Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000510044
Ethics application status
Approved
Date submitted
21/06/2010
Date registered
21/06/2010
Date last updated
21/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Trial of an Internet Intervention for Depressive Symptoms: OnTrack Depression
Scientific title
A preliminary evaluation of the efficacy of an integrated internet-based treatment vs a brief internet-based treatment for depression.
Secondary ID [1] 252062 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 257600 0
Condition category
Condition code
Mental Health 257775 257775 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 modules of integrated treatment.
a) all modules are internet-based.
b) each module can be done at the client's own pace. they could be completed in one sitting (approximately an hour each) but it is recommended that the client pace themselves and complete the modules on a weekly basis.
c) the overall length of the intervention is 3 months because participants are prompted via email to check in weekly for 3 months to complete mood monitoring (online rating of best and worst mood for day which takes approximately 1 minutes to complete) while they continue to implement changes instigated by the modules.
d) general topics in the 5 modules are 1) identifying and planning for triggers and early warning signs of depression 2) mindfulness and behavioural activation 3) problem-solving and cognitive-behavioural therapy (CBT) and continuing mindfulness 4) building relationships and conflict resolution and continuing mindfulness 5) reviewing personal changes, goal setting for the future, and continuing mindfulness.
Intervention code [1] 256690 0
Treatment: Other
Comparator / control treatment
Brief intervention only: 1 module of identifying and planning for triggers and early warning signs of depression.
a) the module is internet-based.
b) the module can be done at the client's own pace, but it could be completed in one sitting (approximately an hour).
c) the overall length of the intervention is 3 months because participants are prompted via email to check in weekly for 3 months to complete mood monitoring (online rating of best and worst mood for day which takes approximately 1 minutes to complete) while they continue to implement changes instigated by the module.
Control group
Active

Outcomes
Primary outcome [1] 258646 0
Depressed mood - measured by the Depression Anxiety Stress Scale - 21 (DASS-21) and daily worst mood ratings.
Timepoint [1] 258646 0
baseline and at 3 months following randomisation
Secondary outcome [1] 264619 0
Whether depression outcomes from internet treatment are moderated by treatment expectancy (measured on a scale of 1-100), number of modules accessed or tools completed, or use of mindfulness.
Timepoint [1] 264619 0
Treatment expectancy at baseline.
Module access and completion at 3 months.
Secondary outcome [2] 264620 0
Whether depression outcomes from internet treatment are predicted by previous major depressive episodes (e.g. 0, 1-2, 3 or more), or quality of life (measured by World Health Organization Quality of Life - Brief Form [WHOQOL-BREF]).
Timepoint [2] 264620 0
Baseline

Eligibility
Key inclusion criteria
1) Meet Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for a lifetime major depressive episode and/or score at least 14 on the Depression scale of the Depression Anxiety Stress Scale (e.g., 'moderate' depression)
4) sufficient english to complete treatments and assessments without translation
5) able and willing to access internet/email/text messages
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) reported weekly alcohol consumption in the last month of more than 14 units/week for 2 weeks for females and more than 28 units/week for 2 weeks for males 2) use of injectable drugs in the previous month 3) daily use of an illicit substance 4) history of psychosis lasting more than 2 days 5) diagnosis of bipolar disorder 6) acutely suicidal 7) self harm requiring medical treatment in last 12 months

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 view www.ontrack.org.au in response to a referral or advertising and will register to receive a screening call. During the call they are given information about the research. If they are interested in participating the screening information sheet is read over the phone and the participant provides verbal consent for screening. If they meet screening eligibility requirements they are sent an email link that takes them to the consent form and online assessment questionnaires. Following this they receive a baseline assessment phone call and complete 7 days of daily worst mood ratings. Once all baseline assessments are completed they are randomly allocated to one of 2 treatment groups and provided with a username and password to access the online program. The person conducting the baseline assessments will have no way of knowing which treatment group the client will be allocated to as it is randomly generated by the computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation - computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/05/2010
Actual
26/05/2010
Date of last participant enrolment
Anticipated
Actual
14/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257158 0
University
Name [1] 257158 0
School of Psychology & Counselling, Queensland University of Technology
Country [1] 257158 0
Australia
Primary sponsor type
University
Name
Institute of Health and Biomedical Innovation, Queensland University of Technology
Address
60 Musk Ave, Kelvin Grove, QLD, 4059
Country
Australia
Secondary sponsor category [1] 256415 0
Individual
Name [1] 256415 0
Professor David Kavanagh
Address [1] 256415 0
Institute of Health and Biomedical Innovation,
60 Musk Ave,
Kelvin Grove, QLD, 4059
Country [1] 256415 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259201 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 259201 0
Research Ethics Unit
Level 4,
88 Musk Avenue,
Kelvin Grove QLD 4059
Ethics committee country [1] 259201 0
Australia
Date submitted for ethics approval [1] 259201 0
Approval date [1] 259201 0
31/03/2010
Ethics approval number [1] 259201 0
1000000040

Summary
Brief summary
The current study is a randomised controlled trial aiming to test the preliminary efficacy of an internet-based intervention for people with depressive symptoms. There will be 2 groups of randomly allocated participants who will be followed up after 3 months of an online program: 1. Brief Intervention Group – will be an active control condition providing a minimum, ethically feasible treatment including Psychoeducation on depression, a Personal Diary for recording mood, and tools for detecting and planning for triggers and early warning signs of depression. 2. 5 Module Treatment Group – will include the components of the Brief Intervention Group as well as specific modules involving Mindfulness Meditation, Social support/relationships, Problem Solving and CBT strategies, Pleasant Activity Scheduling, and reviewing personal changes and making future goals. Primary predictions are that the 5 Module Treatment group will have superior depression outcomes at 3 months compared to the Brief Intervention group.
Trial website
www.ontrack.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31307 0
Prof David Kavanagh
Address 31307 0
Institute of Health and Biomedical Innovation 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 31307 0
Australia
Phone 31307 0
+61 7 31386143
Fax 31307 0
Email 31307 0
[email protected]
Contact person for public queries
Name 14554 0
Prof David Kavanagh
Address 14554 0
Institute of Health and Biomedical Innovation
60 Musk Ave,
Kelvin Grove, QLD, 4059
Country 14554 0
Australia
Phone 14554 0
+61 7 31386143
Fax 14554 0
Email 14554 0
[email protected]
Contact person for scientific queries
Name 5482 0
Prof David Kavanagh
Address 5482 0
Institute of Health and Biomedical Innovation
60 Musk Ave,
Kelvin Grove, QLD, 4059
Country 5482 0
Australia
Phone 5482 0
+61 7 31386143
Fax 5482 0
Email 5482 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

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