Cognitive mechanisms of an intervention to reduce heavy drinking
| ISRCTN | ISRCTN14874035 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14874035 |
| Secondary identifying numbers | 15/LO/0835 |
- Submission date
- 13/12/2018
- Registration date
- 18/01/2019
- Last edited
- 27/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This in an exploratory research study investigating the styles of thinking and brain changes that are related to alcohol consumption. The study is designed to improve our understanding on alcohol consumption and aspects of psychological functioning, including cognitive process. The study is also interested in whether we can use these processes to change levels of alcohol consumption.
Who can participate?
People aged between 18 and 65 who drink more than 20 units per week if they are female or 30 units per week if they are male, and are interested in reducing their drinking
What does the study involve?
The study involves an appointment at the University of Manchester for a session that lasts up to 4 hours in total. The appointment involves:
1. 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. Positive results would only exclude them from taking part that day and rescheduling would be dependent on the time needed to gain a negative result. This initial appointment can only be rescheduled once following positive results and positive results at the rescheduled appointment would result in full study exclusion.
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
4. Doing some computer tests that provide information about how people react and think in particular ways
5. Completing some questionnaires online
Participants are randomly allocated to either receive a brief paper-based intervention aimed at reducing alcohol intake at the initial appointment, or to be offered the intervention at the end of study. The researchers do not know who received the intervention at the initial appointment until the end of the final appointment. One month later there is another appointment to return and record alcohol consumption, give another breath test and urine sample, and complete some further questionnaires and computer tests which should take up to an hour. All urine samples are immediately destroyed after testing.
What are the possible benefits and risks of participating?
There are no direct benefits of taking part. There are indirect benefits of improving knowledge around alcohol use and potentially informing future research. There are also no direct risks pertaining to the measures used that would not be encountered in everyday life.
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?
May 2015 to December 2017
Who is funding the study?
Investigator PhD initiated and funded
Who is the main contact?
Elly McGrath
Contact information
Scientific
G.708 Stopford Building
University of Manchester
Oxford Road
Manchester
M139PT
United Kingdom
 ORCID ID |
0000-0003-2328-0079 |
|---|
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 | Cognitive mechanisms of an intervention to reduce heavy drinking: a randomised controlled trial |
| Study objectives | H1: Participants randomised to form implementation intentions will show significant reductions in alcohol consumption at one month follow-up compared to those undertaking a control intervention. H2: Participants randomised to form implementation intentions will show significantly improved performance on all neuropsychological tasks compared to those undertaking a control intervention at immediate and one month follow-up. |
| Ethics approval(s) | NHS South East Coast – Brighton and Sussex Research Ethics Committee, 26/05/2015, ref: 15/LO/0835 |
| Health condition(s) or problem(s) studied | Excessive alcohol consumption |
| 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. They then completed a maximum 4 hour session comprising personality measures and neuropsychological testing. All measures were computerised and participants performed the tests in a designated quiet testing room, with comfort breaks as required. The intervention and control conditions received near identical paper sheets during the intervention/control element of the study. These packs were created and numbered prior to randomisation and the researcher was blind as to which numbers relate to which condition. Both intervention and control packs contained some examples of alcohol units and a list of "situations" and "solutions". The intervention group were instructed to link specific situations with specific solutions. The control group were asked to tick all that apply to themselves in both columns. After completion of the implementation intentions helpsheet, all neuropsychological tasks were repeated by all participants as an immediate follow-up. Participants were then given a link at initial appointment and be asked to complete some sub-clinical and personality questionnaires in their own time over the following week. One month after this appointment, participants will completed another 28 day Timeline Followback as well as all questionnaires and neuropsychological tasks once more. |
| Intervention type | Behavioural |
| Primary outcome measure | Alcohol consumption was measured using a 28-day Timeline Followback at baseline and one month follow-up |
| Secondary outcome measures | Cognition was measured using reaction times and errors on the Stop-Signal, Alcohol Stop-Signal, Alcohol Stroop, Approach Avoidance, Delay Discounting and Sternberg tasks. These were measured at baseline, post-intervention and one month follow-up |
| Overall study start date | 22/05/2015 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 116 |
| Total final enrolment | 92 |
| Key inclusion criteria | 1. Aged 18+ 2. The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form 3. The participant is able to read, comprehend and record information written in English 4. A signed and dated written informed consent is obtained from the participant 5. The participant has expressed an interest in reducing current alcohol consumption 6. Consumption of 30 or more units of alcohol per week for men, and 20 or more units per week for women (1.5 times the UK Government guidelines of 2-3 drinks per day for women and 3-4 drinks per day for men with two nights off a week)but not meet 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 halflife of cannabinoid metabolites. This exclusion criteria 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 |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 01/12/2017 |
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 | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | To submit to publish in 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, from regulatory authorities or from the NHS Trust, 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2019 | 27/09/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/09/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
25/01/2019: Internal review.
