NCT06419647

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Status
not yet recruiting

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

Study Start

First participant enrolled

May 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

May 13, 2024

Last Update Submit

May 13, 2024

Conditions

Keywords

AlcoholAUDMood trackingEMAEmotional monitoringAlcohol tracking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • GAD-7

    3 weeks

  • PHQ-9

    3 weeks

  • RCQ

    3 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants complete daily mood tracking and weekly timeline followbacks of alcohol use

Behavioral: Intervention

Control

NO INTERVENTION

Participants complete daily logs of time spent online and weekly timeline followbacks of alcohol use

Interventions

InterventionBEHAVIORAL

Daily mood tracking tasks

Also known as: Alcohol tracking, Mood tracking, Emotional monitoring, EMA
Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender options provided are as follows: Male, Female, Non-binary, Transgender man, Transgender woman, Other, Prefer not to say
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having an ongoing mental health condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AlcoholismAlcohol DrinkingAlcoholic Intoxication

Interventions

MethodsEthanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative TechniquesAlcoholsOrganic Chemicals

Study Officials

  • Valerie Voon, PhD, MD

    University of Cambridge

    STUDY DIRECTOR

Central Study Contacts

Valerie Voon, PhD, MD

CONTACT

Ilona S Myllyniemi, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 17, 2024

Study Start

May 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Study protocol, statistical analysis plan, informed consent form will be shared