Investigating cognitive training tasks to reduce heavy drinking
| ISRCTN | ISRCTN35503634 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35503634 |
| Secondary identifying numbers | 2017-0513-543 |
- Submission date
- 13/12/2018
- Registration date
- 18/01/2019
- Last edited
- 11/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The study is designed to improve our understanding of aspects of cognitive functioning associated with alcohol consumption. The researchers plan to investigate how the brain responds to certain computerised cognitive tasks involving processing alcohol images. This research will help us understand processes that may be important in developing new ways to help people reduce their current alcohol consumption.
Who can participate?
People aged between 18 and 65 who drink more than 21 units per week and are interested in reducing their drinking
What does the study involve?
Participants complete a screening questionnaire to check whether they can take part in the main study. This include questions about their medical history and can be done online. The main appointment for this study involves:
1. Attending the University of Manchester and giving a breath test and urine sample to ensure no presence of drugs or alcohol that day. A minimum list of drugs that are screened for includes amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. A positive result for one of these drugs would only exclude participants from taking part that day. After a single positive result, their appointment will be reschedule after allowing time for whichever drug screened positive to clear their system (this time will dependent on the substance in question). A second positive result at the rescheduled appointment would result in full study exclusion. All urine samples will be immediately destroyed after testing
2. Being asked about drug and alcohol use, as well as briefly about mental and physical health
3. Filling in some questionnaires to assess personality, alcohol use (in detail) and current mood
4. Doing some practice versions of the computer tasks that will be conducted within the MRI scanner. These provide information about how people react and think in particular ways
5. Walking with the researcher over to the Clinical Research Facility on Grafton Street to complete the full versions of these computer tasks within an MRI scanner that takes about one hour. Participants do each task twice, before and after some task-specific instructions
6. Undergoing a short structural scan within the MRI scanner
Four weeks after the main appointment, participants are contacted by the researcher by telephone or email to ask about alcohol consumption since the scan.
What are the possible benefits and risks of participating?
There were no direct benefits of taking part. There are indirect benefits of improving knowledge around alcohol use and potentially informing future research. The principal investigator will complete a detailed safety debriefing concerning the use of the MR scanner and standard safety procedures to be used by the clinical team will be adhered to. The only risks associated with MRI are for people with certain established contraindications, including heart pacemakers and metal surgical clips or implants in the head or neck. The CRF scanner has established safety procedures, including a detailed checklist that the radiographers go through with all participants prior to scanning. MRI scanning is generally well tolerated but some participants find the scanner environment claustrophobic and/or too noisy. Participants are provided with ear protection and a panic button which they can press to stop the scan at any time.
Where is the study run from?
The University of Manchester (UK)
When is the study starting and how long is it expected to run for?
July 2017 to December 2017
Who is funding the study?
Investigator PhD funded
Who is the main contact?
