ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

obsessive compulsive disorder

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

Yale Brown Obsessive Compulsive Disorder Scale (YBOCS)

Timepoint [1]

Baseline
Weekly through treatment
Post-education (week 8)
3-month follow up
12 month follow up
24 month follow up

Secondary outcome [1]

Dimensional Obsessive Compulsive Scale

Timepoint [1]

Baseline
Mid treatment (Week 5)
Post-treatment (week 10)
3 month follow up
12 month follow up
24 month follow up

Secondary outcome [2]

Patient Health Questionnaire-9 Item (PHQ-9)

Timepoint [2]

Baseline
Weekly through treatment
Post-education (week 8)
3-month follow up
12 month follow up
24 month follow up

Secondary outcome [3]

Self-report Clinical Global Impression (CGI) (severity and improvement)

Timepoint [3]

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]

Adherence questionnaire (designed specifically for this study)

Timepoint [4]

Weekly through treatment

Secondary outcome [5]

Acceptability questionnaire (designed specifically for this study)

Timepoint [5]

Post treatment

Secondary outcome [6]

General Self-Efficacy Scale (GSES)

Timepoint [6]

Baseline

Secondary outcome [7]

Reason for Compulsion Questionnaire (designed specifically for this study)

Timepoint [7]

Baseline

Secondary outcome [8]

Type of obsession questionnaire (designed specifically for this study)

Timepoint [8]

Baseline

Secondary outcome [9]

The Disgust Scale – Revised

Timepoint [9]

Baseline

Secondary outcome [10]

The Readiness Ruler (RR)

Timepoint [10]

Baseline

Secondary outcome [11]

Difficulties in Emotion Regulation Scale

Timepoint [11]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/06/2015

Actual

1/08/2015

Date of last participant enrolment

Anticipated

Actual

17/07/2017

Date of last data collection

Anticipated

30/12/2019

Actual

Sample size

Target

600

Accrual to date

Final

190

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

All

Country [2]

Canada

State/province [2]

All

Country [3]

United States of America

State/province [3]

All

Country [4]

United Kingdom

State/province [4]

All

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Tasmania School of Medicine Small Grant

Address [1]

School of Medicine (Psychology). PO Box 30. Hobart. 7000. TAS

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Road. North Ryde, NSW 2109.

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Tasmania

Address [1]

School of Medicine (Psychology). PO Box 30. Hobart. 7000. TAS

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University HREC

Ethics committee address [1]

Balaclava Road. North Ryde. NSW 2109.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/05/2015

Ethics approval number [1]

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

Dr Blake Dear

Address

Department of Psychology.
Macquarie University
North Ryde. NSW 2109

Country

Australia

Phone

+61 2 9850 9979

Fax

[email protected]

Contact person for public queries

Name

Bethany Wootton

Address

School of Psychology
Department of Behavioural, Cognitive and Social Sciences
University of New England
Armidale
NSW 2350

Country

Australia

Phone

+61 2 6773 5798

Fax

[email protected]

Contact person for scientific queries

Name

Bethany Wootton

Address

School of Psychology
Department of Behavioural, Cognitive and Social Sciences
University of New England
Armidale
NSW 2350

Country

Australia

Phone

+61 2 6773 5798

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Self-guided internet-delivered cognitive behavior therapy (ICBT) for obsessive-compulsive symptoms: A randomized controlled trial.	2019	https://dx.doi.org/10.1016/j.janxdis.2019.102111

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically