A Mobile Phone Self-Monitoring Tool to Increase Emotional Self-Awareness and Reduce Depression in Young People (mobiletype)

• ClinicalTrials.gov Identifier: NCT00794222
• Recruitment Status: Unknown
• First Posted: November 20, 2008
• Last Update Posted: November 20, 2008
• Sponsor: Murdoch Childrens Research Institute
• Information provided by: Murdoch Childrens Research Institute

Tracking Information

• First Submitted Date: November 19, 2008
• First Posted Date: November 20, 2008
• Last Update Posted Date: November 20, 2008
• Study Start Date: February 2009
• Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 19, 2008): Depressive symptoms [ Time Frame: Pre-, post-monitoring, 6-week follow up & 6 month follow-up ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 19, 2008)

• Emotional Self-awareness [ Time Frame: Pre-, post-monitoring, 6 week and 6 month follow up ]
• Detection of mental health problems [ Time Frame: Pre-, post-monitoring, 6 week and 6 month follow up ]
• Pathways to care [ Time Frame: Pre-, post-monitoring, 6 week and 6 month follow up ]
• Patient's satisfaction with their GP [ Time Frame: Pre-, post-monitoring, 6 week and 6 month follow up ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Mobile Phone Self-Monitoring Tool to Increase Emotional Self-Awareness and Reduce Depression in Young People
• Official Title: A Randomised Controlled Trial Investigating a Mobile Phone Self-Monitoring Tool (Mobiletype) to Increase Emotional Self-Awareness and Reduce Depressive Symptoms in Young People.

Brief Summary

The mobiletype program is a mental health assessment and monitoring tool that runs on mobile phones.

The program assesses the general mental health of young people in real-time and transmits this data to a website to be reviewed by their general practitioner (GP) in consultation with their patient. The website consists of individualised feedback reports for each participant, and graphical displays of the monitoring data. The primary aims of the current project are to examine: (1) whether the process of self-monitoring via the mobiletype program increases young people's awareness of their mood and reduces depressive symptoms and (2) whether emotional self-awareness mediates the relationship between self-monitoring and depressive symptoms.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Depression

Intervention

Device: Mobile Tracking Young People's Experiences (mobiletype)

A mobile phone self-monitoring program, based on momentary sampling techniques, that prompts young people to complete it four times a day. The program asks several questions about daily activities, mood, stress, eating and exercise.

Study Arms

• Experimental: Mood monitoring
  The mobiletype monitoring intervention group will monitor their current activities, current mood, responses to negative mood, any recent stressors and coping strategies. Other activities monitored include eating patterns, exercise patterns, quantity and quality of sleep and alcohol and cannabis use.
  Intervention: Device: Mobile Tracking Young People's Experiences (mobiletype)
• No Intervention: Comparison monitoring program

  The mobiletype monitoring comparison group will monitor their current activities, eating patterns, exercise patterns, quantity and quality of sleep and alcohol and cannabis use.

  This program excludes questions about mood, stress and coping strategies.

Publications *

• Reid SC, Kauer SD, Hearps SJ, Crooke AH, Khor AS, Sanci LA, Patton GC. A mobile phone application for the assessment and management of youth mental health problems in primary care: health service outcomes from a randomised controlled trial of mobiletype. BMC Fam Pract. 2013 Jun 19;14:84. doi: 10.1186/1471-2296-14-84.
• Kauer SD, Reid SC, Crooke AH, Khor A, Hearps SJ, Jorm AF, Sanci L, Patton G. Self-monitoring using mobile phones in the early stages of adolescent depression: randomized controlled trial. J Med Internet Res. 2012 Jun 25;14(3):e67. doi: 10.2196/jmir.1858.
• Reid SC, Kauer SD, Hearps SJ, Crooke AH, Khor AS, Sanci LA, Patton GC. A mobile phone application for the assessment and management of youth mental health problems in primary care: a randomised controlled trial. BMC Fam Pract. 2011 Nov 29;12:131. doi: 10.1186/1471-2296-12-131.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 19, 2008): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2010
• Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Aged 14 - 24 years of age
• Proficient English
• Patients must be deemed to have an emotional/mental health concern by their GP or be screened to have at least a mild mental health problem (a score of 16 or above) on the K10 Symptom Scale

Exclusion Criteria:

• Severe psychiatric or medical condition that prevents the person from complying with either the requirements of informed consent or the study protocol.
• Young people referred to a mental health specialist by their GP will be excluded only if they obtain a specialist appointment during the mobiletype study period (2 - 4 weeks).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 24 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00794222
• Other Study ID Numbers: RCH28113; Telstra Foundation: N33E2912
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr Sophie Reid, Murdoch Childrens Research Institute
• Study Sponsor: Murdoch Childrens Research Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sylvia D Kauer, BBSci(Hons); Murdoch Childrens Research Instititue
• Principal Investigator: Sophie C Reid, PhD,MPsych; Murdoch Childrens Research Institute

• PRS Account: Murdoch Childrens Research Institute
• Verification Date: November 2008