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Trial registered on ANZCTR


Registration number
ACTRN12612000433808
Ethics application status
Approved
Date submitted
16/04/2012
Date registered
17/04/2012
Date last updated
7/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Is internet-delivered treatment specifically for symptoms of generalised anxiety disorder as effective as internet-delivered treatment for symptoms of both anxiety and depression, and are self-guided versions of these as effective as therapist-guided versions?
Scientific title
A randomized controlled trial of the effects of disorder-specific vs. trans-diagnostic and self-guided vs. guided Internet-administered treatment on symptoms of generalised anxiety disorder in Australian adults.
Secondary ID [1] 280339 0
Nil
Universal Trial Number (UTN)
Trial acronym
WELLRCT4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised anxiety disorder 286299 0
Condition category
Condition code
Mental Health 286544 286544 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this trial Australian adults with symptoms of generalised anxiety disorder will be randomly allocated to one of four groups. Two of the four groups will receive access to an 8 week internet-delivered treatment course specifically for generalised anxiety disorder (disorder-specific treatment course). The other two groups will receive access to an 8 week internet-delivered treatment course for symptoms of anxiety and depression (trans-diagnostic treatment course).

Over the 8 weeks, all participants will be directed to read 5 online lessons about management of symptoms. One lesson will be completed every 7 to 14 days. Each lesson will take about 15 minutes to read. Participants will also have access to summaries and homework assignments for each lesson, and will read stories about people with similar symptoms, taking a further 20 minutes per week.

The four groups are:
Group 1: Self-guided - disorder-specific course. Participants in this group will complete the disorder-specific generalised anxiety disorder treatment course in a self-guided format, that is, without support from a therapist.
Group 2: Self-guided - trans-diagnostic. Participants in this group will complete the trans-diagnostic treatment course in a self-guided format, that is, without support from a therapist.
Group 3: Guided - disorder-specific. Participants in this group will complete the disorder-specific generalised anxiety disorder treatment course in a guided format, that is, with weekly telephone or email support from a therapist.
Group 4: Guided - trans-diagnostic. Participants in this group will complete the trans-diagnostic treatment course in a guided format, that is, with weekly telephone or email support from a therapist.

Participants in all groups will also receive twice weekly automatic emails providing reminders about the course and encouragement to continue.

Study questionnaires will be administered at pre-treatment, post-treatment, and at 6, 12, and 24 months post-treatment. These will take about 20-30 minutes to complete. Participants will also complete brief measures of mood and anxiety before each lesson. The treatment materials include cognitive behavioural treatment (CBT) skills.
Intervention code [1] 284696 0
Treatment: Other
Intervention code [2] 284697 0
Behaviour
Comparator / control treatment
This 2 (self-guided vs. guided) X 2 (trans-diagnostic vs. disorder-specific) RCT does not have a formal control group, as it compares active treatments. However, data from historical controls will be obtained and compared from similar studies conducted by this research team over the period 2007-2012. These studies include:

Dear, B. F., Titov, N., Schwencke, G., Andrews, G., Johnston, L., Craske, M. G., & McEvoy, P. (2011). An open trial of a brief transdiagnostic treatment for anxiety and depression. Behaviour Research and Therapy, 49, 830-837.

Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske M, McEvoy P. (2011). Transdiagnostic Internet treatment of anxiety and depression: A randomised controlled trial. Behaviour Research and Therapy, 49; 441-452.

Titov N, Andrews G, Schwencke G, Robinson E, Peters L, Spence J. (2010). An RCT of Internet CBT for social phobia with and without motivational enhancement strategies. Australian and New Zealand Journal of Psychiatry;44:938-945.

Wims E, Titov N, Andrews G, Choi I. (2010). Clinician-assisted Internet-based treatment is effective for panic: A randomized controlled trial. Australian and New Zealand Journal of Psychiatry;44:599-607.

Titov N, Andrews G, Johnston L, Robinson E, Spence J. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial, Behaviour Research and Therapy (2010), 48:890-899. doi:10.1016/j.brat.2010.05.014

Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K. (2010). Internet treatment for depression: A randomized controlled trial comparing clinician vs. technician assistance. PLoS ONE 5(6): e10939. doi:10.1371/journal.pone.0010939.

Robinson E, Titov N, Andrews G, McIntyre K, Schwencke G, Solley K. (2010). Internet treatment for generalized anxiety disorder: A randomized controlled trial comparing clinician vs. technician assistance. PLoS ONE, 5(6): e10942. doi:10.1371/journal.pone.0010942.

Titov N, Andrews G, Choi I, Schwencke G, Johnston L. (2009). Randomized controlled trial of web-based treatment of social phobia without clinical guidance. Australian and New Zealand Journal of Psychiatry;43:913-919.

Titov N, Andrews G, Johnston J, Schwencke G, Choi I. (2009). The Shyness program: Longer term benefits, cost-effectiveness, and acceptability. Australian and New Zealand Journal of Psychiatry;43:36-44.

Titov N, Andrews G, Robinson E, Schwencke G, Johnston L, Solley K, Choi I. (2009). Clinician-assisted Internet-based treatment is effective for generalized anxiety disorder: A randomized controlled trial. Australian and New Zealand Journal of Psychiatry;43:905-912.

