Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12614001173684 |
Date of registration:
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07/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Recharge: an app-based intervention for young men to improve wellbeing.
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Scientific title:
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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:
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09/03/2015 |
Target sample size:
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400 |
Recruitment status: |
Recruiting |
URL:
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https://anzctr.org.au/ACTRN12614001173684.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Ireland
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Contacts
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Name:
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Dr Kathryn McCabe
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Address:
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Brain & Mind Research Institute
94 Mallet St Campus
The University of Sydney
NSW 2006
Australia |
Telephone:
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+61 2 91144155 |
Email:
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kathryn.mccabe@sydney.edu.au |
Affiliation:
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Name:
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Dr Kathryn McCabe
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Address:
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Brain & Mind Research Institute
94 Mallet St Campus
The University of Sydney
NSW 2006
Australia |
Telephone:
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+61 2 91144155 |
Email:
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kathryn.mccabe@sydney.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Mental Health - Other mental health disorders
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Mental health; Mental health
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Intervention(s)
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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.
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Primary Outcome(s)
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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).]
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Secondary Outcome(s)
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Brief Resilience Coping Scale
[Measured at 3-, 6- and 12 months post intervention.]
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K10 measure of psychological distress. [Measured at 3-, 6- and 12-months post intervention.]
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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. ]
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Oxford Happiness Questionnaire
[Measured at 3-, 6- and 12-months post intervention. ]
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Source(s) of Monetary Support
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Young & Well Cooperative Research Centre
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Ethics review
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Status: Approved
Approval date:
Contact:
University College Cork
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Status: Approved
Approval date:
Contact:
University of Sydney Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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