
      participants will complete the post training assessment (decision-making task and craving
      measures).

      Two-weeks and 3 months post discharge the researcher will telephone the participant to use
      the timeline follow-back instrument to document alcohol consumption since discharge and ask
      questions about engagement in treatment since discharge.

      Statistical Analyses:

      The primary hypothesis uses a binary outcome variable (abstinent versus relapse at 2-weeks)
      following completion of the protocol (four sessions) and will be examined using chi-square
      analyses. Secondary outcomes which are continuous variables (i.e., days to relapse,
      percentage of heavy drinking days, mean number of standard drinks, craving scores, IGT score
      etc.) will be examined using mixed effects repeated measures models (MMRM) including type of
      intervention (cognitive bias modification training versus sham training) as the independent
      variable and craving, decision-making, days to relapse and other alcohol consumption outcomes
      as dependent variables. The third hypothesis will be tested with a multiple regression model
      including sensitivity to reward and impulsivity scores at baseline, as predictors of outcome
      (abstinence, days to relapse etc..). Power calculations based on a hypothesized medium effect
      size indicate that a sample size of 72 participants (36 in each group) is required to test
      the study hypotheses with 80% power.
    

Intervention name(s): Alcohol approach/avoidance task; Sham approach/avoidance task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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).; 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 intervention name(s): Alcohol-AAT; Alcohol cognitive bias modification training; Sham-AAT; Sham cognitive bias modification training
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alcohol; Substance use disorder; cognitive bias; behavioral intervention; computerised training