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Trial registered on ANZCTR


Registration number
ACTRN12611000929909
Ethics application status
Approved
Date submitted
23/08/2011
Date registered
30/08/2011
Date last updated
4/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized Controlled Trial (RCT) of Internet-based Treatment of Anxiety Symptoms in Older Adults
Scientific title
A randomised controlled trial of Internet based treatment for older adults comparing Immediate treatment vs. delayed treatment on symptoms of anxiety.
Secondary ID [1] 262897 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 270628 0
Condition category
Condition code
Mental Health 270795 270795 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1)an immediate treatment group, or; 2) a delayed waitlist control group (beginning 9 weeks after the immediate treatment group begin. Participants will receive access to an 8 week internet-based treatment program.All participants will have at least mild symptoms of anxiety (GAD-7 total score >7). All participants will complete 5 lessons of Internet based treatment about management of symptoms of anxiety and stress. 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 summaries of each lesson, and will read anonymous stories about other people with anxiety, taking a further 20 minutes per week. All participants will also receive automatic emails and brief weekly (<10minutes week) supportive telephone calls from a clinical psychologist.

Study questionnaires will be administered at application, pre-treatment, post-treatment, at 3-months post-treatment. These will take about 20-30 minutes to complete. The treatment materials are based on the Wellbeing Program, which teaches evidence-based cognitive behavioural skills.
Intervention code [1] 269250 0
Treatment: Other
Intervention code [2] 269294 0
Behaviour
Comparator / control treatment
The delayed waitlist control goup (beginning the course 9 weeks after the immediate treatment group beings). This is a wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 279493 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).
Timepoint [1] 279493 0
Administered at pre-treatment, prior to each Lesson in the course, post-treatment, and at 3-months post-treatment
Primary outcome [2] 279494 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 279494 0
Administered at pre-treatment, prior to each Lesson in the course, post-treatment, and at 3-months post-treatment
Primary outcome [3] 279495 0
Symptoms and severity of depression is measured by the Geriatric Depression Scale (GDS)
Timepoint [3] 279495 0
Administered at pre-treatment, prior to each Lesson in the course, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 287738 0
Depression, Anxiety and Stress is measured by the Depression, Anxiety, Stress Scale (21 item) (DASS-21).
Timepoint [1] 287738 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [2] 287739 0
Health status is measured by the European Quality of Life-5 Dimensions: 5 level version (EQ-5D-5L).
Timepoint [2] 287739 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [3] 287740 0
Health service use (Number of visits to different health professionals, impact of anxiety and depression on absenteeism and reduced productivity, and impact on any caregivers) is measured by the Service Use Quesionnaire (based on the Adult Service Use Schedule (AD-SUS, Byford et al., 2010)).
Timepoint [3] 287740 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [4] 287741 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale.
Timepoint [4] 287741 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [5] 287742 0
Perception of cognitive health is measured by the Cognitive Failures Questionnaire (CFQ).
Timepoint [5] 287742 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [6] 287743 0
Positive and adaptive behaviours are measured by the Things You Do Questionnaire (TYDQ)
Timepoint [6] 287743 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment

Eligibility
Key inclusion criteria
1. Resident of Australia
2. 60 years – 75 years of age
3. Have access to a computer, the Internet, and use of a printer
4. Not currently participating in CBT
5. Not using illicit drugs or consuming more than three standard drinks/day
6. Not currently experiencing a psychotic mental illness or severe symptoms of depression (defined as a total score >19 or responding >2 to Question 9 [suicidal ideation] on the PHQ-9)
7. Reports that they have been assessed by a GP or specialist to rule out a physical cause for their anxiety
8. A total score >7 on the GAD-7 (indicating at least mild symptoms of anxiety). Note that meeting diagnostic criteria for a formal anxiety disorder is NOT an inclusion criteria – instead, participants need to have elevated symptoms of anxiety as measured by the GAD-7
9. If taking medication for anxiety or depression, been taking the same dose for at least 1 month and not intend to change that dose during the course of the program
10. Prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner
11. Prepared to provide informed consent
Minimum age
60 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe depression (score of 20 or greater on PHQ-9)
2. Suicidal intent or plan
3. Scoring below cut-off on the GAD-7
4. Current substance abuse
5. Psychosis
6. Presenting problem not anxiety

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 administered a telephone interview to identify psychiatric diagnoses using the Mini Neuropsychiatric Interview Schedule (MINI 5.0.0). Participants are then randomly allocated to one of the two 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
Open (masking not 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)

Funding & Sponsors
Funding source category [1] 269721 0
Charities/Societies/Foundations
Name [1] 269721 0
beyondblue
Address [1] 269721 0
PO Box 6100
Hawthorn West
VIC3122
Country [1] 269721 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, North Ryde,
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 268761 0
None
Name [1] 268761 0
Address [1] 268761 0
Country [1] 268761 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271686 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 271686 0
E11A, Macquarie University NSW 2109
Ethics committee country [1] 271686 0
Australia
Date submitted for ethics approval [1] 271686 0
10/05/2011
Approval date [1] 271686 0
15/07/2011
Ethics approval number [1] 271686 0
5201100470

