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Trial registered on ANZCTR


Registration number
ACTRN12622001014741
Ethics application status
Approved
Date submitted
14/07/2022
Date registered
19/07/2022
Date last updated
19/07/2022
Date data sharing statement initially provided
19/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot evaluation of an online program to support women's well being
Scientific title
Pilot evaluation of acceptability and feasibility of CIRCUS: An online program to support women's well being
Secondary ID [1] 307569 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 327019 0
alcohol use 327020 0
mental ill health 327021 0
Condition category
Condition code
Mental Health 324194 324194 0 0
Addiction
Mental Health 324195 324195 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CIRCUS is a self-paced, modular, online program designed to improve healthy coping strategies and reduce reliance on unhelpful strategies. CIRCUS was developed by clinical psychologists and is based on principles of cognitive behaviour therapy and motivational enhancement.

There are seven modules, focusing on modifiable health behaviours (sleep, nutrition, exercise and alcohol use) and emotional stressors (low mood, stress and multitasking). Each module includes videos, and detailed behavioural, cognitive and motivational exercises. It is expected that each module will take around 1 hour to complete.

After responding to an online advertisement, participants will be asked to provide informed consent and complete a baseline assessment. Following this, they will be given access to the program via a weblink.

Participants will have access to the program for 3-weeks. They will be able to access any or all of the modules in the order they prefer and can re-visit modules.

Examples of exercises include thought monitoring, pleasant event scheduling and decisional balance.

Engagement with the website will be evaluated using website analytics. These will report number of log in occasions and date of first and last accessing the site.
Intervention code [1] 324028 0
Lifestyle
Intervention code [2] 324029 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332010 0
Acceptability measured by survey responses to 5-point Likert scales designed specifically for this study and open ended written responses about the experience of using the program. Participants will be asked about satisfaction with the different modules, with elements of CIRCUS formatting, and overall experience of using the program.
Timepoint [1] 332010 0
At completion of the intervention period, 3-weeks after baseline.
Primary outcome [2] 332011 0
Feasibility will be measured by website analytics. Specifically analytics will provide evidence of number of logins, and date of first and last login.
Timepoint [2] 332011 0
At completion of the intervention period, 3-weeks after baseline.
Primary outcome [3] 332029 0
Feasibility will be measured by recruitment and follow-up retention rates. Recruitment will be measured by comparing number of "clicks" on the information statement to the number providing informed consent and then completing baseline assessment.

Follow-up retention rates will be a comparison of baseline to 3-week and 8-week assessment completion rates.
Timepoint [3] 332029 0
Assessed at completion of 8-week follow-up.
Secondary outcome [1] 411896 0
Alcohol Use Disorders (AUDIT)
Timepoint [1] 411896 0
At completion of the intervention period, 3-weeks after baseline and follow-up at 8-weeks post-baseline.
Secondary outcome [2] 411897 0
Depression Anxiety Stress Scales (DASS-21)
Timepoint [2] 411897 0
At completion of the intervention period, 3-weeks after baseline and follow-up at 8-weeks post-baseline.
Secondary outcome [3] 411898 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 411898 0
At completion of the intervention period, 3-weeks after baseline and follow-up at 8-weeks post-baseline.
Secondary outcome [4] 411899 0
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Timepoint [4] 411899 0
At completion of the intervention period, 3-weeks after baseline and follow-up at 8-weeks post-baseline.
Secondary outcome [5] 411900 0
Diet (Starting the Conversation) is a brief 8-item assessment of dietary intake (quantity of fruit and vegetable intake each day and frequency of dietary intake of a range of food groups.)
e.g. "How many times a week did you eat fast food meals or snack?" with multiple choice responses - "Less than 1 time" "1-3 times" "4 or more times".
Timepoint [5] 411900 0
At completion of the intervention period, 3-weeks after baseline and follow-up at 8-weeks post-baseline.

Eligibility
Key inclusion criteria
Women aged 18 years or older who are Australian residents, fluent in English, and have access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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
Primary outcomes are acceptability and feasibility of the intervention. Results of these outcomes will be descriptive.

Secondary outcomes are changes in key health areas of sleep, nutrition, exercise and alcohol intake. This will be analysed quantitatively by comparing pre- and post-intervention data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
25/01/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311842 0
University
Name [1] 311842 0
University of Newcastle
Country [1] 311842 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan, 2308
NSW
Country
Australia
Secondary sponsor category [1] 313339 0
None
Name [1] 313339 0
Address [1] 313339 0
Country [1] 313339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311285 0
University of Newcastle, Human Research Ethics Committee
Ethics committee address [1] 311285 0
University of Newcastle HREC
University Drive
Callaghan 2308
NSW
Ethics committee country [1] 311285 0
Australia
Date submitted for ethics approval [1] 311285 0
14/04/2022
Approval date [1] 311285 0
14/07/2022
Ethics approval number [1] 311285 0
H-2022-0122

Summary
Brief summary
This study will determine the feasibility and acceptability (uptake, satisfaction) of the online CIRCUS program; a gender-tailored alcohol and healthy lifestyle program for women. The primary endpoint will be 3-weeks post baseline. The aims of this study are to determine if women are willing and able to use CIRCUS, an eHealth program, for 3-weeks, and to assess their satisfaction with the program. Primary outcomes will focus on recruitment, retention, and adherence to study parameters. Secondary outcomes will examine key health behaviours of alcohol use, nutrition, exercise, sleep and mental well being.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120570 0
Dr Sally Hunt
Address 120570 0
School of Psychological Sciences
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 120570 0
Australia
Phone 120570 0
+61 2 4985 4305
Fax 120570 0
Email 120570 0
[email protected]
Contact person for public queries
Name 120571 0
Sally Hunt
Address 120571 0
School of Psychological Sciences
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 120571 0
Australia
Phone 120571 0
+61 2 4985 4305
Fax 120571 0
Email 120571 0
[email protected]
Contact person for scientific queries
Name 120572 0
Sally Hunt
Address 120572 0
School of Psychological Sciences
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 120572 0
Australia
Phone 120572 0
+61 2 4985 4305
Fax 120572 0
Email 120572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant demographics, DASS-21, AUDIT, IPAQ-SF, Starting the Conversation, PSIQ measured at baseline, 3-weeks and 8-weeks post-baseline.

Acceptability and feasibility measured at 3-weeks and 8-weeks post-baseline.
When will data be available (start and end dates)?
Start date - June 2023
End date - 5 years after publication
Available to whom?
Determined on a case-by-case basis at the discretion of chief investigator.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data will be stored in an online repository. Please contact Dr Sally Hunt [email protected] to access this data when it is available at a later date.


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.