Clinical trial NCT04958655: Mental Imagery Intervention for Alcohol Craving
Official title: Estimating the Acute Impact of Competing Mental Imagery on Craving in Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2021-07-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent.
* Engaging in working with a community substance misuse service
* Meets DSM-V criteria for alcohol dependency or abuse, or in early recovery.
* Alcohol is the primary substance of dependence.
* 18 years and older.
* Proficient use of the English language to complete questionnaires and an interview.

Exclusion Criteria:

* Cognitive impairment
* Undergoing detoxification for alcohol
* Presence of a psychotic disorder.
* Recent parasuicidal behaviour (last month).
* High levels of intoxication.
* Severe neurodevelopmental disorder (for example Autism/ADHD) that is deemed to impact on the participants' ability to undertake the interview.
* Organic brain injury, including Korsakoff syndrome.
* Currently participating, or recently participated (last month), in other research.

Primary outcomes:
measure: Change from baseline in Craving Experience Questionnaire - Strength Version (CEQ-S) Score
timeFrame: Throughout study completion, an average of 1.5 hours
Secondary outcomes:
measure: Clinical Outcomes in Routine Evaluation-Outcome Measure: CORE-10
timeFrame: Approx. minute 5
measure: Prospective Imagery Task (PIT)
timeFrame: Approx. minute 7
measure: SCID-5-CV (Dependence and remission questionnaire). The structured clinical Interview for Diagnostic and Statistical Manual for Mental Disorders. Clinician Version (DSM-5)
timeFrame: Approx. minute 20
measure: Vividness Rating of Positive Image
timeFrame: Approx. minute 60
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
Study officials:
affiliation: King's College London
name: John Marsden, Prof
role: PRINCIPAL_INVESTIGATOR
References: