- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06419647
Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers
Study Overview
Status
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Valerie Voon, PhD, MD
- Phone Number: +44 01223768504
- Email: vv247@cam.ac.uk
Study Contact Backup
- Name: Ilona S Myllyniemi, PhD Student
- Email: ism31@cam.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
|
Daily mood tracking tasks
Other Names:
|
|
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
Sponsor
Collaborators
Investigators
- Study Director: Valerie Voon, PhD, MD, University of Cambridge
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOODSTUDYALCOHOL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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