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Trial registered on ANZCTR


Registration number
ACTRN12611000927921
Ethics application status
Approved
Date submitted
23/08/2011
Date registered
29/08/2011
Date last updated
7/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized Controlled Trial (RCT) of Internet-based Treatment of Depression 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 depression.
Secondary ID [1] 262898 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 270629 0
Condition category
Condition code
Mental Health 270796 270796 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this open trial participants will receive access to an 8 week internet-based treatment program. All participants will have at least mild symptoms of depression(PHQ- 9 total score of >9). All participants will complete 5 lessons of Internet based treatment about management of symptoms of depression. 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, a secure online clinician-moderated forum, and will read anonymous stories about other people with depression, taking a further 20 minutes per week. All participants will also receive automatic emails and brief weekly (<10minutes week) supportive telephone calls from a Registered Psychologist.

Study questionnaires will be administered at application, pre-treatment, post-treatment, and at 3-months post-treatment. These will take about 20-30 minutes to complete. The treatment materials are based on the Wellbeing Course, which teaches evidence-based cognitive behavioural skills.
Intervention code [1] 269249 0
Treatment: Other
Intervention code [2] 269295 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] 279489 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 279489 0
Administered at pre-treatment, prior to each Lesson in the program, post-treatment, and at 3-months post-treatment
Primary outcome [2] 279490 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).
Timepoint [2] 279490 0
Administered at pre-treatment, prior to each Lesson in the program, post-treatment, and at 3-months post-treatment
Primary outcome [3] 279491 0
Symptoms and severity of depression is measured by the Geriatric Depression Scale (GDS)
Timepoint [3] 279491 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [1] 287737 0
Depression, Anxiety and Stress is measured by the Depression, Anxiety, Stress Scale (21 item) (DASS-21).
Timepoint [1] 287737 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [2] 287744 0
Health status is measured by the European Quality of Life-5 dimensions- 5 level (EQ-5D-5L).
Timepoint [2] 287744 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [3] 287745 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] 287745 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [4] 287746 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale.
Timepoint [4] 287746 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [5] 287747 0
Perception of cognitive health is measured by the Cognitive Failures Questionnaire (CFQ).
Timepoint [5] 287747 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [6] 287748 0
Positive adaptive behaviours are measured by the Things You Do Questionnaire (TYD).
Timepoint [6] 287748 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.

Eligibility
Key inclusion criteria
- Resident of Australia
- Have access to a computer, the Internet, and use of a printer
- Not currently participating in CBT
- Not using illicit drugs or consuming more than three standard drinks/day
- 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)
- Reports that they have been assessed by a GP or specialist to rule out a physical cause for their depression
- A total score >9 on the PHQ-9 (indicating at least elevated symptoms of depression). Note that meeting diagnostic criteria for depression is NOT an inclusion criteria – instead, participants need to have elevated symptoms of depression as measured by the PHQ-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
- Prepared to provide name, phone number and address, and to provide the name and address of a local general practitioner
- 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
- Severe depression (score of 20 or greater on PHQ-9)
- Suicidal intent or plan
- Scoring below cut-off on the PHQ-9
- Current substance abuse
- Psychosis
- Presenting problem not 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 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] 269722 0
Charities/Societies/Foundations
Name [1] 269722 0
beyondblue
Address [1] 269722 0
PO Box 6100
Hawthorn West
VIC 3122
Country [1] 269722 0
Australia
Primary sponsor type
University
Name
Department of Psychology, Macquarie University
Address
Department of Psychology
Building C3A
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 268762 0
None
Name [1] 268762 0
Address [1] 268762 0
Country [1] 268762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271685 0
Human Research Ethics Committee
Ethics committee address [1] 271685 0
Macquarie University
North Ryde
NSW 2109
Ethics committee country [1] 271685 0
Australia
Date submitted for ethics approval [1] 271685 0
Approval date [1] 271685 0
15/07/2011
Ethics approval number [1] 271685 0
5201100469

