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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06419647
Other study ID # MOODSTUDYALCOHOL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date December 2025

Study information

Verified date May 2024
Source University of Cambridge
Contact Valerie Voon, PhD, MD
Phone 01223768504
Email vv247@cam.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Having an ongoing mental health condition

Study Design


Intervention

Behavioral:
Intervention
Daily mood tracking tasks

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ilona Myllyniemi University of Cambridge

Outcome

Type Measure Description Time frame Safety issue
Primary TLFB Timeline followbacks completed of consumed alcohol units reflecting alcohol units (UK) of alcohol consumed before the study and throughout the study 3 weeks
Secondary GAD-7 Comparison of potential changes in GAD-7 score before and after study 3 weeks
Secondary PHQ-9 Comparison of potential changes in PHQ-9 score before and after study 3 weeks
Secondary RCQ Comparison of potential changes in Readiness to Change score and Stage of Change destination before and after study 3 weeks
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