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Trial registered on ANZCTR


Registration number
ACTRN12613000915752
Ethics application status
Approved
Date submitted
13/08/2013
Date registered
16/08/2013
Date last updated
8/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the efficacy of therapist-guided and self-guided internet-delivered treatment for young adults (18-24) with symptoms of anxiety and depression?
Scientific title
A randomized controlled trial of the effects of self-guided vs. guided Internet-administered treatment on symptoms of anxiety and depression in Australian young adults (18-24).
Secondary ID [1] 283012 0
Nil
Universal Trial Number (UTN)
Trial acronym
MMRCT1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 289838 0
Depression 289839 0
Condition category
Condition code
Mental Health 290194 290194 0 0
Anxiety
Mental Health 290195 290195 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this trial Australian young adults (18-24) with symptoms of anxiety and depression will be randomly allocated to one of two groups.

The two groups are:
Group 1: Self-guided - treatment. Participants in this group will complete the treatment in a self-guided format, that is, without support from a therapist.
Group 2: Guided - treatment. Participants in this group will complete the treatment in a guided format, that is, with weekly telephone or email support from a therapist.

Over the 5 weeks, all participants will be directed to read 4 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.

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

Study questionnaires will be administered at pre-treatment, post-treatment, and at 3 and 12 post-treatment. These will take about 10-15 minutes to complete. Participants will also complete brief measures of mood, anxiety and adaptive coping techniques before each lesson. The treatment materials include cognitive behavioural treatment (CBT) skills.
Intervention code [1] 287727 0
Treatment: Other
Intervention code [2] 287744 0
Behaviour
Comparator / control treatment
This 2 group (self-guided vs. guided) 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:

Titov, N., Dear, B.F., Johnston, L., Lorian, C., Zou, J., Wootton, B., Spence, J., McEvoy, P., Rapee, R.M. (In Press). Improving adherence and clinical outcomes in self-guided internet treatment for anxiety and depression: randomised controlled trial. PLoS ONE.

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.

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, 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] 290220 0
Symptoms and severity of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [1] 290220 0
Administered at pre-treatment, prior to each Lesson in the course, at post-treatment, and at 3 and 12 months post-treatment
Primary outcome [2] 290221 0
Symptoms and severity of low mood/depression are measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 290221 0
Administered at pre-treatment, prior to each Lesson in the course, at post-treatment, and at 3 and 12 months post-treatment
Secondary outcome [1] 304144 0
Disability is measured by the Sheehan Disability Scales (SDS)
Timepoint [1] 304144 0
Administered at pre-treatment, at post-treatment, and at 3 and 12 months post-treatment
Secondary outcome [2] 304145 0
Life satisfaction is measured by the Satisfaction with Life Scale (SWLS)
Timepoint [2] 304145 0
Administered at pre-treatment, at post-treatment, and at 3 and 12 months post-treatment
Secondary outcome [3] 304146 0
Psychological distress is measured with the Kessler-10 item (K-10)
Timepoint [3] 304146 0
Administered at pre-treatment, at post-treatment, and at 3 and 12 months post-treatment
Secondary outcome [4] 304147 0
Positive adaptive behaviours are measured by the Things You Do Questionnaire (TYDQ)
Timepoint [4] 304147 0
Administered at pre-treatment, prior to each Lesson in the course, at post-treatment, and at 3 and 12 months post-treatment

Eligibility
Key inclusion criteria
1. Resident of Australia.
2. Aged between 18 to 24 years years old.
3. No current participation in cognitive behavioural treatment for anxiety or depression.
4. Provides informed consent.
5. Reliable access to the Internet.
Minimum age
18 Years
Maximum age
24 Years
Gender
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. Principal presenting problem not symptoms of anxiety or depression

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 two 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
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287776 0
Charities/Societies/Foundations
Name [1] 287776 0
beyondblue: the national depression initiative
Address [1] 287776 0
PO Box 6100
Hawthorn West
Victoria 3122
Country [1] 287776 0
Australia
Primary sponsor type
University
Name
eCentreClinic, Centre for Emotional Health, Department of Psychology, Macquarie University
Address
C3A 724
Macquarie University
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 286503 0
None
Name [1] 286503 0
Address [1] 286503 0
Country [1] 286503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289726 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 289726 0
Macquarie University
North Ryde
NSW 2109
Ethics committee country [1] 289726 0
Australia
Date submitted for ethics approval [1] 289726 0
Approval date [1] 289726 0
08/08/2013
Ethics approval number [1] 289726 0
5201300456

Summary
Brief summary
This project is part of a research program funded by beyondblue to develop and evaluate Internet based treatment programs for young adults (18-24) with anxiety and depression. This project examines the relative efficacy of guided and self-guided internet delivered treatment.

We expect that the guided interventions will result in superior outcomes to the unguided interventions.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
1. Johnston L, Titov N, Andrews G.Spence J, Dear BF. (2011). A randomized controlled trial of a transdiagnostic Internet-delivered treatment for anxiety disorders. PLoS ONE, 6(11): e28079. doi:10.1371/journal.pone.0028079.

2. 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.

3. 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.
Public notes

Contacts
Principal investigator
Name 42126 0
A/Prof Nickolai Titov
Address 42126 0
Centre for Emotional Health, Department of Psychology, Building/Room C3A 724 Macquarie University North Ryde NSW 2109
Country 42126 0
Australia
Phone 42126 0
+61 2 9850 9901
Fax 42126 0
+61 2 9850 8062
Email 42126 0
nick.titov@mq.edu.au
Contact person for public queries
Name 42127 0
A/Prof Nickolai Titov
Address 42127 0
Centre for Emotional Health, Department of Psychology, Building/Room C3A 724 Macquarie University North Ryde NSW 2109
Country 42127 0
Australia
Phone 42127 0
+61 2 9850 9901
Fax 42127 0
+61 2 9850 8062
Email 42127 0
nick.titov@mq.edu.au
Contact person for scientific queries
Name 42128 0
A/Prof Nickolai Titov
Address 42128 0
Centre for Emotional Health, Department of Psychology, Building/Room C3A 724 Macquarie University North Ryde NSW 2109
Country 42128 0
Australia
Phone 42128 0
+61 2 9850 9901
Fax 42128 0
+61 2 9850 8062
Email 42128 0
nick.titov@mq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary