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Trial registered on ANZCTR


Registration number
ACTRN12618000010291
Ethics application status
Approved
Date submitted
11/12/2017
Date registered
10/01/2018
Date last updated
2/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised control trial to evaluating the effectiveness of the Hello Sunday Morning "Daybreak" program in reducing alcohol use by adults
Scientific title
Randomised control trial evaluating the effectiveness of the Hello Sunday Morning "Daybreak" program in reducing alcohol use by adults
Secondary ID [1] 292185 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
'at-risk' alcohol use 303658 0
Condition category
Condition code
Mental Health 303044 303044 0 0
Addiction
Public Health 304099 304099 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daybreak is a program by Hello Sunday Morning for people looking to change their relationship with alcohol. It allows them to set a goal, reflect on their mood, and engage with peer support.
Daybreak helps people to change their relationship with alcohol in four ways:
1) Weekly Check-in’s: Daybreak supports members in a self-reflection process to discover their inner drivers. Daybreak uses a set of self-report questionnaires that are designed to help people uncover their intrinsic motivators for change.
2) Peer support: Daybreak connects members to the Daybreak Community, a channel to immediate empathy, problem-solving, and accountability. It is a vibrant community with members that care for each other, help each other navigate tough times, and keep each other in check.
3) Behavioural Experiments: Daybreak encourages members to take “experiments”, and reflect on their learnings. Designed by the in house Clinical Team, these experiments are founded in Cognitive Behavioural Therapy techniques, Motivational Interviewing and Acceptance and Commitment Therapy techniques. There are a range of "experiments" across five areas including Mindfulness, Connectedness, Resilience, Situational Strategies and Health. Mindfulness experiments help members learn how to be in-the-moment and recognize when a “drinking trigger” has been activated. The connectedness experiments help them to connect with others in a meaningful and healthy way without alcohol. The resilience experiments teach them how to bounce back from negative experiences and lapses. The situational experiments provide strategies for a range of common trigger situations. Lastly, the health experiments assist members in establishing good fitness routines, good eating and sleeping habits and general health strategies to help with regulating mood.
4) Health Coaches: Health Coaches are experienced specialists in behaviour change who have backgrounds in health, mental health, and psychology. Health coaches partner with members to help them set and reach goals for satisfying and healthy lives. The coaching service is conducted via real-time chat based messaging on a secure platform. Health Coaches again use Cognitive Behavioural Therapy techniques, Motivational Interviewing and Acceptance and Commitment Therapy techniques, however are able to tailor this support to the member’s needs. Health Coaches are also able to troubleshoot with members when they have difficulty with particular experiments or strategies they are trying.

In the intervention group, participants can request online chat based support. To do so they simply click on a button that says “chat to a coach”. They are then able to chat to their coach for as long as they wish during coaching hours (7am-7pm). The number of interactions is entirely variable and up to the participant. They may send one message and respond to the coaches reply later that day, the following day, etc or engage in an ongoing back and forth conversation. Each participant remains with the same coach over the course of the program. Should a coach be on leave or unwell they are given access to another coach to support them during that time if they would like it. Participants can access the coaching service throughout the 6 months of the trial.
The health coaches meet the requirements of the Department of Health’s, low intensity mental health guidelines and are supervised by a clinical psychologist. Health coaches are trained mental health professionals with a minimum Certificate IV in a mental health or community services discipline
Both intervention and control participants have access to self-guided materials and to the online forum. The intervention group also has access to the coaching service which is conducted via real-time chat based messaging on a secure platform. These are all one-to-one sessions, with no limit on the number of sessions. The duration is only limited by operation hours which are 7am-7pm AEST. Participants may still send messages outside of these hours, however will only receive a response from their coach within that time frame.

Both intervention and control participants are asked to complete a weekly check-in, which will used to measure adherence. In addition, the system also records time spent on the Daybreak program, number of posts, comments, shares - typically these measure show greater engagement than the completion of weekly check-ins.
Intervention code [1] 298339 0
Behaviour
Intervention code [2] 298340 0
Rehabilitation
Comparator / control treatment
Hello Sunday Morning's “Daybreak” program (without online coaching support),

The control group access the Daybreak program (as described above) but without access to online coaches.
Control group
Active

