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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000967381p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
9/07/2026
Date registered
Help: Date registered
6/08/2026
Date last updated
Help: Date last updated
6/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
SHADE-Predict: A Pilot Study Exploring Genetic and Digital Predictors of Treatment Response to an eHealth Intervention for Alcohol Use in Adults with Moderate to Hazardous Drinking
Scientific title
SHADE-Predict: A Pilot Study Exploring Genetic and Digital Predictors of Treatment Response to an eHealth Intervention for Alcohol Use in Adults with Moderate to Hazardous Drinking
Additional trial identifiers [1] 317760 0
alcohol intervention
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
moderate to hazardous alcohol use 342793 0
Condition category
Condition code
Mental Health 338917 338917 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention evaluated in this study is the "Self-Help for Alcohol and Depression (SHADE)" program, an evidence-based online intervention for individuals experiencing problematic alcohol use and depressed mood. SHADE comprises of 10 treatment modules that include educational content, interactive exercises, and case vignettes, and is based on Cognitive Behaviour Therapy (CBT), Motivational Enhancement Therapy (MET)/motivational interviewing techniques, and mindfulness-based stress reduction approaches. Participants are encouraged to work through the program independently as a self-help intervention.

The intervention is delivered primarily by the "SHADE", with additional support provided by members of the research team through regular check-in calls. The protocol identifies research staff, including the Research Assistant responsible for coordinating study activities and conducting follow-up calls, with support from other investigators who provide clinical supervision and assistance with participant contact and technical issues. The intervention itself was developed by Professor Frances Kay and is based on established evidence-based psychological treatments for alcohol use problems.

SHADE is delivered online via the internet and can be accessed using a computer or smartphone. It is designed as an individual, self-guided intervention rather than a group-based treatment. Participants are introduced to the program during an in-person baseline appointment and then access the modules remotely throughout the study period.

Participants are granted access to SHADE for 12 weeks (approximately three months). The program contains 10 modules that are designed to be completed at a rate of one module per week. In addition, participants receive fortnightly check-in calls from a member of the research team between weeks 3 and 12 to discuss progress in the program and address any questions or concerns.

The intervention is delivered primarily online in participants’ own environments, wherever they can access the internet. However, participants first attend an in-person baseline assessment at the Hunter Medical Research Institute (HMRI) at week 1 of the study, where they complete study procedures and are set up with the SHADE program and other digital study tools.

Adherence is supported through several strategies. Participants receive fortnightly telephone check-in calls, with SMS reminder messages sent the day before each scheduled call. The study also uses assertive follow-up procedures, including phone calls, text messages, emails, appointment confirmations, and contact with alternate contacts when necessary to encourage retention. Adherence and engagement are monitored through measures such as the number of SHADE logins, number of SHADE modules completed, number of iYarn check-ins completed, and the percentage of days with smartwatch data available.
Intervention code [1] 334692 0
Diagnosis / Prognosis
Intervention code [2] 334693 0
Early detection / Screening
Description of the comparator or control
Based on the protocol, there is no comparator or control condition. This is a single-arm pilot study in which all participants receive access to the SHADE online intervention. The study aims to examine predictors of treatment response and the feasibility and acceptability of study procedures rather than compare SHADE with another treatment, placebo, usual care, or waitlist control group.

As no comparator is included in the study design, there is no separate intervention provider, delivery method, duration, setting, or adherence procedures for a comparator condition. All participants undergo the same study procedures, including access to the SHADE program, use of the iYarn app and smartwatch, and participation in fortnightly check-in calls with the research team.

Therefore, for data extraction purposes, the comparator can be recorded as: None (single-arm pilot study; no control or comparison group).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346132 0
alcohol use- assessed together
Timepoint [1] 346132 0
Baseline at week 1, follow up assessment at week 12
Primary outcome [2] 346134 0
drugs and alcohol - assessed together in this measure
Timepoint [2] 346134 0
Baseline at week 1 and at week 12 (follow up assessment)
Secondary outcome [1] 464705 0
Depression
Timepoint [1] 464705 0
Baseline at week 1 and at week 12 (follow up assessment)
Secondary outcome [2] 465851 0
Acceptability and feasibility of collecting genetic material via saliva tube
Timepoint [2] 465851 0
Entire recruitment period- end of study (this will be a composite assessment where researchers will look at when people are signing up to participate and taking the eligibility assessment.

