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Trial registered on ANZCTR


Registration number
ACTRN12610001058066
Ethics application status
Approved
Date submitted
25/11/2010
Date registered
2/12/2010
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of the effects of different levels of graded support on symptoms of anxiety and depression in adults using the Internet-based Wellbeing Course
Scientific title
Randomized controlled trial of the effects of two levels of graded support on symptoms of anxiety and depression using an Internet-based education program for anxiety and depression
Secondary ID [1] 253171 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder (a depressive disorder) 258711 0
Generalised anxiety disorder (an anxiety disorder) 258712 0
Panic disorder (with or without agoraphobia) (both anxiety disorders) 258713 0
Social phobia (an anxiety disorder) 258714 0
Condition category
Condition code
Mental Health 258868 258868 0 0
Depression
Mental Health 258869 258869 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of three groups: Group 1: Waitlist Control (who will begin the program 9 weeks after the other Groups). This group will receive the same intervention as Group 3. Group 2: Self-Guided Group. This group will receive access to all the program materials including access to the 5 online lessons and homework assignments, to stories written by previous participants with symptoms of anxiety and depression, and access to additional written resources. Group 3: Self-Guided + Automatic Email Group. This group will receive access to all the materials provided to Group 2, but will also receive regular automatic emails to inform participants about new materials, upcoming lessons, and reminders to complete lessons.

All participants will receive online access to 5 lessons of Internet based education about management of symptoms of depression and anxiety. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to homework assignments/summaries of each lesson, and will read anonymous stories about other people with anxiety and depression, taking a further 10 minutes per week. The duration of the program is 8 weeks. Participants in Groups 2 and 3 will be contacted 3 months and 12 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-education, post-education, 3-months post-education and 12 months post-education. These will take about 20-30 minutes to complete. The education materials are based on evidence-based cognitive behavioural techniques for managing symptoms of anxiety and depression.
Intervention code [1] 257666 0
Treatment: Other
Comparator / control treatment
Group 1: Waitlist Control Group. This Group will not receive access to the education program until nine weeks after the other Groups have begun.
Control group
Active

Outcomes
Primary outcome [1] 259726 0
Symptoms of depression and anxiety are measured by the Depression and Anxiety Stress Scales 21 item (DASS-21)
Timepoint [1] 259726 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Primary outcome [2] 259727 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 259727 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Primary outcome [3] 259728 0
Symptoms and severity of anxiety are by the Generalized Anxiety Disorder-7 Item (GAD-7)
Timepoint [3] 259728 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Secondary outcome [1] 266454 0
Symptoms and severity of generalized anxiety disorder are measured by the Penn State Worry Questionnaire (PSWQ)
Timepoint [1] 266454 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Secondary outcome [2] 266455 0
Symptoms and severity of panic disorder are measured by the Autonomic Nervous System Questionnaire (ANSQ)
Timepoint [2] 266455 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Secondary outcome [3] 266456 0
Symptoms and severity of social phobia are measured by the MINI-Social Phobia Inventory (MINI-SPIN)
Timepoint [3] 266456 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Secondary outcome [4] 266459 0
Symptoms and severity of disability are measured by the Sheehan Disability Scales (SDS)
Timepoint [4] 266459 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Secondary outcome [5] 266460 0
Neuroticism is measured by the NEO-Five Factor Inventory Neuroticism Scale (NEO-FFI-N)
Timepoint [5] 266460 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Secondary outcome [6] 279298 0
Health status will be measured by the EQ-5D.
Timepoint [6] 279298 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education
Secondary outcome [7] 279299 0
Health service use will be measured by the Service Use Questionnaire
Timepoint [7] 279299 0
Administered at pre-education, post-education, at 3-months post-education, and at 12-months post-education

