ANZCTR - Registration

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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]

Nil.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

None.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7).

Timepoint [1]

Administered at pre-treatment, prior to each Lesson in the program, post-treatment, and at 3-months post-treatment

Primary outcome [2]

Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)

Timepoint [2]

Administered at pre-treatment, prior to each Lesson in the program, post-treatment, and at 3-months post-treatment

Primary outcome [3]

Symptoms and severity of depression is measured by the Geriatric Depression Scale (GDS)

Timepoint [3]

Administered at pre-treatment, post-treatment, and at 3-months post-treatment.

Secondary outcome [1]

Depression, Anxiety and Stress is measured by the Depression, Anxiety, Stress Scale (21 item) (DASS-21).

Timepoint [1]

Administered at pre-treatment, post-treatment, and at 3-months post-treatment.

Secondary outcome [2]

Disability will be measured by the World Health Organisation Disability Assessment Schedule 2nd Edition (WHODAS-II).

Timepoint [2]

Administered at pre-treatment, post-treatment, and at 3-months post-treatment.

Secondary outcome [3]

Psychological distress is measured by the Kessler 10-item scale (K-10).

Timepoint [3]

Administered at pre-treatment, post-treatment, and at 3-months post-treatment

Secondary outcome [4]

Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale.

Timepoint [4]

Administered at pre-treatment, post-treatment, and at 3-months post-treatment

Secondary outcome [5]

Perception of cognitive health is measured by the Cognitive Failures Questionnaire (CFQ).

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

beyondblue

Address [1]

PO Box 6100
Hawthorn West
VIC3122

Country [1]

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]

University

Name [1]

Clinical Research Unit for Anxiety and Depression (CRUfAD), School of Psychiatry, University of New South Wales

Address [1]

CRUfAD, Level 4, O'Brien Center, 390 Victoria Street, Darlinghurst NSW 2010, Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital (Sydney) Human Research Ethics Committe

Ethics committee address [1]

390 Victoria Street, Darlinghurst NSW 2010, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/12/2010

Ethics approval number [1]

HREC/10/SVH/110

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.virtualclinic.org.au

Trial related presentations / publications

- Andrews, G. and N. Titov, Alternate models of care. Treating people you never see: Internet-based treatment of the internalizing mental disorders. Australian Health Review, In Press. 
- Titov, N., et al., The Shyness Program: Longer Term Benefits, Cost-Effectiveness, and Acceptability. Australian & New Zealand Journal of Psychiatry, 2009. 43(1): p. 36-44. 
- Titov, N, G. Andrews, and P.M. McEvoy, Key components in low intensity interventions for anxiety. Oxford Guide, submitted 
- Titov, N. & G. Andrews, Email and brief internet based mental health interventions. Oxford Guide, submitted. 
- Titov, N., et al., Brief Internet Treatment for Social Phobia reduces Comorbidity Australian and New Zealand Journal of Psychiatry in press. 
- Titov N, Andrews G, Schwencke G: Shyness 2: Treating social phobia online: replication and extension. Australian and New Zealand Journal of Psychiatry 2008 42(7):595-605. 
- Titov N, Andrews G, Schwencke G, Drobny J, Einstein D: Shyness 1: Distance treatment for social over the Internet. A randomized controlled trial. Australian & New Zealand Journal of Psychiatry 2008; 42(7):585-594. 
- Titov N, Andrews G, Choi I, Schwencke G, Mahoney A: Shyness 3: An RCT of guided vs unguided internet based CBT for social phobia. Australian & New Zealand Journal of Psychiatry 2008; 42(12):1030-1040. 
- Titov N. Status of computerized cognitive behavioural therapy for adults. Australian & New Zealand Journal of Psychiatry 2007; 41(2):95-114. 
- Titov N, Andrews G, Robinson E, Schwencke G, Johnston L, Solley K, Choi I. Clinician-assisted internet treatment is effective for generalized anxiety disorder: randomized controlled trial. Australian and New Zealand Journal of Psychiatry 2009, 43:10, 905-912. 
- Titov, N., Dear, B. F., Schwencke, G., Andrews, G., Johnston, L., Craske, M., & McEvoy, P. (submitted). Transdiagnostic internet treatment for anxiety and depression: 
A randomised controlled trial. Behaviour Research and Therapy.
- Wims E, Titov N, Andrews G: The Climate Panic program: an open trial of Internet-based treatment for panic disorder. Electronic Journal of Applied Psychology 2008; 4(2)

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

Public notes

Contacts

Principal investigator

Name

Prof Nick Titov

Address

Department of Psychology
Macquarie University
NSW 2109

Country

Australia

Phone

61 2 9850 9979

Fax

nick.titov@mq.edu.au

Contact person for public queries

Name

Dr Nickolai Titov

Address

CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst NSW 2010, Australia

Country

Australia

Phone

+61 2 8382 1406

Fax

+61 2 8382 1401

nickt@unsw.edu.au

Contact person for scientific queries

Name

Dr Nickolai Titov

Address

CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst NSW 2010, Australia

Country

Australia

Phone

+61 2 8382 1406

Fax

+61 2 8382 1401

nickt@unsw.edu.au

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

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