Alcohol AbuseNCT06419647
Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers
A study testing Intervention in people with Alcohol Abuse and Alcohol Drinking, run by Ilona Myllyniemi.
Trial summary
The study aims to investigate the effects that mood tracking may have on the alcohol consumption of adults who consume more than 20 UK units of alcohol per week, classifying as high-risk drinkers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Alcohol Drinking, Alcohol Use Disorder
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Speaking fluent English
- being over 18 years of age
- High completion rates of previous studies on the Prolific platform
- Being located in the United Kingdom
- Consuming over 20 UK units of alcohol per week
Who cannot join
- Having an ongoing mental health condition
Trial locations and contacts
No sites are listed yet.
Ilona S Myllyniemi, PhD Student contact
About this study
The study aims to investigate the effects that mood tracking may have on the alcohol consumption of adults who consume more than 20 UK units of alcohol per week, classifying as high-risk drinkers. The intervention group will track their mood on a daily basis with a visual analogue scale, while the control group will report their daily time spent online. The hypothesis, based on a series of prior pilot studies on alcohol tracking methods, is that mood tracking can reduce alcohol consumption in high-risk drinkers and therefore be a suitable addition to interventions related to decreasing alcohol consumption in heavy drinkers. The study will be conducted online through the Prolific platform.
Read the detailed description
Participants will be recruited through Prolific. All participants will complete a series of demographic and psychometric questionnaires before beginning the study. Participants will also complete some of the psychometric questionnaires (RCQ, GAD-7, PHQ-9) at the end of the study to track any potential changes. Participants will be pre-screened for their motivation using a modified MTSS (Motivation to Stop Smoking) scale. Participants will also be asked to report their primary source of motivation regarding wanting to quit or reduce drinking, in addition to reporting their main goal regarding alcohol, where the options will be wanting to quit, wanting to reduce drinking, wanting to be more in control of their drinking, and not wanting to quit, reduce, or be more in control of drinking. All participants will also report their alcohol consumption using a timeline followback task with the ability to view both a calendar and a reference image of UK alcohol units. They'll report their alcohol consumption from the week before the study and complete two TLFBs during the study.
Intervention group participants complete daily visual analogue scales of their mood. Control group participants complete daily reports of how many hours they spent online the previous day.
- Conditions
- Alcohol Abuse, Alcohol Drinking, Alcohol Use Disorder, Alcohol Dependence, Alcohol Intoxication
- Being tested
- Intervention
- Keywords
- Alcohol, AUD, Mood tracking, EMA, Emotional monitoring, Alcohol tracking
- Medical subject headings
- Alcoholism, Alcohol Drinking, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Alcohol tracking, Mood tracking, Emotional monitoring, EMA
Daily mood tracking tasks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants complete daily mood tracking and weekly timeline followbacks of alcohol use Receives: Behavioral: Intervention |
| Control | No intervention | Participants complete daily logs of time spent online and weekly timeline followbacks of alcohol use |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLFB
Timeline followbacks completed of consumed alcohol units reflecting alcohol units (UK) of alcohol consumed before the study and throughout the study
Measured: 3 weeks
Secondary outcomes (3)
GAD-7
Comparison of potential changes in GAD-7 score before and after study
Measured: 3 weeks
PHQ-9
Comparison of potential changes in PHQ-9 score before and after study
Measured: 3 weeks
RCQ
Comparison of potential changes in Readiness to Change score and Stage of Change destination before and after study
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilona Myllyniemi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Sponsor-investigator, Ilona Myllyniemi, University of Cambridge
- Investigators
- Valerie Voon, PhD, MD, Study director, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419647
- Sponsor's protocol ID
- MOODSTUDYALCOHOL
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, statistical analysis plan, informed consent form will be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers
- ClinicalTrials.gov ID
- NCT06419647
- Acronym / sponsor ID
- MOODSTUDYALCOHOL
- Conditions
- Alcohol Abuse, Alcohol Drinking, Alcohol Use Disorder, Alcohol Dependence, Alcohol Intoxication
- Keywords
- Alcohol, AUD, Mood tracking, EMA, Emotional monitoring, Alcohol tracking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ilona MyllyniemiUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 May 2024 (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.
The study aims to investigate the effects that mood tracking may have on the alcohol consumption of adults who consume more than 20 UK units of alcohol per week, classifying as high-risk drinkers. The intervention group will track their mood on a daily basis with a visual analogue scale, while the control group will report their daily time spent online. The hypothesis, based on a series of prior pilot studies on alcohol tracking methods, is that mood tracking can reduce alcohol consumption in high-risk drinkers and therefore be a suitable addition to interventions related to decreasing alcohol consumption in heavy drinkers. The study will be conducted online through the Prolific platform.
Detailed description
Participants will be recruited through Prolific. All participants will complete a series of demographic and psychometric questionnaires before beginning the study. Participants will also complete some of the psychometric questionnaires (RCQ, GAD-7, PHQ-9) at the end of the study to track any potential changes. Participants will be pre-screened for their motivation using a modified MTSS (Motivation to Stop Smoking) scale. Participants will also be asked to report their primary source of motivation regarding wanting to quit or reduce drinking, in addition to reporting their main goal regarding alcohol, where the options will be wanting to quit, wanting to reduce drinking, wanting to be more in control of their drinking, and not wanting to quit, reduce, or be more in control of drinking. All participants will also report their alcohol consumption using a timeline followback task with the ability to view both a calendar and a reference image of UK alcohol units. They'll report their alcohol consumption from the week before the study and complete two TLFBs during the study.
Intervention group participants complete daily visual analogue scales of their mood. Control group participants complete daily reports of how many hours they spent online the previous day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionParticipants complete daily mood tracking and weekly timeline followbacks of alcohol use |
| Control | No intervention | –Participants complete daily logs of time spent online and weekly timeline followbacks of alcohol use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Speaking fluent English
- being over 18 years of age
- High completion rates of previous studies on the Prolific platform
- Being located in the United Kingdom
- Consuming over 20 UK units of alcohol per week
Key exclusion criteria (1 listed)
- Having an ongoing mental health condition
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 |
|---|---|---|
| InterventionAlso: Alcohol tracking, Mood tracking, Emotional monitoring, EMADaily mood tracking tasks | Behavioural | Intervention |
Primary outcome
TLFB
Time frame: 3 weeks
Timeline followbacks completed of consumed alcohol units reflecting alcohol units (UK) of alcohol consumed before the study and throughout the study
3 secondary outcomes
GAD-7
Time frame: 3 weeks
PHQ-9
Time frame: 3 weeks
RCQ
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No. Study protocol, statistical analysis plan, informed consent form will be shared
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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.
Ilona S Myllyniemi, PhD Student contact
Valerie Voon, PhD, MD study director
University of Cambridge
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Alcohol Abuse and Alcohol Drinking, run by Ilona Myllyniemi.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Voon, PhD, MD (01223768504 ext. +44, vv247@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLFB (time frame: 3 weeks). 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 17 May 2024.