Summary
Brief summary
The purpose of this project is to explore the efficacy of a clinician-guided treatment program for symptoms of depression in older adults (aged 60-75), administered over the internet in a Ramdomised Controlled Trial. A secondary purpose is to determine the acceptability of the treatment protocol and materials to older adults with symptoms of depression. A tertiary purpose of this project is to explore the efficacy of a self-guided version of the program, with participants from the Waitlist Control Group.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
1. Andrews G, Cuijpers P, Craske M, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: A meta-analysis. PLoS ONE 5(10): e13196. doi:10.1371/journal.pone.0013196.
2. Titov N, Andrews G, Schwencke G, Robinson E, Peters L, Spence J. An RCT of Internet CBT for social phobia with and without motivational enhancement strategies. Aust N Z J Psychiatry 2010;44:938-945.
3. Wootton BM, Titov N. Distance treatment of obsessive compulsive disorder. Behaviour Change 2010;27:112-118.
4. Wims E, Titov N, Andrews G, Choi I. Clinician-assisted Internet-based treatment is effective for panic: A randomized controlled trial. Aust N Z J Psychiatry 2010;44:599-607.
5. Andrews G, Titov N. Alternate models of care. Treating people you never see: Internet-based treatment of the internalizing mental disorders. Aust Health Rev 2010; 34: 145–8. doi:10.1071/AH09775.
6. 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
7. Titov N, Sachdev P, Andrews G. Computer-delivered cognitive behavioural therapy (CCBT) – Effective and getting ready for dissemination. F1000 Medicine Reports 2010, 2:49. doi:10.3410/M2-49.
8. Andrews G, Titov N. Is Internet treatment ready for prime time? MJA 2010; 192 (11): S45-S47.
9. Titov N, Andrews G, Davies M, McIntyre K, Robinson E, Solley K. Internet treatment for depression: A randomized controlled trial comparing clinician vs. technician assistance. PLoS ONE 2010, 5(6): e10939. doi:10.1371/journal.pone.0010939.
10. Robinson E, Titov N, Andrews G, McIntyre K, Schwencke G, Solley K. Internet treatment for generalized anxiety disorder: A randomized controlled trial comparing clinician vs. technician assistance. PLoS ONE 2010, 5(6): e10942. doi:10.1371/journal.pone.0010942.
11. Titov N, Andrews G, Kemp A, Robinson E. Characteristics of adults with anxiety or depression treated at an Internet clinic: Comparison with a national survey and an outpatient clinic. PLoS ONE 2010, 5(5): e10885. doi:10.1371/journal.pone.0010885.
12. Andrews G, Titov N. Hit and Miss: Innovation and dissemination of evidence based psychological treatments. Behav Res Ther 2009; 47:974-979.
13. Andrews G, Titov N, Schwencke G. Editorial: Meeting unmet need: Severe depression in applicants to an Internet treatment program for social phobia. Psychiatr Bull 2009; 33:407-408.
14. Aydos LR, Titov N, Andrews G. Shyness 5: The clinical effectiveness of Internet-based clinician-assisted treatment of social phobia. Australas Psychiatry 2009; 17:488-492.
15. Perini S, Titov N, Andrews G. Clinician-assisted Internet-based treatment is effective for depression: A randomized controlled trial. Aust N Z J Psychiatry 2009;43:571-578.
16. Titov N, Andrews G, Choi I, Schwencke G, Johnston L. Randomized controlled trial of web-based treatment of social phobia without clinical guidance. Aust N Z J Psychiatry 2009;43:913-919.
17. Titov N, Andrews G, Johnston J, Schwencke G, Choi I. The Shyness program: Longer term benefits, cost-effectiveness, and acceptability. Aust N Z J Psychiatry 2009;43:36-44.
18. Titov N, Andrews G, Robinson E, Schwencke G, Johnston L, Solley K, Choi I. Clinician-assisted Internet-based treatment is effective for generalized anxiety disorder: A randomized controlled trial. Aust N Z J Psychiatry 2009;43:905-912.
19. Titov N, Andrews G, Schwencke G, Solley K, Johnston L, Robinson E. An RCT comparing two types of support on severity of symptoms for people completing Internet-based cognitive behavior therapy for social phobia. Aust N Z J Psychiatry 2009;43:920-926.
20. Titov N, Gibson M, Andrews G, McEvoy P. Internet treatment for social phobia reduces comorbidity. Aust N Z J Psychiatry 2009;43:754-759.
21. Titov N, Andrews G, Choi I, Schwencke G, Mahoney J. Shyness 3: An RCT of guided versus unguided Internet based CBT for social phobia. Aust N Z J Psychiatry 2008;42:1030-1040.
22. Titov N. The status of computerized cognitive behavioural therapy (CCBT) for adults: A review. Aust N Z J Psychiatry 2007;41:95-114.
Public notes

Contacts
Principal investigator
Name 33063 0
Prof Nickolai Titov
Address 33063 0
Centre for Emotional Health Department of Psychology, C3B 518 Macquarie University NSW 2109
Country 33063 0
Australia
Phone 33063 0
+61 2 98509901
Fax 33063 0
Email 33063 0
nick.titov@mq.edu.au
Contact person for public queries
Name 16310 0
Prof Associate Professor Nickolai Titov
Address 16310 0
Centre for Emotional Health
Department of Psychology, C3B 518
Macquarie University NSW 2109
Country 16310 0
Australia
Phone 16310 0
+61 (0) 2 9850 9901
Fax 16310 0
+61 (0) 2 9850 8062
Email 16310 0
nick.titov@mq.edu.au
Contact person for scientific queries
Name 7238 0
Prof Associate Professor Nickolai Titov
Address 7238 0
Centre for Emotional Health
Department of Psychology, C3B 518
Macquarie University NSW 2109
Country 7238 0
Australia
Phone 7238 0
+61 (0) 2 9850 9901
Fax 7238 0
+61 (0) 2 9850 8062
Email 7238 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