Eligibility
Key inclusion criteria
1. Elevated symptoms of depression or anxiety as indicated by: Total scores on at least one of the following measures: PHQ-9 > 9; GAD-7 > 7; Mini SPIN > 5; ANSQ > 1. Scores above these cut-offs indicate likelihood of meeting diagnostic criteria for at least one of: depression, generalized anxiety disorder, social phobia, panic disorder, respectively.
2. Self-identifying as having difficulties with either depression, social phobia, panic disorder, or generalized anxiety disorder. Note that meeting diagnostic criteria for a formal anxiety disorder or depression is NOT an inclusion criteria – instead, participants need to have elevated symptoms of anxiety or depression as indicated in (1), above.
3. No current participation in cognitive behavioural treatment.
4. No change in medications in the period 1 month prior to this study, and no change in medications during the study.
5. Access to the Internet and a printer.
6. 18 years to 64 years old.
7. Resident of Australia.
8. Prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner
9. Prepared to provide written informed consent.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe depression (score of 23 or greater on PHQ-9)
2. Suicidal intent or plan (either reporting suicidal intent or responding >2 to Question 9 [suicidal ideation] on the PHQ-9)
3. Scoring below cut-offs on the measures of anxiety and depression
4. Current substance abuse
5. Psychosis
6. Primary presenting problem not depression, generalized anxiety disorder, social phobia, or panic disorder.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online, and those who meet inclusion criteria are randomly allocated to one of the three groups. Allocation concealment will occur by providing allocation details for each successive participant in a sealed envelope, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org), at another site, in another country. The list will then be transcribed and details transferred to sealed envelopes.
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
Completed
Date of first participant enrolment
Anticipated
20/07/2011
Actual
20/07/2011
Date of last participant enrolment
Anticipated
Actual
1/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
253
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258143 0
Government body
Name [1] 258143 0
National Health and Medical Research Council (NHMRC)
Country [1] 258143 0
Australia
Primary sponsor type
University
Name
Centre for Emotional Health, Department of Psychology, Macquarie University
Address
Building/Room C3B 518
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 257310 0
None
Name [1] 257310 0
Address [1] 257310 0
Country [1] 257310 0
Other collaborator category [1] 251686 0
Individual
Name [1] 251686 0
Dr Peter McEvoy
Address [1] 251686 0
Centre for Clinical Interventions (CCI) 223 James St Northbridge Western Australia 6003
Country [1] 251686 0
Australia
Other collaborator category [2] 251687 0
Individual
Name [2] 251687 0
Professor Michelle Craske
Address [2] 251687 0
Department of Psychology, University of California at Los Angeles (UCLA) 405 Hilgard Ave., Los Angeles, CA 90095-1563
Country [2] 251687 0
United States of America
Other collaborator category [3] 252128 0
Individual
Name [3] 252128 0
Professor Simon Gilbody, Dr Dean McMillan, Dr Shehzad Ali
Address [3] 252128 0
Mental Health Research Group, Department of Health Science, Alcuin C Block, University of York, Heslington, YO10 5DD
Country [3] 252128 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260121 0
University of New South Wales HREC A
Ethics committee address [1] 260121 0
Ethics committee country [1] 260121 0
Australia
Date submitted for ethics approval [1] 260121 0
05/10/2010
Approval date [1] 260121 0
Ethics approval number [1] 260121 0
Ethics committee name [2] 269474 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 269474 0
Ethics committee country [2] 269474 0
Australia
Date submitted for ethics approval [2] 269474 0
Approval date [2] 269474 0
08/04/2011
Ethics approval number [2] 269474 0
5201100226 (Macquarie University HREC Reference Number)

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

Contacts
Principal investigator
Name 31954 0
Prof Nick Titov
Address 31954 0
Department of Psychology
Macquarie University
NSW 2109
Country 31954 0
Australia
Phone 31954 0
61 2 9850 9979
Fax 31954 0
Email 31954 0
nick.titov@mq.edu.au
Contact person for public queries
Name 15201 0
Associate Professor Nickolai Titov
Address 15201 0
Centre for Emotional Health, Department of Psychology,
Building/Room C3B 518
Macquarie University
NSW 2109
Country 15201 0
Australia
Phone 15201 0
+61 2 9850 9901
Fax 15201 0
+61 2 9850 8062
Email 15201 0
nick.titov@mq.edu.au
Contact person for scientific queries
Name 6129 0
Associate Professor Nickolai Titov
Address 6129 0
Centre for Emotional Health, Department of Psychology,
Building/Room C3B 518
Macquarie University
NSW 2109
Country 6129 0
Australia
Phone 6129 0
+61 2 9850 9901
Fax 6129 0
+61 2 9850 8062
Email 6129 0
nick.titov@mq.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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