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Trial registered on ANZCTR


Trial ID
ACTRN12615000577516
Ethics application status
Approved
Date submitted
18/05/2015
Date registered
3/06/2015
Date last updated
8/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-guided internet-administered cognitive-behavioural therapy for obsessive-compulsive disorder: A randomized controlled trial
Scientific title
A randomised controlled trial of a self-guided education program for Obsessive Compulsive Disorder comparing the efficacy of immediate treatment versus delayed treatment
Secondary ID [1] 283399 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obsessive compulsive disorder 290304 0
Condition category
Condition code
Mental Health 290694 290694 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the treatment groups will complete 5 lessons in 8 weeks of a self guided internet-delivered treatment program for OCD. All participants will be followed up 24 months after they complete the intervention. The content of the 5 lesson intervention includes:

Lesson One (1 week):
Learn about the physical, cognitive and behavioural symptoms of OCD and the principles of CBT treatment for OCD.

Lesson 2 (2 weeks):
Learn about the relationship between unhelpful thinking and anxiety. Read examples of how people with symptoms of OCD improve the accuracy of unhelpful thinking styles.

Lesson 3 (1 week):
Learn about the physical symptoms of OCD and read examples of how people learn to manage them.

Lesson 4 (2 weeks):
Learn about the unhelpful behaviours of OCD (compulsions and avoidance) and how to challenge those behaviours with exposure and response prevention.

Lesson 5 (2 weeks):
Learn about relapse prevention and staying well.

The immediate treatment group will complete the program immediately, whilst the delayed treatment condition will complete the program after a 8 week delay. Both groups receive the same information and participants will be asked questions about how much time they spent using the skills described in the program.

The internet-delivered lessons for both groups take approximately 30 minutes to read through, with homework exercises taking a further hour per day. The lessons are based on current best practice cognitive and behavioural techniques and include exposure and response prevention, and cognitive techniques. A printable information summary will also be provided, and some homework assignments will be set.
Intervention code [1] 288124 0
Behaviour
Intervention code [2] 292005 0
Treatment: Other
Comparator / control treatment
The waitlist control group will receive access to the program after the immediate group has completed the treatment (8 weeks).
Control group
Active

Outcomes
Primary outcome [1] 290708 0
Yale Brown Obsessive Compulsive Disorder Scale (YBOCS)
Timepoint [1] 290708 0
Baseline
Weekly through treatment
Post-education (week 8)
3-month follow up
12 month follow up
24 month follow up
Secondary outcome [1] 305074 0
Dimensional Obsessive Compulsive Scale
Timepoint [1] 305074 0
Baseline
Mid treatment (Week 5)
Post-treatment (week 10)
3 month follow up
12 month follow up
24 month follow up
Secondary outcome [2] 314051 0
Patient Health Questionnaire-9 Item (PHQ-9)
Timepoint [2] 314051 0
Baseline
Weekly through treatment
Post-education (week 8)
3-month follow up
12 month follow up
24 month follow up
Secondary outcome [3] 314052 0
Self-report Clinical Global Impression (CGI) (severity and improvement)
Timepoint [3] 314052 0
Baseline (severity only)
Weekly through treatment
Post-education (week 8)
3-month follow up
12 month follow up
24 month follow up
Secondary outcome [4] 314053 0
Adherence questionnaire (designed specifically for this study)
Timepoint [4] 314053 0
Weekly through treatment
Secondary outcome [5] 314054 0
Acceptability questionnaire (designed specifically for this study)
Timepoint [5] 314054 0
Post treatment
Secondary outcome [6] 314055 0
General Self-Efficacy Scale (GSES)
Timepoint [6] 314055 0
Baseline
Secondary outcome [7] 314056 0
Reason for Compulsion Questionnaire (designed specifically for this study)
Timepoint [7] 314056 0
Baseline
Secondary outcome [8] 314057 0
Type of obsession questionnaire (designed specifically for this study)
Timepoint [8] 314057 0
Baseline
Secondary outcome [9] 314058 0
The Disgust Scale – Revised
Timepoint [9] 314058 0
Baseline
Secondary outcome [10] 314059 0
The Readiness Ruler (RR)
Timepoint [10] 314059 0
Baseline
Secondary outcome [11] 314060 0
Difficulties in Emotion Regulation Scale
Timepoint [11] 314060 0
Baseline

