Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000215921
Ethics application status
Approved
Date submitted
21/02/2011
Date registered
28/02/2011
Date last updated
28/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of an internet-based depression treatment program: Depression Online
Scientific title
Depression Online: An RCT evaluation of Self-Monitoring versus a Fully Automated online treatment program for people with Depression.
Secondary ID [1] 253614 0
The trial will only be registered with ANZCTR.
Universal Trial Number (UTN)
U1111-1119-5206
Trial acronym
The-DO-Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of an online intervention study on depression 261173 0
Condition category
Condition code
Mental Health 259328 259328 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will evaluate the effectiveness of Depression Online (DO) an
internet-based treatment program for consumers who experience depressive symptoms or receive a diagnosis of a depressive disorder by implementing a randomised controlled trial (RCT). Consumers of Depression Online will complete 12 CBT-based modules that provide
information and strategies for the treatment of depression. Consumers who participate in the trial will be randomly assigned to one of two conditions: (1) Fully Automated - DO (FA-DO) or (2) Self-monitoring waitlist control (SMWLC). A brief description of each condition follows.
The DO Program is an automated, self-help program that consists of 12 evidence-based modules. Each participant will be required to complete one module per week over a 12-week period. The program will provide participants with information about Depression and strategies on how to address thoughts, feelings and behaviours that contribute to or maintain Depressive Disorders. Participants who are allocated to the Self Monitoring Waiting List control are required to monitor their mood for a 12 week period before they are given access to the Depression Online program. A therapist will monitor a participant to determine whether there is any deterioration in mood that requires action. Participants who monitor their mood over a 12 week period are then invited to participate in the DO program.

A participant's involvement in the study depends on which condition they have been allocated to. For participants allocated to the Depression Online (DO) program, participation is required for a 12 week period. During this time, the DO program involves approximately 1 hour of online reading and approximately 1 hour of offline activities per week. Questionnaires at each of the time points (baseline, week 4, week 8 and week 12 ) will take approximately 30 to 60 minutes to complete. Six (6) moths after completing the DO program (follow-up), participants are invited back to complete a number of questionnaires that should take approximately 60 minutes. For participants allocated to the Self-Monitoring (Waiting List Control), they are required to monitor their mood for a 12 week period (on a weekly basis). The Self-Monitoring task should take no more than 5 minutes to complete. Once the 12 week period has lapsed, participants commence the DO program and follow the same protocol described above.
Intervention code [1] 258047 0
Treatment: Other
Comparator / control treatment
The Self Monitoring Waiting List Control (SMWLC) will commence the Fully Automated (FA-DO) intervention immediately after completing the self-monitoring task (i.e. after week 12). During the SMWLC condition, the student-researcher will be in email-contact with participants if they do not provide their ‘mood data’ for two weeks. If this occurs, the researcher will email-contact participants and prompt them to either: re-commence monitoring their mood, direct them to the ‘exit survey’ if they decide to withdraw from the study or notify their General Practitioners if participants to not respond to the student-researcher email.
Control group
Active

Outcomes
Primary outcome [1] 262152 0
Reduction in depressive symptomatology or remission of depressive disorder as measured by online psychological assessment instrument (e-PASS)
Timepoint [1] 262152 0
After randomisation has occurred: week 1 (baseline, pre-intervention) and after week 12 (post-intervention)
Primary outcome [2] 262185 0
Reduction in Centre for Epidemiological Studies-Depression (CES-D) and Depression, Anxiety, Stress Scale - 21 (DASS-21) scores on depression and distress
Timepoint [2] 262185 0
After randomisation has occurred: week 1 (baseline), month 1, month 2, month 3 (post intervention), month 6 (follow-up)
Secondary outcome [1] 273282 0
Reduction in Dysfuctional beliefs Scale (DAS) score of people experiencing depression
Timepoint [1] 273282 0
After randomisation has occurred: week 1 (baseline), month 1, month 2, month 3 (post intervention), month 6 (follow-up)

Eligibility
Key inclusion criteria
Participants are eligible to participate in the study if they experience depressive symptoms or a depressive
disorder. In this sense mental illness is strictly defined as those participants identified by the e-PASS
assment tool as experiencing depressive phenomenon. The e-PASS assessment tool will provide
participants with details as to the type and severity of their psychological symptoms or disorders and provide
appropriate recommendations for addressing their problem/s. It will also help determine whether participants
meet eligibility for the Depression Online (DO) program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if the e-PASS program finds that they do not experience depressive symptoms
(no depression diagnosis – clinical or subclinical) or they experience any of the following disorders as
primary or conditions: (a) a concurrent medical condition that is contributing to their depression (b) an
organic or psychotic problem (c) a primary substance abuse disorder (d) an eating disorder or (e) a bipolar
disorder. If consumers are unable to complete the required online depression-specific assessment measures
and/or are unable consent to the treatment protocol they will also be excluded.

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)
The student-researcher will be blind to whether participants will be allocated to either the experimental or control conditions. All participants will be randomly allocated to either condition by using a computer generated 'randomisation table'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participant randomisation will be occur by a 'computer-generated random numbers table table' held by an
independent person associated by the National e-Therapy Centre. When a new participant is recruited, the
independent person will inform the researcher what condition the participant has been allocated to.
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
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258526 0
University
Name [1] 258526 0
Swinburne University of Technology
Country [1] 258526 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 257703 0
None
Name [1] 257703 0
Address [1] 257703 0
Country [1] 257703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260493 0
Swinburne University's Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 260493 0
Ethics committee country [1] 260493 0
Australia
Date submitted for ethics approval [1] 260493 0
Approval date [1] 260493 0
10/12/2010
Ethics approval number [1] 260493 0
2010/289

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

Contacts
Principal investigator
Name 32220 0
Address 32220 0
Country 32220 0
Phone 32220 0
Fax 32220 0
Email 32220 0
Contact person for public queries
Name 15467 0
Professor Michael Kyrios
Address 15467 0
Professor Michael Kyrios
Faculty of Life and Social Sciences
Swinburne University of Technology
PO Box 218
Hawthorn VIC 3122
Country 15467 0
Australia
Phone 15467 0
+61 3 9214 4886
Fax 15467 0
Email 15467 0
mkyrios@swin.edu.au
Contact person for scientific queries
Name 6395 0
Professor Michael Kyrios
Address 6395 0
Professor Michael Kyrios
Faculty of Life and Social Sciences
Swinburne University of Technology
PO Box 218
Hawthorn VIC 3122
Country 6395 0
Australia
Phone 6395 0
+61 3 9214 4886
Fax 6395 0
Email 6395 0
mkyrios@swin.edu.au

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
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Documents added automatically
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