Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04958655 |
| Other study ID # |
295682 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2021 |
| Est. completion date |
May 21, 2022 |
Study information
| Verified date |
June 2021 |
| Source |
King's College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A within-subjects crossover, randomised controlled trial conducted at a specialist NHS
outpatient addictions clinics to determine if mental imagery (of future positive [recovery
oriented] events) and a visuospatial task (playing Tetris) can help reduce cue-induced
alcohol craving. Effects of both interventions will be compared.
Description:
Alcohol misuse has a devastating economic impact, with alcohol misuse reportedly costing the
UK £20 billion a year. The burden on the health system is also well recognized, with for
example, 70% of all admissions to A&E could be linked to alcohol misuse. Meanwhile, the links
between alcohol misuse and mental health conditions is well recognized, where the prevalence
of patients who have a dual diagnosis of Alcohol Use Disorder (AUD) and another psychiatric
condition, is well-established in the literature.
Some cognitive models of substance misuse have also hypothesized about the central role that
imagery can have in the initiation and maintenance of addiction. The Elaborated Intrusion
(EI) Theory hypothesises that elaborating on alcohol related imagery is integral to the
craving experience which ultimately leads to drinking. The EI theory describes craving
beginning with an intrusive thought, triggered automatically by external or physiological
cues, and associated cognitions. Where these thoughts are pleasurable, the individual will
likely elaborate. Elaboration is an effortful cognitive event, where sensory information
about the substance is searched for and held in working memory as an image. The theory
suggests that during the elaboration process, increasingly rich cues serve to heighten the
vividness of consumption imagery, giving acquisition even greater urgency and attentional
priority. These images are initially rewarding but as elaboration continues, awareness of
somatic deficit and negative affect will occur where the target is not acquired and consumed.
As the elaboration is effortful, the theory proposes that the construction and maintenance of
these desire images takes up limited working memory capacity. Therefore, the EI theory
suggests that were elaboration is disrupted, through a competing task, craving will reduce.
Tetris has now been tested across craving populations to test the EI theory. Research groups
have found that playing Tetris was significantly better than a control condition (watching a
loading screen) at reduced self-reported craving for a range of targets. Tetris, therefore
appears to be an easily accessible tool to operationalise as a means to interfere with
visuo-spatial elaboration during craving for patients.
The researchers who developed the EI theory, hypothesise that familiar, habitual sensory
imagery around a desired substance will hold vividness and emotive power that is easily
maintained where competing imagery is weak and less meaningful or vivid to the individual. In
the researcher's view, this is what explains relapse to alcohol, as competing tasks do not
hold sufficient pleasure or reward during craving to engage individuals attention. Therefore,
while they may agree with evidence that 'blocking' the elaboration of imagery processes is a
useful (and more effective start than other non-imagery based distraction tasks), they
hypothesise that a personalised and meaningful image with significant reward feature should
outperform a visuo-spatial task, such as Tetris, in blocking the craving processes.
Findings support this, suggesting that personally meaningful aspirational or 'positive'
images around abstaining can be effective in reducing urges to use. For example, in piloting
'Functional Imagery Training' (FIT), researchers found that patients who rehearsed
multisensory positive goal imagery lost more weight and reduced snacking more than a wait
list control group. However, no study has compared this 'positive/motivational image'
approach to an alternative visuo-spatial working memory task.
This study has the following aims:
- To determine if visualising a meaningful/positive image reduces craving more than
engaging in a non-meaningful visuo-spatial task in alcohol use disorder.
- To determine if the vividness of the positive image generated impacts the efficacy of
the imagery intervention.
- To determine the pre-morbid ability of the sample in generating prospective/future
imagery.
- To determine if the pre-morbid ability for generating prospective/future images impact
the efficacy of the imagery intervention.
Participants will be recruited from specialist NHS outpatient addictions clinics (Wandsworth,
Bexley and Lambeth community substance misuse services).
Informed consenting adult participants will be randomised to one of two conditions during a
single session research appointment:
1. Tetris then Positive Image
2. Positive Image then Tetris
Participants will undergo a craving induction procedure designed to elicit cue-induced
craving. In response to elevated craving, participants will be asked to reduce craving levels
using a positive future mental imagery intervention and playing Tetris.
Participants will be fully debriefed and provided time to ask any questions they may have. A
craving reduction task will also be offered. Participants will also be asked to identify a
named person they can contact if they later feel concerned or distressed. Where required,
signposting to support will be offered.