Elly McGrath
Contact information
Scientific
Room 405, Mathematical Sciences Building
Peach Street
Liverpool
L69 7ZL
United Kingdom
 ORCID ID |
0000-0003-2328-0079 |
|---|---|
| Phone | +44 (0)151 794 4002 |
| eking@liv.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Investigating cognitive training tasks to reduce heavy drinking: a randomised controlled trial |
| Study objectives | This study hypothesises that participants receiving implementation intentions will show reduced alcohol consumption, greater improvement on behavioural training task performance and increased activity in the medial frontal cortex and inferior frontal gyrus than control participants. |
| Ethics approval(s) | Manchester University REC, 27/03/2017, ref: 2017-0513-543 |
| Health condition(s) or problem(s) studied | Heavy alcohol use |
| Intervention | Participants were randomised using the simple randomisation technique of a random number table. Participants attended the University of Manchester, and following consent, an alcohol breath test and drug urine screen will be obtained. Demographic information was collected and an assessment of drug and alcohol history, including the SCID (Structured Clinical Interview for Depression) for dependence history, was conducted. A 28-day Timeline followback was be used to assess alcohol consumption. The 32 participants attended for a maximum 2 hour session comprising personality measures and neuropsychological testing both inside and outside of the scanner. Participants are randomised to read either an implementation intention or goal intention directed at task performance inside the scanner after the first round of neuropsychological tasks, but before repeating them. All questionnaires and tests were computerised and participants will perform the practice tests and questionnaires in a designated quiet testing room, with comfort breaks as required. The scanning element of the test session took approximately one hour. Questionnaire measures included measures of current alcohol behaviour, attitudes and habits as well as of impulsive behaviours. Participants were contacted one month later to complete another 28 day Timeline Followback via telephone. |
| Intervention type | Behavioural |
| Primary outcome measure | Alcohol consumption measured using a 28-day Timeline Followback at baseline and one month follow-up |
| Secondary outcome measures | 1. Cognition measured using reaction times and errors on the Approach Avoidance and Visual Probe tasks at a single session 2. Blood-oxygen-level dependent (BOLD) activity assessed using MR techniques at a single session |
| Overall study start date | 01/07/2017 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 32 |
| Total final enrolment | 32 |
| Key inclusion criteria | Consumption of 21 or more units of alcohol per week but not meeting SCID criteria for dependence |
| Key exclusion criteria | 1. Participants must not meet criteria for alcohol dependence as per the Structured Clinical Interview for Depression (SCID) (as assessed at online screening and during baseline interview) 2. Positive drug/alcohol screens on testing visits. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. Positive results for cannabinoids will be allowed given the long half-life of cannabinoid metabolites. This exclusion criterion would exclude a subject from completing the study on that day only and not the study as a whole, at the discretion of the research team 3. High dosage use of regular psychoactive prescription medications such as those with antidepressant or anxiolytic properties. 4. History or presence of a neurological diagnosis (not limited to but including, for example, stroke, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack) that may influence the outcome of any cognitive testing 5. Clinically significant head injury (e.g., requiring medical or surgical intervention) 6. Unwillingness or inability to follow the procedures outlined in the protocol 7. Significant current or past psychiatric history, including Major Depression, Generalised Anxiety Disorders, or anything that involves referral to secondary services and/or significant functional impairment 8. Neuroendocrine disorder, including impaired thyroid function and steroid use 9. Female participants who are, or may be, pregnant 10. Those with any contraindications for MRI scanning will be excluded |
| Date of first enrolment | 14/07/2017 |
| Date of final enrolment | 14/11/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9PT
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M139PT
England
United Kingdom
| Website | www.manchester.ac.uk |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Intend to publish in a peer-reviewed journal in 2019. |
| IPD sharing plan | Confidentiality: Each participant will be identified by an individual anonymised code number that will be used throughout the duration of the study. Participant names, addresses, and other contact details will be stored securely (in a locked filing cabinet) and kept completely separate from all their data. Only fully anonymised data will be stored on laptop computers which cannot be traced to individuals without study codes filed separately and only accessible to the research team. Computerised databases containing anonymised data will additionally be fully encrypted using the high level encryption software recommended by the University of Manchester. Urine samples will be identified by code number only and will be destroyed immediately after screening. Unanonymised personal data will only be accessible to the study team. Additionally, study data and material may be looked at by individuals from the University of Manchester for essential monitoring and auditing purposes, and this may well include access to personal information. Consent forms will be retained as essential documents, but items such as contact details will be deleted as soon as they are no longer needed. The University of Manchester policy on storage of data is 5 years after the last publication of the study or for 10 years, whichever is the greater. Alcohol consumption change and cognitive tasks will be analysed using univariate and multivariate techniques from SPSS as appropriate. Imaging data will be analysed using multivariate techniques from SPM for MATLAB as appropriate. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/05/2020 | 11/12/2019 | Yes | No |
Editorial Notes
11/12/2019: Publication reference and total final enrolment number added.
01/10/2019: The following changes have been made:
1. The scientific contact's details have been updated.
2. The intention to publish date has been changed from 01/04/2019 to 31/12/2019.
25/01/2019: Internal review.