Summary
Brief summary
The purpose of this project is to explore whether a clinician-guided treatment program can help to reduce anxiety symptoms in a population of mature adults (aged 60-75), when administered over the internet. A secondary purpose is to determine how acceptable people find this form of treatment. The study will inform how services can best improve future treatment programs for mature adults with anxiety.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
1. Gun, S.Y., Titov, N., Andrews G. (2011). Acceptability of Internet treatment of anxiety and depression. Australasian Psychiatry, 19(3), 259-264.
2. Titov, N. (2011). Internet-delivered psychotherapy for depression in adults. Current Opinion in Psychiatry, 24, 18-23.
3. Andrews, G., Cuijpers, P., Craske, M., McEvoy, P., & Titov, N. (2010). Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: A meta-analysis. PLoS ONE, 5: e13196.
4. Andrews, G., & Titov, N. (2010). Is Internet treatment ready for prime time? Medical Journal of Australia, 192, S45-S47.
5. Titov, N., Sachdev, P., & Andrews, G. (2010). Computer-delivered cognitive behavioural therapy (CCBT) – Effective and getting ready for dissemination. F1000 Medicine Reports, 2, 49.
6. Titov, N., Andrews, G., Kemp, A., & Robinson, E. (2010). Characteristics of adults with anxiety or depression treated at an Internet clinic: Comparison with a national survey and an outpatient clinic. PLoS ONE, 5.
7. Andrews, G., & Titov, N. (2009). Hit and Miss: Innovation and dissemination of evidence based psychological treatments. Behaviour Research and Therapy, 47, 974-979.
8. Titov, N. (2007). The status of computerized cognitive behavioural therapy (CCBT) for adults: A review. Australian and New Zealand Journal of Psychiatry, 41, 95-114.
9. Dear, B. F., Titov, N., Sunderland, M., McMillan, D., Anderson, T., Lorian, C. & Robinson, E. (In press). Psychometric comparison of the GAD-7 and the PSWQ for measuring response during treatment of generalised anxiety disorder. Cognitive Behaviour Therapy.
10. 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, e10942.
11. Titov, N., Andrews, G., Robinson, E., Schwencke, G., Johnston, L., Solley, K., & Choi, I. (2009). Clinician-assisted internet treatment is effective for generalized anxiety disorder: randomized controlled trial. Australian and New Zealand Journal of Psychiatry, 43, 905-912.
12. 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.
13. Wims, E., Titov, N., & Andrews, G. (2008). The Climate Panic program: an open trial of Internet-based treatment for panic disorder. Electronic Journal of Applied Psychology, 4.
14. Andrews, G., Davies, M., & Titov, N. (2011). An effectiveness randomized controlled trial of face to face versus internet cognitive behaviour therapy for social phobia. Australian and New Zealand Journal of Psychiatry. 45, 337 - 340.
15. 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.
16. Titov, N., Gibson, M., Andrews, G., & McEvoy, P. (2009). Internet treatment for social phobia reduces comorbidity. Australian and New Zealand Journal of Psychiatry, 43, 754 – 759.
17. Titov, N., Andrews, G., Schwencke, G., Solley, K., Johnston, L., & Robinson, E. (2009). An RCT comparing effect of two types of support on severity of symptoms for people completing Internet-based cognitive behaviour therapy for social phobia. Australian and New Zealand Journal of Psychiatry, 43, 920 - 926.
18. Titov, N., Andrews, G., Choi, I., Schwencke, G., & Johnston, L. (2009). Randomized controlled trial of web-based treatment of social phobia without clinician guidance. Australian and New Zealand Journal of Psychiatry, 43, 913 - 919.
19. Titov, N., Andrews, G., Johnston, L., Schwencke, G., & Choi, I. (2009). The Shyness Program: Longer Term Benefits, Cost-Effectiveness, and Acceptability. Australian & New Zealand Journal of Psychiatry 43, 36 - 44.
20. Aydos, L. R., Titov, N., & Andrews, G. (2009). Shyness 5: The clinical effectiveness of Internet-based clinician-assisted treatment of social phobia. Australasian Psychiatry, 17, 488 - 492.
21. Titov, N., Andrews, G., Choi, I., Schwencke, G., & Mahoney, A. (2008). Shyness 3: An RCT of guided vs unguided internet based CBT for social phobia. Australian & New Zealand Journal of Psychiatry, 42, 1030 - 1040.
22. Titov, N., Andrews, G., & Schwencke, G. (2008). Shyness 2: Treating social phobia online: replication and extension. Australian and New Zealand Journal of Psychiatry, 42, 595 - 605.
23. Titov, N., Andrews, G., Schwencke, G., Drobny, J., & Einstein, D. (2008). Shyness 1: Distance treatment for social over the Internet. A randomized controlled trial. Australian & New Zealand Journal of Psychiatry, 42, 585 - 594.
Public notes

Contacts
Principal investigator
Name 33062 0
Prof Nickolai Titov
Address 33062 0
Centre for Emotional Health, Macquarie University, Ryde, NSW, 2019
Country 33062 0
Australia
Phone 33062 0
+61 2 98509901
Fax 33062 0
Email 33062 0
nick.titov@mq.edu.au
Contact person for public queries
Name 16309 0
Prof Associate Professor Nickolai Titov
Address 16309 0
Centre for Emotional Health, Macquarie University, Ryde, NSW, 2019
Country 16309 0
Australia
Phone 16309 0
+612 9850 9901
Fax 16309 0
+612 9850 8062
Email 16309 0
nick.titov@mq.edu.au
Contact person for scientific queries
Name 7237 0
Prof Associate Professor Nickolai Titov
Address 7237 0
Centre for Emotional Health, Macquarie University, Ryde, NSW, 2019
Country 7237 0
Australia
Phone 7237 0
+612 9850 9901
Fax 7237 0
+612 9850 8062
Email 7237 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