Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001046897
Ethics application status
Approved
Date submitted
27/09/2012
Date registered
2/10/2012
Date last updated
2/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A naturalistic evaluation of the use of Anxiety Online by clients of a national provider of employment services
Scientific title
Evaluation of clinical severity and psychological distress following job seekers' use of the online mental health treatment service, Anxiety Online
Secondary ID [1] 273536 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders 279338 0
Depression 279339 0
Condition category
Condition code
Mental Health 279522 279522 0 0
Anxiety
Mental Health 279523 279523 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online treatment programs for Depression and each of the anxiety disorders: Generalised Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Post Traumatic Stress Disorder and Social Anxiety Disorder. Participants can do the program on their own (anxiety and depression programs) or with online assistance from a therapist (anxiety programs only). Programs are based on cognitive behaviour therapy techniques and contain 12 multi-media enriched modules with homework exercises designed to be completed over 12 weeks. It is anticipated that participants will spend about 30 minutes a week reading through the online module and completing associated offline exercises.
Intervention code [1] 283849 0
Treatment: Other
Intervention code [2] 285795 0
Behaviour
Comparator / control treatment
No control group is being used for the anxiety programs, which are offered as part of a wider virtual psychology clinic (described in ACTRN12611000704998). Participants are given treatment options based on their completion of a comprehensive online assessment (e-PASS). Comparisons are being made for fully automated self-help and therapist-assisted versions of each of the anxiety disorder treatment programs.

However, the Obsessive-Compulsive Disorder (OCD) program is also available through a wider research trial (ACTRN12611000321943), in which the online program with therapist assistance, is being compared with an automated self-help relaxation program.

The Depression program is also offered as part of a wider research trial (ACTRN12611000215921), in which a self-monitoring waitlist control group (SMWLC) is compared against a group getting the fully automated online depression program (no therapist assistance).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286102 0
For all programs: Anxiety disorders (Generalised Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Disorder with or without agoraphobia, Post Traumatic Stress Disorder, Social Anxiety Disorder) clinical disorder severity ratings, as measured by online assessment (e-PASS) based on DSM-IV-TR criteria and currently undergoing validity testing.
For OCD research trial only: Anxiety symptoms will also be measured by the Yale-Brown Obsessive-Compulsive Scale, Revised Obsessional Beliefs Questionnaire, and the Hamilton Anxiety Rating Scale.
Timepoint [1] 286102 0
For all programs: Pre-program, post-program (week 12), then annually from 1-year post-program through to 5-years post-program.
For OCD research trial: The additional measures will be obtained at pre-program, post-program and follow-up (6 months post-program).
Primary outcome [2] 286103 0
For all programs: Depression, as measured by online assessment (e-PASS) based on DSM-IV-TR criteria and currently undergoing validity testing.
For Depression program only: Depression is also being measured by scores on the Centre for Epidemiological Studies - Depression Scale (CES-D) and the Depression, Anxiety and Stress Scale - 21 (DASS-21).
For OCD research trial: Depression symptoms will also be measured with the Hamilton Depression Rating Scale.
Timepoint [2] 286103 0
e-PASS depression diagnosis (all programs): Pre-program, post-program (week 12), then annually from 1-year post-program through to 5-years post-program.
For additional measures for Depression program: Pre-program and post-program (week 12).
For additional measures for OCD research trial: pre-program, post-program and 6-month follow-up
Primary outcome [3] 286104 0
For all programs: Psychological distress, as measured by the Kessler-6.
Timepoint [3] 286104 0
Pre-program, post-program (week 12), then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [1] 295149 0
For all programs: Eating disorders (anorexia nervosa, bulimia nervosa, binge eating disorder), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing.
Timepoint [1] 295149 0
Pre-program, post-program (week 12), then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [2] 295150 0
For all programs: Somatoform disorders (somatisation, body dysmorphic disorder), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing.
Timepoint [2] 295150 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [3] 295151 0
For all programs: Pathological gambling, as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing.
Timepoint [3] 295151 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [4] 295152 0
For all programs: Sleeping disorders (insomnia, hypersomnia), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing.
Timepoint [4] 295152 0
Pre-program, post-program (week 12), then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [5] 295153 0
For all programs: Dependence disorders (alcohol dependence and substance dependence), as measured by online assessment (e-PASS) based on DSM-IV criteria and currently undergoing validity testing.
Timepoint [5] 295153 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [6] 295154 0
For all programs: Quality of life rating, as measured by Likert-type scale within an online assessment.
For OCD research trial: Quality of life will also be measured with the Australian Quality of Life Scale.
Timepoint [6] 295154 0
Pre-program, post-program (week 12), then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [7] 295155 0
For all programs: Confidence in managing mental health, as measured by a Likert-type scale within an online assessment.
Timepoint [7] 295155 0
Pre-program, post-program (week 12) then annually from 1-year post-program through to 5-years post-program.
Secondary outcome [8] 295156 0
For all programs: Likert-scale based questions (largely self-developed) are used to measure treatment satisfaction and self-perceived improvement, as well as open-ended questions regarding the best and worst aspects of the program and how the program could be improved.
Timepoint [8] 295156 0
Post-program (week 12).
Secondary outcome [9] 295157 0
For all programs: Client's perceptions of the helpfulness of their relationship with their therapist - as measured by the Working Alliance Questionnaire.
Timepoint [9] 295157 0
Post-program (week 12) for those consumers accessing therapist-assisted programs.
Secondary outcome [10] 295158 0
For all programs: Number of mental health disorder diagnoses, as measured by the number of diagnoses on a person's online assessment (e-PASS report).
Timepoint [10] 295158 0
Pre-program, post-program (week 12), then annually from 1-year post-program through to 5 years post-program.
Secondary outcome [11] 295159 0
For depression program only: Dysfunctional Attitude Scale (DAS).
Timepoint [11] 295159 0
Pre-program, month 1, month 2, month 3 (post-program) and month 6 (follow-up).
Secondary outcome [12] 295160 0
For OCD research trial only: general disability, as measured by the Brief Disability Questionnaire
Timepoint [12] 295160 0
Pre-program, post-program and 6-month follow-up
Secondary outcome [13] 295161 0
For OCD research trial only: Self-ambivalence, as measured by the Self-Ambivalence Measure.
Timepoint [13] 295161 0
Pre-program, post-program and 6-months follow-up.

