NCT04958655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2022

Completed
Last Updated

May 24, 2022

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

June 25, 2021

Last Update Submit

May 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Throughout study completion, an average of 1.5 hours

Secondary Outcomes (4)

  • Clinical Outcomes in Routine Evaluation-Outcome Measure: CORE-10

    Approx. minute 5

  • Prospective Imagery Task (PIT)

    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)

    Approx. minute 20

  • Vividness Rating of Positive Image

    Approx. minute 60

Study Arms (2)

Tetris, Positive Image

OTHER

Participants randomised to order of intervention: this arm has; Tetris (Active Comparator) then Positive Future Image (Intervention).

Behavioral: Tetris TaskBehavioral: 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).

Behavioral: Tetris TaskBehavioral: Mental Imagery for Craving Reduction

Interventions

Tetris TaskBEHAVIORAL

a visual task where participants are asked to play 'tetris' i.e. attend to and manipulate shapes and positions on screen

Positive Image, TetrisTetris, Positive Image

a behavioural mental imagery intervention where participants are asked to generate a specific future mental image to reduce cue-induced craving for alcohol

Positive Image, TetrisTetris, Positive Image

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • years and older.
  • Proficient use of the English language to complete questionnaires and an interview.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John Marsden, Prof

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 12, 2021

Study Start

September 20, 2021

Primary Completion

May 21, 2022

Study Completion

May 21, 2022

Last Updated

May 24, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations