Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers

May 13, 2024 updated by: Ilona Myllyniemi
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Valerie Voon, PhD, MD
  • Phone Number: +44 01223768504
  • Email: vv247@cam.ac.uk

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants complete daily mood tracking and weekly timeline followbacks of alcohol use
Behavioral: Intervention
Daily mood tracking tasks
Other Names:
  • EMA
  • Alcohol tracking
  • Mood tracking
  • Emotional monitoring
No Intervention: Control
Participants complete daily logs of time spent online and weekly timeline followbacks of alcohol use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GAD-7
Time Frame: 3 weeks
Comparison of potential changes in GAD-7 score before and after study
3 weeks
PHQ-9
Time Frame: 3 weeks
Comparison of potential changes in PHQ-9 score before and after study
3 weeks
RCQ
Time Frame: 3 weeks
Comparison of potential changes in Readiness to Change score and Stage of Change destination before and after study
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ilona Myllyniemi

Collaborators

University of Cambridge

Investigators

  • Study Director: Valerie Voon, PhD, MD, University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOODSTUDYALCOHOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Drinking

Clinical Trials on Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe