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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614001173684
Date of registration: 07/11/2014
Prospective Registration: Yes
Primary sponsor: Ian Hickie
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?
Date of first enrolment: 09/03/2015
Target sample size: 400
Recruitment status: Recruiting
URL:  https://anzctr.org.au/ACTRN12614001173684.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Australia Ireland
Contacts
Name: Dr Kathryn McCabe   
Address:  Brain & Mind Research Institute 94 Mallet St Campus The University of Sydney NSW 2006 Australia
Telephone: +61 2 91144155
Email: kathryn.mccabe@sydney.edu.au
Affiliation: 
Name: Dr Kathryn McCabe   
Address:  Brain & Mind Research Institute 94 Mallet St Campus The University of Sydney NSW 2006 Australia
Telephone: +61 2 91144155
Email: kathryn.mccabe@sydney.edu.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Residing in Australia or Ireland; English speaking
Exclusion criteria: Residing outside of Australia or Ireland, shiftworkers.

Age minimum: 16 Years
Age maximum: 24 Years
Gender: Males
Health Condition(s) or Problem(s) studied
Mental Health - Other mental health disorders
Mental health;
Mental health
Intervention(s)
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.
Primary Outcome(s)
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).[Baseline and post intervention (6 weeks).]
Secondary Outcome(s)
Brief Resilience Coping Scale
[Measured at 3-, 6- and 12 months post intervention.]
K10 measure of psychological distress. [Measured at 3-, 6- and 12-months post intervention.]
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).
[Measured at 3-, 6- and 12-months post intervention. ]
Oxford Happiness Questionnaire
[Measured at 3-, 6- and 12-months post intervention. ]
Secondary ID(s)
Nil
Source(s) of Monetary Support
Young & Well Cooperative Research Centre
Secondary Sponsor(s)
Tracey Davenport
Ethics review
Status: Approved
Approval date:
Contact:
University College Cork
Status: Approved
Approval date:
Contact:
University of Sydney Human Research Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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