Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001320549
Ethics application status
Approved
Date submitted
19/09/2015
Date registered
2/12/2015
Date last updated
4/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
WorryTime: A randomized controlled trial comparing smartphone and paper and pencil delivery of worry postponement in young Australians aged 16-25 years
Scientific title
In a sample of young Australians aged 16-25 years, does smartphone delivery, compared with paper and pencil delivery of the stimulus control technique of worry postponement, improve engagement with and ease of use of the technique and thereby improve levels of worry to a greater extent?
Secondary ID [1] 287483 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Worry 296226 0
Anxiety 296227 0
Condition category
Condition code
Mental Health 296496 296496 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be asked to use the stimulus control technique of worry postponement via a smartphone application called WorryTime for 7 days. The technique invites users to postpone worries they experience during the day and worry about them at a set time period each day, usually in the evening. During the day users make a brief note of their worry in the application and then attempt to continue with what they were doing. When the designated worry time arrives (the application provides a reminder alarm), the user reviews the list of worries generated during the day. Worries that no longer bother the user can be dismissed (via a swipe action on the application), allowing them to focus their attention on the remaining active worries. Users are encouraged to engage in problem solving to assist them during their scheduled worry time. When the worry time window elapses (time period is set by the user), users are again encouraged to continue with their day.
Intervention code [1] 292866 0
Prevention
Intervention code [2] 292867 0
Behaviour
Intervention code [3] 293368 0
Treatment: Devices
Comparator / control treatment
The comparator group will be asked to use the same worry postponement technique for 7 days, but using the traditional method of a paper and pencil diary. Participants in this group will record worries by hand in their diary and also to participate in the scheduled worry time (no reminders provided). They are asked to cross out any worries that are no longer bothering them and focus on the active worries, as in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 296125 0
Engagement with the technique, as measured by:
daily attempts to postpone worry (yes/no). Participant self report via daily text message survey for both groups and recorded via the smartphone application for those in the smart phone group.
Timepoint [1] 296125 0
Days 1 through 7
Primary outcome [2] 296760 0
Engagement with the technique, as measured by:
Number of worry entries recorded per day, Participant self report via daily text message survey for both groups and recorded via the smartphone application for those in the smart phone group.
Timepoint [2] 296760 0
Days 1 through 7
Primary outcome [3] 296761 0
Engagement with the technique, as measured by:
Daily adherence to scheduled worry time (yes/no). Participant self report via daily text message survey for both groups and recorded via the smartphone application for those in the smart phone group.
Timepoint [3] 296761 0
Days 1 through 7
Secondary outcome [1] 317557 0
User satisfaction with the technique as measured by self report questions about the perceived helpfulness and level of satisfaction with the technique. These questions were designed specifically for the study.
Timepoint [1] 317557 0
Day 7 for all participants and also day 35 for participants who continued to use the technique after the intervention period.
Secondary outcome [2] 317558 0
Ease of use of the technique as measured by self report 5-point likert scale question about how easy the participant found the technique to use.
Timepoint [2] 317558 0
Day 7 for all participants and also day 35 for participants who continued to use the technique after the intervention period.
Secondary outcome [3] 317559 0
Clinical outcomes as measured by:
- Generalised Anxiety Disorder 7-item scale (GAD-7)
Timepoint [3] 317559 0
Days 1, 7 and 35
Secondary outcome [4] 319281 0
Engagement with the technique, as measured by:
- extended engagement measures (at the end of the 7 day intervention period, participants are asked to estimate how frequently they engaged with the technique over the 7 days
Timepoint [4] 319281 0
Day 7
Secondary outcome [5] 319282 0
Extended engagement with the technique:
At the one month follow up, they are asked how frequently they engaged with the technique in the month following the intervention period (participants are encouraged to continue using the technique after the intervention).
Timepoint [5] 319282 0
Day 35
Secondary outcome [6] 319283 0
Clinical outcomes as measured by:
- Penn State Worry Questionnaire (PSWQ)
Timepoint [6] 319283 0
Days 1, 7 and 35
Secondary outcome [7] 319284 0
Clinical outcomes as measured by:
- Sheehan Disability Scale (SDS)
Timepoint [7] 319284 0
Days 1, 7 and 35

Eligibility
Key inclusion criteria
Participants must meet the following criteria to be included in the study:
- be aged between 16 and 25 years (inclusive)
- have sufficient English comprehension in order to complete the surveys
- be located in Australia
- have daily access to a smartphone that is compatible with the WorryTime application
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- outside of specified age range
- located outside of Australia
- insufficient English comprehension
- lacks daily access to a compatible smartphone
- does not provide informed consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Participants will be randomly allocated to groups using the online survey system Qualtrics randomisation function.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2016
Actual
15/02/2016
Date of last participant enrolment
Anticipated
29/02/2016
Actual
21/03/2016
Date of last data collection
Anticipated
Actual
9/05/2016
Sample size
Target
200
Accrual to date
Final
475
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292059 0
Charities/Societies/Foundations
Name [1] 292059 0
the Grace and Emilio Foundation
Country [1] 292059 0
Australia
Funding source category [2] 292078 0
Government body
Name [2] 292078 0
Lotterywest
Country [2] 292078 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
ReachOut.com
Address
ReachOut Australia Ground Floor 97 Church Street Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 290734 0
University
Name [1] 290734 0
Curtin University
Address [1] 290734 0
Kent St, Bentley WA 6102, Australia
Country [1] 290734 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293544 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 293544 0
Ethics committee country [1] 293544 0
Australia
Date submitted for ethics approval [1] 293544 0
20/08/2015
Approval date [1] 293544 0
21/10/2015
Ethics approval number [1] 293544 0
HR201/2015

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

Contacts
Principal investigator
Name 60382 0
Dr Jonathan Hallet
Address 60382 0
School of Public Health, Faculty of Health Sciences, Curtin University
Building 400, Room 473
GPO Box U1987, Perth, Western Australia, Australia, 6845
Country 60382 0
Australia
Phone 60382 0
+61 08 92667021
Fax 60382 0
Email 60382 0
[email protected]
Contact person for public queries
Name 60383 0
Atari Metcalf
Address 60383 0
ReachOut Australia Level 2, Building B, 35 Saunders street, Pyrmont, NSW, 2009
Country 60383 0
Australia
Phone 60383 0
+61 02 8029 7708
Fax 60383 0
Email 60383 0
[email protected]
Contact person for scientific queries
Name 60384 0
Atari Metcalf
Address 60384 0
ReachOut Australia Level 2, Building B, 35 Saunders street, Pyrmont, NSW, 2009
Country 60384 0
Australia
Phone 60384 0
+61 02 8029 7708
Fax 60384 0
Email 60384 0
[email protected]

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
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