## Protocol Section
### Identification Module
**NCT ID:** NCT06419647

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

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

#### Organization Study ID Info
**ID:** MOODSTUDYALCOHOL
#### Organization
**Class:** OTHER
**Full Name:** University of Cambridge
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Cambridge

#### Lead Sponsor

**Class:** OTHER

**Name:** Ilona Myllyniemi

#### Responsible Party

**Investigator Affiliation:** University of Cambridge

**Investigator Full Name:** Ilona Myllyniemi

**Investigator Title:** PhD Student

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Alcohol Abuse

- Alcohol Drinking

- Alcohol Use Disorder

- Alcohol Dependence

- Alcohol Intoxication

**Keywords:**

- Alcohol

- AUD

- Mood tracking

- EMA

- Emotional monitoring

- Alcohol tracking

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 2000

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Intervention

**Label:** Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** Daily mood tracking tasks

**Name:** Intervention

**Other Names:**

- Alcohol tracking

- Mood tracking

- Emotional monitoring

- EMA

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Timeline followbacks completed of consumed alcohol units reflecting alcohol units (UK) of alcohol consumed before the study and throughout the study

**Measure:** TLFB

**Time Frame:** 3 weeks

#### Secondary Outcomes

**Description:** Comparison of potential changes in GAD-7 score before and after study

**Measure:** GAD-7

**Time Frame:** 3 weeks

**Description:** Comparison of potential changes in PHQ-9 score before and after study

**Measure:** PHQ-9

**Time Frame:** 3 weeks

**Description:** Comparison of potential changes in Readiness to Change score and Stage of Change destination before and after study

**Measure:** RCQ

**Time Frame:** 3 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Gender Based:** True

**Gender Description:** Gender options provided are as follows: Male, Female, Non-binary, Transgender man, Transgender woman, Other, Prefer not to say

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** vv247@cam.ac.uk

**Name:** Valerie Voon, PhD, MD

**Phone:** 01223768504

**Phone Ext:** +44

**Role:** CONTACT

**Contact 2:**

**Email:** ism31@cam.ac.uk

**Name:** Ilona S Myllyniemi, PhD Student

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Cambridge

**Name:** Valerie Voon, PhD, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

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

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004327

- Term: Drinking Behavior

- ID: D000019973

- Term: Alcohol-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3783

- Name: Alcoholism

- Relevance: HIGH

- As Found: Alcohol Use Disorder

- ID: M3774

- Name: Alcohol Drinking

- Relevance: HIGH

- As Found: Alcohol Drinking

- ID: M3781

- Name: Alcoholic Intoxication

- Relevance: HIGH

- As Found: Alcohol Intoxication

- ID: M7502

- Name: Drinking Behavior

- Relevance: LOW

- As Found: Unknown

- ID: M21842

- Name: Alcohol-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000437

- Term: Alcoholism

- ID: D000000435

- Term: Alcoholic Intoxication

- ID: D000000428

- Term: Alcohol Drinking

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