Eligibility
Key inclusion criteria
1) 18 years of age or older;

2) Current risky alcohol consumption (those who score >3 for women, non-binary, or those who select a different gender identity marker, and >4 for men on the Alcohol Use Disorder Identification Test – Consumption (AUDIT-C);

3) Ability to speak, read, and write in English;

4) Access to a device able to connect to the Internet;

5) Access to a smartphone compatible with the iYarn app

6) Willingness to supply saliva sample for single nucleotide polymorphism (SNP) testing;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1) Current, acute, high risk of suicide. Ineligible participants will be provided with resource options (please see Document H for screening and protocol for high-risk incidents);

2) People who cannot go 30 minutes without food or water prior to genetic sampling;

3) Insufficient English to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Co-investigators Murray, Greco, and Adams, who have previous experience with conducting research analysing genetic SNP analysis, will conduct laboratory analyses of saliva samples to identify key genetic markers relevant to alcohol use disorders. Data captured via the Withing's Scan 2 Watch and iYarn platform is automatically processed, generating variables related to physical activity, sleep, and heart rate. These digital behaviour metrics, genetic markers, together with self-report data collected via daily EMA, at baseline and follow-up, will be incorporated into a series of regression analyses led by CIA Thornton and CI Day. The primary aim of these analyses will be to determine whether personal characteristics (e.g., age, gender, reasons for drinking, other substance use, psychological distress, financial stress, patterns of alcohol use), as well as genetic markers and digital behaviour patterns, can predict participants’ treatment response to SHADE. Treatment response will be operationalised as the change in participants’ AUDIT total score between baseline and the 12-week follow up assessment.

Genetics Data Analysis Plan:

The Illumina Infinitium Human 610 (610-Quad) BeadChip platform will be used to genotype genomic DNA extracted from the saliva of all consenting participants as per standard manufacturer protocols. Individual samples genotyped by the SNP array will be subject to pre-imputation quality control by removing: 1) SNPs and individuals with high missingness (2%), 2) individuals with mismatched reported and genetic sex, 3) rare variants (minor allele frequency < 1%), 4) SNPs violating Hardy-Weinberg equilibrium, 5) one individual in any pair with high genetic relatedness (second degree relative or greater). Ancestral outliers will then be identified and removed using k-means clustering and the 1000 Genomes reference population as previously described {Reay, William, 2020}. Genome imputation will then be conducted using the Michigan Imputation Servers, after which post-imputation quality control will be conducted to retain SNPs with high imputation confidence (INFO > 0.8), low missingness (< 2%) and common population frequency (minor allele frequency > 1%).
Polygenic risk scores (PRS) for Alcohol Use Disorder will be constructed that aggregate an individual’s cumulative genetic burden across many SNPs into a single metric. The contribution of each SNP to the final score will be weighted using large genome-wide association studies for AUDIT scores previously conducted in the UK Biobank and/or by the Psychiatric Genomics Consortium. PRS partitioned within pharmacologically actionable gene sets, termed Pharmagenic Enrichment Scores, will also be derived as pre previous work in the Cairns laboratory {Reay, William R., 2020; Reay, William, 2020}.
These scores will be utilised as explanatory variables in regression models assessing the effect of genetic risk on alcohol use phenotypes, conditioned on appropriate covariates (e.g. age, sex, genetic principal components). Additionally, multidimensional Grade of Membership clustering methods will be used to derive subgroups based on data collected during Baseline Assessment. This includes previous substance use, medical history including comorbidities and demographics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322299 0
University
Name [1] 322299 0
This study is supported by funding from the Janice Leggett Bequest (G2401814) awarded to Professor Kay-Lambkin, Professor Dayas, Dr Campbell, Dr Thornton, Dr Rich and Dr Sampson at the University of Newcastle.
Country [1] 322299 0
Australia
Funding source category [2] 322395 0
Government body
Name [2] 322395 0
NHMRC Centre of Research Excellence in Depression Treatment Precision awarded to Dr Thornton.
Country [2] 322395 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 325216 0
None
Name [1] 325216 0
Address [1] 325216 0
Country [1] 325216 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320810 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 320810 0
Ethics committee country [1] 320810 0
Australia
Date submitted for ethics approval [1] 320810 0
22/06/2026
Approval date [1] 320810 0
Ethics approval number [1] 320810 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151714 0
Dr Louise Thornton
Address 151714 0
The University of Newcastle at Lot 1 Kookaburra Cct, New Lambton Heights, NSW 2305
Country 151714 0
Australia
Phone 151714 0
+61 02 4042 0993
Fax 151714 0
Email 151714 0
[email protected]
Contact person for public queries
Name 151715 0
Louise Thornton
Address 151715 0
The University of Newcastle at Lot 1 Kookaburra Cct, New Lambton Heights, NSW, 2305
Country 151715 0
Australia
Phone 151715 0
+61 02 4042 0993
Fax 151715 0
Email 151715 0
[email protected]
Contact person for scientific queries
Name 151716 0
Louise Thornton
Address 151716 0
The University of Newcastle at Lot 1 Kookaburra Cct, New Lambton Heights, NSW, 2305
Country 151716 0
Australia
Phone 151716 0
+61 02 4042 0993
Fax 151716 0
Email 151716 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Document A- SHADE-Predict Protocol.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.