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

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ClinicalTrials.gov Identifier: NCT00794222
Recruitment Status : Unknown
Verified November 2008 by Murdoch Childrens Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2008
Last Update Posted : November 20, 2008
Sponsor:
Information provided by:
Murdoch Childrens Research Institute

Tracking Information
First Submitted Date  ICMJE November 19, 2008
First Posted Date  ICMJE November 20, 2008
Last Update Posted Date November 20, 2008
Study Start Date  ICMJE February 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
Depressive symptoms [ Time Frame: Pre-, post-monitoring, 6-week follow up & 6 month follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Mobile Phone Self-Monitoring Tool to Increase Emotional Self-Awareness and Reduce Depression in Young People
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 19, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794222
Other Study ID Numbers  ICMJE RCH28113
Telstra Foundation: N33E2912
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Sophie Reid, Murdoch Childrens Research Institute
Study Sponsor  ICMJE Murdoch Childrens Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP