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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00794222




Registration number
NCT00794222
Ethics application status
Date submitted
19/11/2008
Date registered
20/11/2008
Date last updated
20/11/2008

Titles & IDs
Public title
A Mobile Phone Self-Monitoring Tool to Increase Emotional Self-Awareness and Reduce Depression in Young People
Scientific 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.
Secondary ID [1] 0 0
Telstra Foundation: N33E2912
Secondary ID [2] 0 0
RCH28113
Universal Trial Number (UTN)
Trial acronym
mobiletype
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Mobile Tracking Young People's Experiences (mobiletype)

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.

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.


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depressive symptoms
Timepoint [1] 0 0
Pre-, post-monitoring, 6-week follow up & 6 month follow-up
Secondary outcome [1] 0 0
Emotional Self-awareness
Timepoint [1] 0 0
Pre-, post-monitoring, 6 week and 6 month follow up
Secondary outcome [2] 0 0
Detection of mental health problems
Timepoint [2] 0 0
Pre-, post-monitoring, 6 week and 6 month follow up
Secondary outcome [3] 0 0
Pathways to care
Timepoint [3] 0 0
Pre-, post-monitoring, 6 week and 6 month follow up
Secondary outcome [4] 0 0
Patient's satisfaction with their GP
Timepoint [4] 0 0
Pre-, post-monitoring, 6 week and 6 month follow up

Eligibility
Key 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
Minimum age
14 Years
Maximum age
24 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Clifton Hill Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3068 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00794222
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sylvia D Kauer, BBSci(Hons)
Address 0 0
Murdoch Childrens Research Instititue
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sophie Reid, PhD,MPsych
Address 0 0
Country 0 0
Phone 0 0
0393457913
Fax 0 0
Email 0 0
Sophie.reid@mcri.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00794222