Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000010998
Ethics application status
Approved
Date submitted
21/12/2010
Date registered
6/01/2011
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An open trial of internet-based treatment of anxiety symptoms in older adults
Scientific title
An open trial of internet-based treatment of anxiety symptoms in older adults
Secondary ID [1] 253319 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 258858 0
Condition category
Condition code
Mental Health 258997 258997 0 0
Anxiety

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 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, a secure online clinician-moderated forum, 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, and 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] 257773 0
Treatment: Other
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259845 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).
Timepoint [1] 259845 0
Administered at pre-treatment, prior to each Lesson in the program, post-treatment, and at 3-months post-treatment
Primary outcome [2] 259846 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [2] 259846 0
Administered at pre-treatment, prior to each Lesson in the program, post-treatment, and at 3-months post-treatment
Primary outcome [3] 259847 0
Symptoms and severity of depression is measured by the Geriatric Depression Scale (GDS)
Timepoint [3] 259847 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [1] 268709 0
Depression, Anxiety and Stress is measured by the Depression, Anxiety, Stress Scale (21 item) (DASS-21).
Timepoint [1] 268709 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [2] 268710 0
Disability will be measured by the World Health Organisation Disability Assessment Schedule 2nd Edition (WHODAS-II).
Timepoint [2] 268710 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment.
Secondary outcome [3] 268711 0
Psychological distress is measured by the Kessler 10-item scale (K-10).
Timepoint [3] 268711 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [4] 268712 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale.
Timepoint [4] 268712 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [5] 268713 0
Perception of cognitive health is measured by the Cognitive Failures Questionnaire (CFQ).
Timepoint [5] 268713 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 anxiety
- 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
- 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
Sex
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 GAD-7
- Current substance abuse
- Psychosis
- Presenting problem not anxiety

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online, followed by a telephone interview to identify psychiatric diagnoses using the Mini Neuropsychiatric Interview Schedule (MINI 5.0.0).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/02/2011
Actual
7/02/2011
Date of last participant enrolment
Anticipated
1/03/2011
Actual
1/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258237 0
Charities/Societies/Foundations
Name [1] 258237 0
beyondblue
Country [1] 258237 0
Australia
Primary sponsor type
Hospital
Name
Clinical Research Unit for Anxiety and Depression (CRUfAD), St Vincent's Hospital (Sydney)
Address
CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst NSW 2010, Australia
Country
Australia
Secondary sponsor category [1] 257404 0
University
Name [1] 257404 0
Clinical Research Unit for Anxiety and Depression (CRUfAD), School of Psychiatry, University of New South Wales
Address [1] 257404 0
CRUfAD, Level 4, O'Brien Center, 390 Victoria Street, Darlinghurst NSW 2010, Australia
Country [1] 257404 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260218 0
St Vincent's Hospital (Sydney) Human Research Ethics Committe
Ethics committee address [1] 260218 0
Ethics committee country [1] 260218 0
Australia
Date submitted for ethics approval [1] 260218 0
Approval date [1] 260218 0
15/12/2010
Ethics approval number [1] 260218 0
HREC/10/SVH/110

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32033 0
Prof Nick Titov
Address 32033 0
Department of Psychology
Macquarie University
NSW 2109
Country 32033 0
Australia
Phone 32033 0
61 2 9850 9979
Fax 32033 0
Email 32033 0
[email protected]
Contact person for public queries
Name 15280 0
Dr Nickolai Titov
Address 15280 0
CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst NSW 2010, Australia
Country 15280 0
Australia
Phone 15280 0
+61 2 8382 1406
Fax 15280 0
+61 2 8382 1401
Email 15280 0
[email protected]
Contact person for scientific queries
Name 6208 0
Dr Nickolai Titov
Address 6208 0
CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst NSW 2010, Australia
Country 6208 0
Australia
Phone 6208 0
+61 2 8382 1406
Fax 6208 0
+61 2 8382 1401
Email 6208 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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