Outcomes
Primary outcome [1] 302418 0
Alcohol Use Disorders Identification Test-Consumption (Items 1, 2 and 3 from the 10 item AUDIT). Change in AUDIT-C score
Timepoint [1] 302418 0
baseline, 1, 3 and 6 months. The primary timepoint is change from baseline to 6 months.
Secondary outcome [1] 335909 0
Kessler 10 - change in K-10 score
Timepoint [1] 335909 0
baseline, 1, 3 and 6 months
Secondary outcome [2] 335913 0
Change in alcohol consumption assessed as standard drinks (Australian drinks equals 10g alcohol) via self-report 7 day drinking diary.
Timepoint [2] 335913 0
baseline, 1, 3 and 6 months
Secondary outcome [3] 335914 0
Kessler's Days out of role: change in days out of role
Timepoint [3] 335914 0
baseline, 1, 3 and 6 months
Secondary outcome [4] 335915 0
EURHIS Quality of life - change in EUROHIS score
Timepoint [4] 335915 0
baseline, 1, 3 and 6 months
Secondary outcome [5] 335916 0
Pittsburgh Sleep Quality score (single item) change in score
Timepoint [5] 335916 0
baseline, 1, 3 and 6 months
Secondary outcome [6] 335917 0
Godlin leisure time exercise questionnaire (3 items) change in excercise score
Timepoint [6] 335917 0
baseline, 1, 3 and 6 months
Secondary outcome [7] 335918 0
Use of health resources
(study specific survey - checklist of health services used in the last 8 weeks - descriptive data)
Timepoint [7] 335918 0
baseline, 1, 3 and 6 months
Secondary outcome [8] 335919 0
CORE survey
19 item checklist of adverse events due to alcohol use (modified to remove "drugs" from the lead in text and from 1 item: "Thought I might have a drinking or other drug problem"))
Timepoint [8] 335919 0
Baseline and 6 months

Eligibility
Key inclusion criteria
New registrant to Daybreak
Aged 18 years or older
AUDIT score >7 ('at risk' alcohol use)
Australian resident
email address + internet access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude those who have every received treatment for cardiovascular disease, due to the risks for this latter group..

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Fully automated randomisation implemented through the Hello Sunday Morning software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Given the large sample, simple fully automated randomisation will be implemented,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are unaware of any prior studies using social networks for alcohol reduction, but for other behaviours, the reported changes are small but not significant. The effect sizes for online screening and brief intervention (SBI) alcohol interventions are in the range d = 0.3 - 0.4 at 6 months, with few studies having longer periods of follow-up. Based on a small estimated effect of f = .10 (equivalent of d = 0.2) at 6 months, with a correlation between repeated measures of r = .5, we will require 60 people per group for the main analysis. Given the interest in the effectiveness of interventions by gender and for those with ‘probable dependence’ (assessed via the AUDIT i.e. score 20+), the objective will be to recruit about 60 people in the smallest cell(s). From demographic data with about 50% of the population likely to be in the probable dependence AUDIT category and 40% being male, to obtain about 60 people in this cell will require 300 people per study arm Hello Sunday Morning (600 in total). To allow for attrition, the target will be to recruit 467 per arm (N=934), with 35% lost to follow-up.

We will evaluate the primary and secondary outcome using an intention-to-treat approach with the effect of the intervention on each measure being assessed via a time by group interaction. Due to the correlated data arising from the repeated measures, we will employ a multi-level mixed effects regression model with a random intercept term. This will control for clustering of variance within individuals over the repeated measures. For continuous data, we will use an unstructured correlation matrix with a normal distribution and identity link. For other types of data (e.g. count, categorical) multinomial, Poisson or negative binomial distribution will be used with their appropriate link functions..

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2018
Actual
Date of last participant enrolment
Anticipated
4/04/2018
Actual
Date of last data collection
Anticipated
4/10/2018
Actual
Sample size
Target
934
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296705 0
Charities/Societies/Foundations
Name [1] 296705 0
Hello Sunday Morning
Country [1] 296705 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth
Western Australia, 6102

GPO Box U1987, Perth
Western Australia, 6845
Country
Australia
Secondary sponsor category [1] 295690 0
None
Name [1] 295690 0
Address [1] 295690 0
Country [1] 295690 0
Other collaborator category [1] 279602 0
University
Name [1] 279602 0
Associate Professor Michael Schaub
Address [1] 279602 0
ISGF
Schweizer Institut für Sucht- und Gesundheitsforschung
Konradstrasse 32
Postfach
8031 Zürich
Country [1] 279602 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297933 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 297933 0
Ethics committee country [1] 297933 0
Australia
Date submitted for ethics approval [1] 297933 0
27/07/2017
Approval date [1] 297933 0
11/12/2017
Ethics approval number [1] 297933 0
HREC2017-0855

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

Contacts
Principal investigator
Name 75498 0
Dr Robert Tait
Address 75498 0
National Drug Research Institute
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102

GPO Box U1987, Perth WA 6845
Country 75498 0
Australia
Phone 75498 0
+61892661610
Fax 75498 0
+61892661611
Email 75498 0
robert.tait@curtin.edu.au
Contact person for public queries
Name 75499 0
Robert Tait
Address 75499 0
National Drug Research Institute
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102

GPO Box U1987, Perth WA 6845
Country 75499 0
Australia
Phone 75499 0
+61892661610
Fax 75499 0
+61892661611
Email 75499 0
robert.tait@curtin.edu.au
Contact person for scientific queries
Name 75500 0
Robert Tait
Address 75500 0
National Drug Research Institute
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102

GPO Box U1987, Perth WA 6845
Country 75500 0
Australia
Phone 75500 0
+61892661610
Fax 75500 0
+61892661611
Email 75500 0
robert.tait@curtin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.