Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000625077
Ethics application status
Approved
Date submitted
29/07/2010
Date registered
30/07/2010
Date last updated
15/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of electronic program to help people self-monitor and self-manage of mild to moderate mental health problems
Scientific title
Randomised Controlled Trial to evaluate the effect on mental health of a self-monitoring and self-management program delivered by mobile phone and computer for people with mild to moderate depression, anxiety or stress compared against an attention control program, and a waitlist control.
Secondary ID [1] 252345 0
Nil
Universal Trial Number (UTN)
U1111-1116-3261
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 257848 0
Anxiety 257849 0
Stress 257850 0
Condition category
Condition code
Mental Health 258015 258015 0 0
Depression
Mental Health 258016 258016 0 0
Anxiety
Public Health 258017 258017 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receiving the intervention will use an electronic self-monitoring and self-management program for 6 weeks, accessed via their mobile phone and computer. The program consists of real time monitoring of symptoms with sms prompts, therapeutic modules, fact sheets, tips, motivational messages and a journal.
Intervention code [1] 256902 0
Treatment: Devices
Intervention code [2] 256903 0
Behaviour
Intervention code [3] 256904 0
Other interventions
Comparator / control treatment
There are two control groups.

(1.) An online attention control providing minimal information about depression, anxiety and stress, together with weekly motivational messages for 6 weeks.

(2.) A waitlist control, who will receive the full electronic self-monitoring and self-management program immediately after the intervention group concludes their treatment (6 weeks after the start of the program).
Control group
Active

Outcomes
Primary outcome [1] 258871 0
Mean Depression Anxiety Stress Scales (DASS) score
Timepoint [1] 258871 0
At baseline, and at 3, 6, 9, 12, 15 and 18 weeks after intervention commencement
Secondary outcome [1] 264997 0
Subjective Units of Distress Scales (SUDS)
Timepoint [1] 264997 0
At baseline, and at 3, 6, 9, 12, 15 and 18 weeks after intervention commencement
Secondary outcome [2] 264998 0
Work & Social Adjustment Scale
Timepoint [2] 264998 0
At baseline, and at 6 and 18 weeks after intervention commencement
Secondary outcome [3] 264999 0
Utilisation of Health Services. This will be assessed using a questionnaire asking for details about participants use of varying health services and medications.
Timepoint [3] 264999 0
At baseline, and at 3, 6, 9, 12, 15 and 18 weeks after intervention commencement
Secondary outcome [4] 265000 0
Self efficacy for coping with Depression, Anxiety and Stress. This will be assessed using our new six-item questionnaire developed using Bandura's (2006) guidelines.
Timepoint [4] 265000 0
At baseline, and at 6 and 18 weeks after intervention commencement

Eligibility
Key inclusion criteria
Participants must:

1.) have a current episode of mild to moderate depression, anxiety or stress
2.) own a mobile phone and have access to a computer and the internet
3.) have a current, valid email address
4.) live in Australia
5.) be able to read and write English
6.) agree to use the program for 6 weeks and to complete questionnaires on 3 occasions
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.) severe anxiety, stress or depression
2.) suicidal ideation
3.) psychosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via the Black Dog Insititute clinic and website, as well as through advertisements disseminated through community groups and large organisations (e.g. National Australia Bank, Commonwealth Bank of Australia and Telstra). Participants will provide informed consent and will be enrolled electronically into the study, under the supervision of the study’s research officer. The random allocation of participants into conditions will be carried out electronically, under the supervision of a research officer not associated with the study. Chief Investigators and research officers associated with the study will have no knowledge in advance of the treatments to which participants will be assigned. Thus, allocation will be concealed using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a computerised random sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257360 0
Government body
Name [1] 257360 0
Australian Government; Department of Health and Aging
Country [1] 257360 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Judy Proudfoot
Address
Black Dog Institute and School of Psychiatry
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 256601 0
Individual
Name [1] 256601 0
Professor Gordon Parker
Address [1] 256601 0
Black Dog Institute and School of Psychiatry
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country [1] 256601 0
Australia
Secondary sponsor category [2] 256602 0
Individual
Name [2] 256602 0
Associate Professor Vijaya Manicavasagar
Address [2] 256602 0
Black Dog Institute and School of Psychiatry
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country [2] 256602 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259379 0
Universities of New South Wales Human Research Ethics Committee
Ethics committee address [1] 259379 0
Ethics committee country [1] 259379 0
Australia
Date submitted for ethics approval [1] 259379 0
Approval date [1] 259379 0
23/03/2010
Ethics approval number [1] 259379 0
HREC 10019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31450 0
Address 31450 0
Country 31450 0
Phone 31450 0
Fax 31450 0
Email 31450 0
Contact person for public queries
Name 14697 0
Dr Virginia Harrison
Address 14697 0
The Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country 14697 0
Australia
Phone 14697 0
+61 2 9382 3719
Fax 14697 0
Email 14697 0
[email protected]
Contact person for scientific queries
Name 5625 0
Associate Professor Judy Proudfoot
Address 5625 0
The Black Dog Institute and School of Psychiatry
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country 5625 0
Australia
Phone 5625 0
+61 2 9382 3767
Fax 5625 0
Email 5625 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of a mobile phone and web program on symptom and functional outcomes for people with mild-to-moderate depression, anxiety and stress: A randomised controlled trial.2013https://dx.doi.org/10.1186/1471-244X-13-312
N.B. These documents automatically identified may not have been verified by the study sponsor.