Eligibility
Key inclusion criteria
(1) English speaking;
(2) 18 years of age and above;
(3) Have regular access to the Internet;
(4) No suicidal plans or intention, or recent history of suicide attempts or deliberate self-harm, or severe depression (a score of 20 or greater on the PHQ9).
(5) No history of psychotic illnesses or bipolar disorder
(6) Score at least a 7 on one of the subscales on the Dimensional Obsessive Compulsive Scale (DOCS).
(7) Score at least 14 on the YBOCS
(8) Provides informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Currently drinking or using illicit drugs on a daily basis

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 will be recruited from Australia and internationally via the eCentreClinic website until the 600 participants are recruited. Potential applicants will read about the study and will be invited to apply. Those interested will read more information and will then complete an online Informed Consent Form. Applicants who do not meet study criteria will be automatically excluded with clear information provided encouraging them to seek support from their primary care provider. All excluded participants will also be provided with the details of an international organization that assists with finding local crisis services (www.befrienders.org). Eligible participants will be sent an email welcoming them to the Course and given details about how to access the Course.

The website www.random.org will be used to determine a list of randomly generated numbers that correspond to a group. Participants will be randomly allocated to one of the two groups after they successfully complete the application process. The process is unblinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The website www.random.org will be used to determine a list of randomly generated numbers that correspond to a group. Participants will be randomly allocated to one of the two groups after they successfully complete the application process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A CONSORT-R compliant RCT comparing 2 parallel groups.

Patients will be randomly allocated to one of the two groups (total n=600). Randomization will be completed via www.random.org.

1. Waitlist control, Group 1 (n=300). This group will receive the self-guided Internet education once the other group has completed the program (week 9).

2. Internet self-guided, Group 2 (n=300). This group will receive immediate access to the self-guided Internet program.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6806 0
New Zealand
State/province [1] 6806 0
All
Country [2] 6807 0
Canada
State/province [2] 6807 0
All
Country [3] 6808 0
United States of America
State/province [3] 6808 0
All
Country [4] 6809 0
United Kingdom
State/province [4] 6809 0
All

Funding & Sponsors
Funding source category [1] 291087 0
University
Name [1] 291087 0
University of Tasmania School of Medicine Small Grant
Address [1] 291087 0
School of Medicine (Psychology). PO Box 30. Hobart. 7000. TAS
Country [1] 291087 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road. North Ryde, NSW 2109.
Country
Australia
Secondary sponsor category [1] 289767 0
University
Name [1] 289767 0
University of Tasmania
Address [1] 289767 0
School of Medicine (Psychology). PO Box 30. Hobart. 7000. TAS
Country [1] 289767 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292670 0
Macquarie University HREC
Ethics committee address [1] 292670 0
Balaclava Road. North Ryde. NSW 2109.
Ethics committee country [1] 292670 0
Australia
Date submitted for ethics approval [1] 292670 0
Approval date [1] 292670 0
18/05/2015
Ethics approval number [1] 292670 0
5201300629

Summary
Brief summary
The aim of this study is to recruit and educate participants with obsessive-compulsive disorder using a 5-lesson education program administered via the Internet. Participants in the Internet self-guided group begin the program immediately, and their results will be compared with a waitlist control condition. To understand who responds best to a self-guided education, participants will complete various measures assessing variables such as self-efficacy, reason for compulsion, type of obsession, level of disgust, readiness to change and emotion regulation deficits. Participants in Group 2 will receive access to the education program when Group 1 completes post-education assessments (Week 9). Both groups will be followed up at 3-,12-, and 24-months post-education.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes
We are recruiting from all countries. The participant is only required to speak English.

Contacts
Principal investigator
Name 43662 0
Dr Blake Dear
Address 43662 0
Department of Psychology.
Macquarie University
North Ryde. NSW 2109
Country 43662 0
Australia
Phone 43662 0
+61 2 9850 9979
Fax 43662 0
Email 43662 0
blake.dear@mq.edu.au
Contact person for public queries
Name 43663 0
Dr Bethany Wootton
Address 43663 0
School of Psychology
Department of Behavioural, Cognitive and Social Sciences
University of New England
Armidale
NSW 2350
Country 43663 0
Australia
Phone 43663 0
+61 2 6773 5798
Fax 43663 0
Email 43663 0
bwootton@une.edu.au
Contact person for scientific queries
Name 43664 0
Dr Bethany Wootton
Address 43664 0
School of Psychology
Department of Behavioural, Cognitive and Social Sciences
University of New England
Armidale
NSW 2350
Country 43664 0
Australia
Phone 43664 0
+61 2 6773 5798
Fax 43664 0
Email 43664 0
bwootton@une.edu.au