Eligibility
Key inclusion criteria
Individuals must be job seeker clients of Advanced Personnel Management, 18 years of age or older up to 65 years of age and able to access the internet. To be clients of Advanced Personnel Management they will have a physical or mental health disability, injury or health condition impacting on their ability to work.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18, no internet access. For the therapist-assisted programs (but not the fully automated self-help programs) not an Australian resident.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This trial is using a naturalistic design whereby participants are invited to undertake an online assessment, are provided with treatment recommendations but can choose which, if any treatment recommendations they take up. Depending on their symptoms they may be able to choose to undertake either a therapist-assisted or self-help program (anxiety treatment programs) or they can choose to take part in a randomised controlled trial (depression and OCD programs). See ACTRN12611000215921 (depression program trial) and ACTRN12611000321943.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants receive different online treatment programs depending on their e-PASS results and personal choice as to which online program to complete. They complete programs at different time points as registration is open continuously during the recruitment period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284336 0
Commercial sector/Industry
Name [1] 284336 0
Advanced Personnel Management
Country [1] 284336 0
Australia
Primary sponsor type
University
Name
National eTherapy Centre and BPsyC eTherapy Research Unit, Swinburne University
Address
Mail H99, PO Box 218, Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 283278 0
None
Name [1] 283278 0
Address [1] 283278 0
Country [1] 283278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286296 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 286296 0
Ethics committee country [1] 286296 0
Australia
Date submitted for ethics approval [1] 286296 0
25/11/2011
Approval date [1] 286296 0
15/02/2012
Ethics approval number [1] 286296 0
SUHREC Project 2011/278

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

Contacts
Principal investigator
Name 33497 0
Address 33497 0
Country 33497 0
Phone 33497 0
Fax 33497 0
Email 33497 0
Contact person for public queries
Name 16744 0
Dr Jo Abbott
Address 16744 0
National eTherapy Centre, Faculty of Life and Social Sciences, Swinburne University of Technology, Mail H99, PO Box 218, Hawthorn, VIC, 3122
Country 16744 0
Australia
Phone 16744 0
+61 3 9214 5866
Fax 16744 0
Email 16744 0
[email protected]
Contact person for scientific queries
Name 7672 0
Dr Jo Abbott
Address 7672 0
National eTherapy Centre, Faculty of Life and Social Sciences, Swinburne University of Technology, Mail H99, PO Box 218, Hawthorn, VIC, 3122
Country 7672 0
Australia
Phone 7672 0
+61 3 9214 5866
Fax 7672 0
Email 7672 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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