Titov N, Andrews G, Schwencke G, Solley K, Johnston L, Robinson E. (2009). An RCT comparing two types of support on severity of symptoms for people completing Internet-based cognitive behavior therapy for social phobia. Australian and New Zealand Journal of Psychiatry;43:920-926.
Control group
Historical

Outcomes
Primary outcome [1] 286974 0
Symptoms and severity of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [1] 286974 0
Administered at pre-treatment, prior to each Lesson in the course, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [1] 297075 0
Symptoms and severity of low mood/depression are measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 297075 0
Administered at pre-treatment, prior to each Lesson in the course, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [2] 297076 0
Health status is measured by the European Quality of Life-5 Dimensions- 5 Level (EQ-5D-5L)
Timepoint [2] 297076 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [3] 297077 0
Psychological distress is measured with the Kessler-10 item (K-10)
Timepoint [3] 297077 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [4] 297078 0
Disability is measured by the Sheehan Disability Scales (SDS)
Timepoint [4] 297078 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [5] 297079 0
Positive adaptive behaviours are measured by the Things You Do Questionnaire (TYD)
Timepoint [5] 297079 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [6] 297080 0
Working alliance is measured by the Working Alliance Inventory (WAI)
Timepoint [6] 297080 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [7] 297081 0
Health service use will be measured by the Service Use Questionnaire
Timepoint [7] 297081 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [8] 297082 0
Symptoms and severity of social anxiety are measured by the MINI-Social Phobia Inventory (MINI-SPIN)
Timepoint [8] 297082 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment
Secondary outcome [9] 297084 0
Symptoms and severity of panic disorder are measured by the Panic Disorder Severity Rating Scale - Self Report (PDSS-SR)
Timepoint [9] 297084 0
Administered at pre-treatment, at post-treatment, and at 6, 12, and 24 months post-treatment

Eligibility
Key inclusion criteria
1. Self-identifying as having difficulties with symptoms of generalised anxiety disorder.
2. Elevated symptoms of generalised anxiety disorder as indicated by a score of 5 or more on the GAD-7, indicating at least mild symptoms.
3. No current participation in cognitive behavioural treatment for generalised anxiety disorder.
4. No change in medications in the period 1 month prior to this 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 at application (score of 23 or greater on PHQ-9)
2. Suicidal intent or plan at application (either reporting suicidal intent or responding >2 to Question 9 [suicidal ideation] on the PHQ-9)
3. Scoring below cut-offs on PHQ-9
4. Current psychosis
5. Principal presenting problem not symptoms of generalised anxiety disorder

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 apply online, and those who meet inclusion criteria are randomly allocated to one of the four groups. Allocation concealment will not be required, as applications are date stamped, and allocation is automatically assigned. The validity of this process will be checked daily by the CI.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a permuted block sequence using a list generated prior to the study via a software program (www.randomizer.org). The list will then be transcribed into an electronic format and merged with the online application system, such that eligible applicants are automatically assigned the next number in the sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2012
Actual
19/04/2012
Date of last participant enrolment
Anticipated
Actual
26/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
208
Accrual to date
Final
338
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285113 0
Government body
Name [1] 285113 0
National Health and Medical Research Council
Country [1] 285113 0
Australia
Primary sponsor type
University
Name
Centre for Emotional Health, Department of Psychology, Macquarie University
Address
Building/Room C3A 724
Macquarie University
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 283970 0
None
Name [1] 283970 0
Address [1] 283970 0
Country [1] 283970 0
Other collaborator category [1] 260743 0
Individual
Name [1] 260743 0
Dr Peter McEvoy
Address [1] 260743 0
Centre for Clinical Interventions (CCI) 223 James St Northbridge Western Australia 6003
Country [1] 260743 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287125 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 287125 0
Macquarie University
North Ryde
NSW 2109
Ethics committee country [1] 287125 0
Australia
Date submitted for ethics approval [1] 287125 0
Approval date [1] 287125 0
12/10/2011
Ethics approval number [1] 287125 0
5201100680 (Macquarie University HREC Reference Number)

Summary
Brief summary
This project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the relative efficacy of a disorder-specific internet-delivered treatment for generalised anxiety disorder vs. trans-diagnostic internet-delivered treatment for both anxiety and depression. Both interventions will be tested in guided and self-guided formats.

We expect that the guided interventions will result in superior outcomes to the unguided interventions. We do not expect differences between the two guided interventions at post-treatment, but expect that the trans-diagnostic treatment will result in superior outcomes at follow-ups.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Dear, B. F., Staples, L., Terides, M. D., Karin, E., Zou, J., Johnston, L., Gandy, M., Fogliati, V. J., Wootton, B. M., McEvoy, P. M., & Titov, N. (2015). Transdiagnostic versus disorder-specific and clinician-guided versus self-guided internet-delivered treatment for generalized anxiety disorder and comorbid disorders: A randomized controlled trial. Journal of Anxiety Disorders, 36, 63-77.
Public notes

Contacts
Principal investigator
Name 34075 0
Prof Nick Titov
Address 34075 0
Centre for Emotional Health, Department of Psychology, Building/Room C3A 724 Macquarie University North Ryde NSW 2109
Country 34075 0
Australia
Phone 34075 0
+61 2 98509901
Fax 34075 0
Email 34075 0
nick.titov@mq.edu.au
Contact person for public queries
Name 17322 0
Prof Nick Titov
Address 17322 0
Centre for Emotional Health, Department of Psychology,
Building/Room C3A 724
Macquarie University
North Ryde
NSW 2109
Country 17322 0
Australia
Phone 17322 0
+61 2 9850 9901
Fax 17322 0
+61 2 9850 8062
Email 17322 0
nick.titov@mq.edu.au
Contact person for scientific queries
Name 8250 0
Prof Nick Titov
Address 8250 0
Centre for Emotional Health, Department of Psychology,
Building/Room C3A 724
Macquarie University
North Ryde
NSW 2109
Country 8250 0
Australia
Phone 8250 0
+61 2 9850 9901
Fax 8250 0
+61 2 9850 8062
Email 8250 0
nick.titov@mq.edu.au

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