Alcohol Use Disorder (AUD)ACLIMAGENCT04958655
Mental Imagery Intervention for Alcohol Craving
A study testing Tetris Task and Mental Imagery for Craving Reduction in people with Alcohol Use Disorder (AUD), run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Tetris Task and Mental Imagery for Craving Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2021to 21 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
London
About this study
Official title: Estimating the Acute Impact of Competing Mental Imagery on Craving in Alcohol Use Disorder
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.
Read the 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:
- Tetris then Positive Image
- 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Tetris Task, Mental Imagery for Craving Reduction
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetris TaskBehavioural
a visual task where participants are asked to play 'tetris' i.e. attend to and manipulate shapes and positions on screen
Mental Imagery for Craving ReductionBehavioural
a behavioural mental imagery intervention where participants are asked to generate a specific future mental image to reduce cue-induced craving for alcohol
| Study group | Role | What they receive |
|---|---|---|
| Tetris, Positive Image | Other | Participants randomised to order of intervention: this arm has; Tetris (Active Comparator) then Positive Future Image (Intervention). Receives: Behavioral: Tetris Task; Behavioral: Mental Imagery for Craving Reduction |
| Positive Image, Tetris | Other | Participants randomised to order of intervention: this arm has; Positive Future Image (Intervention) then Tetris (Active Comparator). Receives: Behavioral: Tetris Task; Behavioral: Mental Imagery for Craving Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Craving Experience Questionnaire - Strength Version (CEQ-S) Score
This is a brief, valid and generic measure of craving/desire based on the Elaborated Intrusion Theory of Desire (Kavanagh et al.,2005) and will be completed; 1) on arrival, 2) following the first cue-induction, 3) following the first condition: the tetris task or positive image, 4) following the second cue-induction, 5) following the second condition: the tetris. The CEQ-S measure comprises of 11 items that capture the intensity, imagery and intrusiveness of craving experiences. In the strength scale, participants are asked to rate their experience on a 0-10 likert scale (0=not at all to 10=extremely). Max score = 110 Min score = 0. Higher scores indicate higher strength of craving.
Measured: Throughout study completion, an average of 1.5 hours
Secondary outcomes (4)
Clinical Outcomes in Routine Evaluation-Outcome Measure: CORE-10
This is a valid, reliable and brief 10-item version of CORE-OM used as a screening tool and outcome measure. Items cover anxiety, depression, trauma, physical problems, functioning and risk to self. CORE-10 was designed to assess global distress, such as symptoms of anxiety, depression, risk to self and associated aspects of life and social functioning. Participants rate their level of agreement to the statement on a five-point likert scale (0-4), ('not at all', 'only occasionally', 'sometimes', 'often' and 'most or all of the time') over the last week. Scores range from 0-40. A score on the CORE-10 of 11-15 is indicative of mild psychological distress, 16-20 is moderate, 21-25 equating moderate to severe and 26 and over indicating severe psychological distress.
Measured: Approx. minute 5
Prospective Imagery Task (PIT)
Participants are asked to form a mental image of negative future scenarios and positive future scenarios. The scenarios are comprised of the subjective probability items used by MacLeod et al. (1996) and include events such as ''You will have a serious disagreement with your friend'' or ''You will do well on your course''. Each image is rated for vividness on a continuous 5-point Likert scale anchored at each point from (1) no image at all; (2) vague and dim; (3) unclear but recognisable; (4) moderately vivid; and (5) very vivid. Holmes and colleagues (2008) have adapted a shortened version on this task using 10 negative future scenarios and 10 positive future scenarios, which shall be adopted here. Scores can range from 0-100. Higher scores indicate greater vividness.
Measured: Approx. minute 7
SCID-5-CV (Dependence and remission questionnaire). The structured clinical Interview for Diagnostic and Statistical Manual for Mental Disorders. Clinician Version (DSM-5)
This is a valid and reliable semi-structured interview guide intended to determine whether an individual meets the criteria for the specified DSM V diagnoses and to measure severity of dependence.
Measured: Approx. minute 20
Vividness Rating of Positive Image
This will be measured via 0-100 scale with participant rating how vivid the imaged image was that they generated. Higher score indicates higher vividness.
Measured: Approx. minute 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start20 Sep 2021
- Primary completion21 May 2022
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John Marsden, Prof, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958655
- Sponsor's protocol ID
- 295682
- Acronym
- ACLIMAGE
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Acute Impact of Competing Mental Imagery on Craving in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04958655
- Acronym / sponsor ID
- ACLIMAGE / 295682
- Conditions
- Alcohol Use Disorder (AUD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 21 May 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Tetris then Positive Image
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetris, Positive Image | Other | Behavioral: Tetris Task, Behavioral: Mental Imagery for Craving ReductionParticipants randomised to order of intervention: this arm has; Tetris (Active Comparator) then Positive Future Image (Intervention). |
| Positive Image, Tetris | Other | Behavioral: Tetris Task, Behavioral: Mental Imagery for Craving ReductionParticipants randomised to order of intervention: this arm has; Positive Future Image (Intervention) then Tetris (Active Comparator). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Cognitive impairment
- Undergoing detoxification for alcohol
- Presence of a psychotic disorder.
- Recent parasuicidal behaviour (last month).
- High levels of intoxication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetris Taska visual task where participants are asked to play 'tetris' i.e. attend to and manipulate shapes and positions on screen | Behavioural | Positive Image, Tetris, Tetris, Positive Image |
| Mental Imagery for Craving Reductiona behavioural mental imagery intervention where participants are asked to generate a specific future mental image to reduce cue-induced craving for alcohol | Behavioural | Positive Image, Tetris, Tetris, Positive Image |
Primary outcome
Change from baseline in Craving Experience Questionnaire - Strength Version (CEQ-S) Score
Time frame: Throughout study completion, an average of 1.5 hours
This is a brief, valid and generic measure of craving/desire based on the Elaborated Intrusion Theory of Desire (Kavanagh et al.,2005) and will be completed; 1) on arrival, 2) following the first cue-induction, 3) following the first condition: the tetris task or positive image, 4) following the second cue-induction, 5) following the second condition: the tetris. The CEQ-S measure comprises of 11 items that capture the intensity, imagery and intrusiveness of craving experiences. In the strength scale, participants are asked to rate their experience on a 0-10 likert scale (0=not at all to 10=extremely). Max score = 110 Min score = 0. Higher scores indicate higher strength of craving.
4 secondary outcomes
Clinical Outcomes in Routine Evaluation-Outcome Measure: CORE-10
Time frame: Approx. minute 5
Prospective Imagery Task (PIT)
Time frame: Approx. minute 7
SCID-5-CV (Dependence and remission questionnaire). The structured clinical Interview for Diagnostic and Statistical Manual for Mental Disorders. Clinician Version (DSM-5)
Time frame: Approx. minute 20
Vividness Rating of Positive Image
Time frame: Approx. minute 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Marsden, Prof principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetris Task and Mental Imagery for Craving Reduction in people with Alcohol Use Disorder (AUD), run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Craving Experience Questionnaire - Strength Version (CEQ-S) Score (time frame: Throughout study completion, an average of 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.