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A randomised controlled trial of Cognitive Bias Modification training during early recovery from alcohol dependence.

A randomised controlled trial to determine the effectiveness of Cognitive Bias Modification training during inpatient alcohol withdrawal on alcohol consumption rates 2 weeks, 3 months, 6-months, and 1 year post-discharge.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001241325
Enrollment
300
Registered
2017-08-25
Start date
2017-06-04
Completion date
2019-07-14
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This multi-site parallel groups randomised controlled trial will aim to recruit 300 alcohol-dependent patients (aged 18-65) admitted for inpatient detoxification at De Paul House (St. Vincent’s Hospital Melbourne), Wellington House (Eastern Health) or Windana Drug and Alcohol Recovery. The primary aim is to determine the effectiveness of CBM training during inpatient alcohol detoxification in terms of increased abstinence rates 2 weeks following discharge,relative to controls who receive sham training. We also aim to explore rates of abstinence, 3, 6, and 12 months post-discharge as a secondary outcome. Another secondary aim is to determine if pre-training levels of approach or attentional bias moderate the effectiveness of CBM, based on the hypothesis that those who drink due to strong cognitive biases are likely to benefit from treatments targeting these biases, while those with low cognitive biases, whose drinking is driven by other factors (e.g. relief from distress) may benefit less from CBM. We also aim to measure the difference between groups in rates of use of further inpatient withdrawal and acute health services during the year following discharge to assess whether CBM training leads to cost savings to the health system, and to measure differences between groups in cue-induced desire for alcohol following CBM training. We hypothesise that, compared to those receiving sham training, participants receiving CBM training will show significantly higher rates of abstinence from alcohol at all followups. We also anticipate that stronger baseline attention and approach bias will be associated with a larger effect of CBM (i.e., baseline attention/approach biases will moderate CBM’s effect on abstinence). We expect significant net cost saving in the CBM group compared to controls in terms of reduced cost of repeated inpatient detoxification treatment and acute health care use during the year following discharge (after accounting for the costs of implementing CBM training in the CBM group). Compared to those receiving sham training, participants receiving CBM training will show significantly reduced cue-induced desire to alcohol images (but not to images of non-alcoholic beverages). We expect that this interaction will remain, with similar effect size, when analyses are restricted to images not included in the training task, demonstrating generalisation of reduced cue-induced desire beyond the specific stimuli that participants were trained to avoid.

Interventions

CBM Intervention: Many substance abusers have impaired ability to regulate and monitor their behaviour. According to the "dual process" model, addiction arises from an imbalance between overactive “bottom-up” automatic (impulsive) processes that drive behaviours and impaired "top-down" controlling processes that stop behaviours associated with negative consequences. As a result, the individual’s addictive behaviour becomes more easily triggered by alcohol related cues in their environment, but l

CBM Intervention: Many substance abusers have impaired ability to regulate and monitor their behaviour. According to the "dual process" model, addiction arises from an imbalance between overactive “bottom-up” automatic (impulsive) processes that drive behaviours and impaired "top-down" controlling processes that stop behaviours associated with negative consequences. As a result, the individual’s addictive behaviour becomes more easily triggered by alcohol related cues in their environment, but less able to be inhibited once triggered. The exaggerated tendency to attend and react to alcohol related cues is called “cognitive bias”. Cognitive bias modification (CBM) is a computer based training paradigm that trains the brain to inhibit the tendency to approach negative/harmful cues. This approach both minimizes the overactive "bottom-up" processes and improves the "top-down" control processes. In the intervention CBM task, participants will be exposed to 240 computerised images of 40 different alcoholic and 40 different non-alcoholic drinks and instructed to respond with an approach or avoidance movement according to their orientation (landscape or portrait). While instructions are based on picture orientation, one orientation will contain images of alcoholic beverages 95% of the time (and non-alcoholic beverages 5% of the time) and will require an avoidance movement (pushing of a joystick, which decreases image size). The other orientation will contain non-alcoholic beverages 95% of the time and alcoholic beverages 5% of the time and will require an approach movement (pulling the joystick, which increases image size). The requirement to push away nearly all (95%) of alcohol images is intended to train participants to over-ride their pre-existing tendency to approach alcohol, and we hope that this will generalise to a reduced tendency to approach alcohol and its related cues following discharge from detoxification. This requirement will be reversed on 5% of trials to reduce the likelihood of participants being un-blinded to the nature of the training. The training task usually takes approximately 15 minutes. It will be repeated on each of the three following days, such that the participant receives four consecutive days of training while in detoxification. The intervention will be administered by trained and qualified researchers employed by Turning Point (Eastern Health) or Monash University. Training will commence no earlier than the 3rd day of inpatient withdrawal, though may be commenced later as long as there are 4 consecutive days available on which to conduct the training prior to the participant’s planned discharge day. In cases where participants receive the “standard” 7-day inpatient withdrawal, we aim to time sessions such that the final session will occur the day before discharge. However, due to variations in length of admission that sometimes occur, with some admissions lasting up to 2 weeks, the timing of training relative to the date of discharge will vary. Data collectors will report any deviations from intervention adherence to the project manager, who will maintain a record of these deviations. Deviations may include interruptions to training sessions (e.g. due to computer errors or other unexpected events), non-standard scheduling of sessions (e.g. skipping a day, due to a participant being unwell or unavailable on a day a session is planned), or failure to complete 4 sessions due to unexpected early discharge from the withdrawal unit. All participants who commence training will be included in analyses, according to intention-to-treat principles, but participants who do not complete 4 sessions will be excluded from secondary per-protocol analyses.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Participants will be 300 alcohol-dependent patients (aged 18-65) admitted for inpatient detoxification at De Paul House (St. Vincent’s Hospital Melbourne), Wellington House (Eastern Health) or Windana Drug and Alcohol Reovery. Inclusion criteria are: 1. Current moderate or severe DSM-5 alcohol use disorder (i.e. at least 4 alcohol use disorder criteria met within the past year, according to the Structured Clinical Interview for DSM-5 Disorders – Research Version (SCID-5-RV; First, Williams, Karg, & Spitzer, 2015). 2. Report at least weekly use of alcohol in the past month. 3. Be able to understand English.

Exclusion criteria

Exclusion criteria are: 1. History of neurological illness or injury or brain trauma involving loss of consciousness for longer than 30 minutes. 2. Intellectual disability. 3. Acutely unwell, as judged by clinical staff.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026