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Trial registered on ANZCTR


Registration number
ACTRN12614001173684
Ethics application status
Approved
Date submitted
21/10/2014
Date registered
7/11/2014
Date last updated
16/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Recharge: an app-based intervention for young men to improve wellbeing.
Scientific title
In young men (aged 16-24 years) does a phone app-based intervention targeting the regulation of the sleep/wake cycle, compared to phone apps monitoring mood or providing health information, improve wellbeing?
Secondary ID [1] 285102 0
Nil
Universal Trial Number (UTN)
U1111-1159-9964
Trial acronym
YMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 292654 0
Condition category
Condition code
Mental Health 292967 292967 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A phone app-based intervention targeting the regulation of the sleep/wake cycle. The participant sets target sleep, wake and exercise targets that encourage them to wake within 2 hours of sunrise and set a bed time 16 hours after this time. In addition, early morning daylight exposure, morning physical activity and overall increased physical activity are encouraged and monitored (with feedback) during the intervention. Participants are encouraged to use the app 4 times a day with an overall daily use of approximately 10 minutes. However, they are able to use the app as frequently as they choose. The intervention duration is 6 weeks, with 4 weeks of active intervention and a 2 week maintenance phase. Participants are provided with a unique login to the app and adherence is monitored using event logs and post intervention questionnaire items.
Intervention code [1] 289949 0
Prevention
Intervention code [2] 289950 0
Lifestyle
Comparator / control treatment
Participants will be randomly allocated to a phone app designed to monitor and chart subjective mood ratings or a phone app providing health information.
Control group
Active

Outcomes
Primary outcome [1] 292824 0
Mental health and wellbeing is assessed using the % of Somatic and Psychological HEalth REport (SPHERE-12) scores that meet PSYCH, SOMA and PSYCH/SOMA threshold (PSYCH=PSYCH score>=2; SOMA= SOMA >=3; PSYCH/SOMA=PSYCH score>=2 and SOMA >=3).
Timepoint [1] 292824 0
Baseline and post intervention (6 weeks).
Secondary outcome [1] 309758 0
Mental health and wellbeing is assessed using the % of Somatic and Psychological HEalth REport (SPHERE-12) scores that meet PSYCH, SOMA and PSYCH/SOMA threshold (PSYCH=PSYCH score>=2; SOMA= SOMA >=3; PSYCH/SOMA=PSYCH score>=2 and SOMA >=3).
Timepoint [1] 309758 0
Measured at 3-, 6- and 12-months post intervention.
Secondary outcome [2] 309759 0
Oxford Happiness Questionnaire
Timepoint [2] 309759 0
Measured at 3-, 6- and 12-months post intervention.
Secondary outcome [3] 311198 0
Brief Resilience Coping Scale
Timepoint [3] 311198 0
Measured at 3-, 6- and 12 months post intervention.
Secondary outcome [4] 311199 0
K10 measure of psychological distress.
Timepoint [4] 311199 0
Measured at 3-, 6- and 12-months post intervention.

Eligibility
Key inclusion criteria
Residing in Australia or Ireland; English speaking
Minimum age
16 Years
Maximum age
24 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residing outside of Australia or Ireland, shiftworkers.

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)
Participants who meet inclusion criteria for the study will be automatically randomised to the experimental or control conditions using a simple computer generated randomisation sequence following completion of consent procedures and baseline questionnaire items.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified based on location (Australia/Ireland).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome measure for the study is the SPHERE-12. Estimates of sample size were based on the expectancy that 65% of subjects using the experimental condition (Recharge app) would have a successful outcome (based on SPHERE-12) compared to 25% of those using the control app conditions (mood monitor app; health information app). Primary statistical analysis will be conducted with all participants who complete randomisation. Mixed models repeated measures ANOVA, with measurement occasion as a within groups factor and intervention condition as a between groups factor will be used to examine primary measures of outcome. Planned contrasts will be used to compare intervention and control groups immediately post intervention and at 3-, 6- and 12-month follow-up. Logistic and linear regressions will be used to examine differences between conditions on baseline variables, and logistic regressions will be used to assess the effect of the intervention on participant dropout as well as to investigate predictors of missingness (completers/non-completers) post intervention and at follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/11/2014
Actual
9/03/2015
Date of last participant enrolment
Anticipated
7/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6271 0
Ireland
State/province [1] 6271 0

Funding & Sponsors
Funding source category [1] 289709 0
Other
Name [1] 289709 0
Young & Well Cooperative Research Centre
Country [1] 289709 0
Australia
Primary sponsor type
Individual
Name
Ian Hickie
Address
Brain & Mind Research Institute
The University of Sydney
94 Mallett St
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 288405 0
Individual
Name [1] 288405 0
Tracey Davenport
Address [1] 288405 0
Brain & Mind Research Institute
The University of Sydney
94 Mallett St
Camperdown NSW 2050
Country [1] 288405 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291888 0
University College Cork
Ethics committee address [1] 291888 0
Lancaster Hall
6 Little Hanover Street
Cork
Ethics committee country [1] 291888 0
Ireland
Date submitted for ethics approval [1] 291888 0
Approval date [1] 291888 0
19/08/2013
Ethics approval number [1] 291888 0
ECM 4 (h) 03/09/13
Ethics committee name [2] 291891 0
University of Sydney Human Research Ethics Committee
Ethics committee address [2] 291891 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia
Ethics committee country [2] 291891 0
Australia
Date submitted for ethics approval [2] 291891 0
Approval date [2] 291891 0
22/02/2013
Ethics approval number [2] 291891 0
2012/2806

Summary
Brief summary
The project will explore the use of mobile phone based app technology to improve the mental health and wellbeing of young men. The RCT will help determine if the intervention is effective with an expected reduction in psychiatric morbidities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50430 0
Prof Ian Hickie
Address 50430 0
Brain & Mind Research Institute
94 Mallet St Campus
The University of Sydney
NSW 2006
Country 50430 0
Australia
Phone 50430 0
+61 2 9351 0810
Fax 50430 0
+61 2 9351 0652
Email 50430 0
[email protected]
Contact person for public queries
Name 50431 0
Kathryn McCabe
Address 50431 0
Brain & Mind Research Institute
94 Mallet St Campus
The University of Sydney
NSW 2006
Country 50431 0
Australia
Phone 50431 0
+61 2 91144155
Fax 50431 0
Email 50431 0
[email protected]
Contact person for scientific queries
Name 50432 0
Kathryn McCabe
Address 50432 0
Brain & Mind Research Institute
94 Mallet St Campus
The University of Sydney
NSW 2006
Country 50432 0
Australia
Phone 50432 0
+61 2 91144155
Fax 50432 0
Email 50432 0
[email protected]

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No Supporting Document Provided



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