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Trial registered on ANZCTR


Registration number
ACTRN12613000958785
Ethics application status
Approved
Date submitted
27/08/2013
Date registered
29/08/2013
Date last updated
4/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the efficacy of therapist-guided internet-treatment, self-guided internet-treatment with pre-treatment contact, and purely self-guided internet-delivered for older adults (60+) with symptoms of anxiety and depression?
Scientific title
A randomized controlled trial of the effects of guided internet-treatment vs. self-guided internet-treatment with pre-treatment contact vs. purely self-guided internet-delivered treatment on symptoms of anxiety and depression in Australian older adults (60+).
Secondary ID [1] 283051 0
Nil
Universal Trial Number (UTN)
Trial acronym
WBPRCT3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 289888 0
Depression
 289889 0
Condition category
Condition code
Mental Health 290254 290254 0 0
Depression
Mental Health 290255 290255 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this trial Australian older adults (60+) with symptoms of anxiety and depression will be randomly allocated to one of three groups.

The three groups are:
Group 1: Purely self-guided - treatment. Participants in this group will complete the treatment in a purely self-guided format, that is, without pre-treatment contact or weekly support from a therapist.
Group 2: Self-guided with pre-treatment contact. Participants in this group will complete the treatment in a self-guided format, that is, with pre-treatment contact but no weekly support from a therapist.
Group 3: Guided - treatment. Participants in this group will complete the treatment in a guided format, that is, with pre-treatment contact as well as weekly telephone or email support from a therapist.

Pre-treatment contact will occur via a brief 5 - 10 minute telephone call with one of the two clinicians running the Course. The pre-treatment contact will involve a brief discussion about the Course requirements, orienting the participant to the Course structure and online treatment.

Weekly contact will be conducted via a brief 5 - 10 minute telephone call by one of two clinicians running the treatment groups. The weekly contact will involve answering participants' questions about the treatment materials, orienting participants to the upcoming treatment materials, encouraging practice of self-management skills, and answering queries about practicing the skills in the 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.

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 3 months post-treatment. These will take about 10-15 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] 287771 0
Treatment: Other
Intervention code [2] 287772 0
Behaviour
Comparator / control treatment
This 3 group (purely self-guided vs. self-guided with pre-treatment contact 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] 290272 0
Symptoms and severity of anxiety are measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [1] 290272 0
Administered at pre-treatment, prior to each Lesson in the course, at post-treatment, and at 3 months post-treatment
Primary outcome [2] 290273 0
Symptoms and severity of low mood/depression are measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 290273 0
Administered at pre-treatment, prior to each Lesson in the course, at post-treatment, and at 3 months post-treatment
Secondary outcome [1] 304233 0
Symptoms of low mood typified in an older population are measured by the Geriatric Depression Scale (GDS)
Timepoint [1] 304233 0
Administered at pre-treatment, post-treatment, and 3 months post-treatment
Secondary outcome [2] 304234 0
Psychological distress is measured with the Kessler-10 item (K-10)
Timepoint [2] 304234 0
Administered at pre-treatment, post-treatment, and 3 months post-treatment
Secondary outcome [3] 304235 0
Disability is measured by the Sheehan Disability Scales (SDS)
Timepoint [3] 304235 0
Administered at pre-treatment, post-treatment, and 3 months post-treatment
Secondary outcome [4] 304236 0
Life satisfaction is measured by the Satisfaction with Life Scale (SWLS)
Timepoint [4] 304236 0
Administered at pre-treatment, post-treatment, and 3 months post-treatment
Secondary outcome [5] 304237 0
Positive adaptive behaviours are measured by the Things You Do Questionnaire (TYDQ)
Timepoint [5] 304237 0
Administered at pre-treatment, post-treatment, and 3 months post-treatment

Eligibility
Key inclusion criteria
(1) Australian resident
(2) 60+ years of age
(3) Not currently participating in CBT for target symptoms
(4) Provides informed consent
(5) Reliable internet access
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Severe depression (i.e. score > 23 on PHQ-9), suicidal intention or plan
(2) Principal problem not anxiety or low mood/depression
(3) Self-reported suicide intent or plan

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
A total sample size of 450 participants is sufficient to observe the expected differences. With power at 80% and alpha of 0.05, 150 participants in each intervention group will allow detection of between-intervention group effect size differences of 0.3, the smallest effect size considered of clinical importance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2013
Actual
6/09/2013
Date of last participant enrolment
Anticipated
17/02/2014
Actual
9/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
434
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287815 0
Charities/Societies/Foundations
Name [1] 287815 0
beyondblue: the national depression initiative
Country [1] 287815 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] 286544 0
None
Name [1] 286544 0
Address [1] 286544 0
Country [1] 286544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289785 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 289785 0
Macquarie University
North Ryde
NSW 2109
Ethics committee country [1] 289785 0
Australia
Date submitted for ethics approval [1] 289785 0
Approval date [1] 289785 0
26/08/2013
Ethics approval number [1] 289785 0
5201300458

Summary
Brief summary
This project is part of a research program funded by beyondblue to develop and evaluate Internet based treatment programs for older adults (60+) with anxiety and depression. This project examines the relative efficacy of guided and self-guided internet delivered treatment. Additionally, the study aims to examine the effect of a pre-treatment interview upon treatment outcomes for self-guided interventions.

We expect that the guided intervention will result in superior outcomes to the self-guided interventions. Additionally, we expect that the self-guided intervention which includes a pre-treatment interview will result in superior outcomes when compared to the self-guided intervention without the interview.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
1. Dear, BF., Zou, J., Titov, N., Lorian, C., Johnston, L., Spence, J., Anderson, T., Sachdev, S., Brodaty, H., Knight, RG. (2013). Internet-delivered cognitive behavioural therapy for depression: A feasibility open trial for older adults. Australian and New Zealand Journal of Psychiatry, 47, 169-176.

2. Titov, N., Dear, B. F., Johnston, L., Lorian, C., Zou, J., Wootton, B., McEvoy, P. M., Rapee, R. M. (2013). Improving adherence and clinical outcomes in self-guided internet treatment for anxiety and depression: randomised controlled trial. PLoS One, 262873.

3. Zou, B.J., Dear, B.F., Titov, N., Lorian, C.N., Johnston, L., Spence, J., Knight, R.G., Anderson, T., Sachdev, P. (2012). Brief internet-delivered cognitive behavioral therapy for anxiety in older adults: A feasibility trial. Journal of Anxiety Disorders, 26, 650-655.
Public notes

Contacts
Principal investigator
Name 42298 0
A/Prof Nickolai Titov
Address 42298 0
Centre for Emotional Health, Department of Psychology, Building/Room C3A 724 Macquarie University North Ryde NSW 2109
Country 42298 0
Australia
Phone 42298 0
+61 2 9850 9901
Fax 42298 0
+61 2 9850 8062
Email 42298 0
[email protected]
Contact person for public queries
Name 42299 0
Nickolai Titov
Address 42299 0
Centre for Emotional Health, Department of Psychology, Building/Room C3A 724 Macquarie University North Ryde NSW 2109
Country 42299 0
Australia
Phone 42299 0
+61 2 9850 9901
Fax 42299 0
+61 2 9850 8062
Email 42299 0
[email protected]
Contact person for scientific queries
Name 42300 0
Nickolai Titov
Address 42300 0
Centre for Emotional Health, Department of Psychology, Building/Room C3A 724 Macquarie University North Ryde NSW 2109
Country 42300 0
Australia
Phone 42300 0
+61 2 9850 9901
Fax 42300 0
+61 2 9850 8062
Email 42300 0
[email protected]

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