Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001052921
Ethics application status
Not yet submitted
Date submitted
4/10/2011
Date registered
7/10/2011
Date last updated
7/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Development, evaluation and implementation of an online metacognitive intervention programme for Obsessive-Compulsive Disorder
Scientific title
In Adults with symptoms of Obsessive-Compulsive Disorder (OCD), is online self-help metacognitive therapy more effective than progressive muscle relaxation training in reducing symptoms of OCD?
Secondary ID [1] 273157 0
Nil
Universal Trial Number (UTN)
U1111-1125-0090
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder symptoms 278908 0
depression symptoms 278909 0
anxiety symptoms 278910 0
Condition category
Condition code
Mental Health 279087 279087 0 0
Anxiety
Mental Health 279093 279093 0 0
Depression
Mental Health 279094 279094 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If participants are randomly allocated to the intervention group, treatment will be based on the manual Individual and Group Metacognitive Therapy for Obsessive Compulsive Disorder (Rees & van Koesveld, 2009). This manual will be reviewed and modified in study 1 (development of the programme and website) in order to be used as an online self-help programme. The programme will be provided through the website 'the OCD-Doctor-Online'. A time period of six weeks will be allocated to all participants to complete the program (a total of 10 modules). At the end of each module, a number of questions will be asked to ensure that participants completely understand the content of that module. It is anticipated that each module will take approximately 1 hour to complete. In order to ensure that participants complete modules in the correct order, modules will not be available until questions from the previous modules have been completed.
Intervention code [1] 269491 0
Treatment: Other
Intervention code [2] 269495 0
Behaviour
Comparator / control treatment
If participants are randomly allocated to the control group, progressive muscle relaxation training will be administered online. Progressive muscle relaxation training has been successfully used in controlled trials as a credible comparison condition (e.g. Fals-Stewart, Marks, & Schafer, 1993; Twohig et al., 2010).
Participants will be provided with audio exercises weekly (15-30 minutes) for 6 weeks to teach them specific progressive muscle relaxation techniques. They will also be allocated homework to practice these exercises a minimum of once a day (15 minutes - 30 minutes).

After study 2 (implementation and evaluation of the program) is complete, participants in the control group will be provided with access to the online MCT programme if they wish.
Control group
Active

Outcomes
Primary outcome [1] 279728 0
Obsessive-compulsive Inventory - Revised (OCI-R). The 18-item self-report questionnaire assesses several symptoms of OCD. Items on the self-report questionnaire refer to experiences that many people may have in their everyday lives. The scales assesses how much each of these items have distressed or bothered the participant in the past month.
Timepoint [1] 279728 0
Pre-test, following the completion of each module, Post-test (immediately following the intervention), 6-week follow-up
Secondary outcome [1] 294316 0
Yale-Brown Obsessive-Compulsive Symptom Checklist. Is used to indicate whether or not the individual has specific types of obsessions or compulsions. It will be used to determine if particular obsessions or compulsions, or both, have reduced following treatment.
Timepoint [1] 294316 0
Pre-test, Post-test (immediately following the intervention), 6-week follow-up
Secondary outcome [2] 294317 0
Depression, Anxiety, Stress Scales - 21 (DASS-21). The 21-item self-report questionnaire is used as a quantitative measure or symptoms relevant to depression, anxiety and stress.
Timepoint [2] 294317 0
Pre-test, Following the completion of each module, Post-test (immediately following the intervention), 6-week follow-up.
Secondary outcome [3] 294318 0
Metacognitions Questionnaire - 30 (MCQ-30). The MCQ-30 evaluates the role that metacognitions play in clinical diagnoses and may also be used as part of metacognitive therapy. A high score on the MCQ-30 indicates that the participant has a stronger belief about hte importance of control, as well as the negative consequences associated with intrusive or unwanted thoughts.
Timepoint [3] 294318 0
Pre-test, Post-test (immediately following the intervention), 6-week follow-up
Secondary outcome [4] 294319 0
Quality of Life enjoyment and satisfaction questionnaire - 18 (Q-LES-Q-18). The self-report scale measures general quality of life and specific life domain levels of enjoyment and satisfaction. The specific life domains include: physical health, subjective feelings, leisure time activity, social relationships, and satisfaction with medication.
Timepoint [4] 294319 0
Pre-test, Post-test (immediately following the intervention), 6-week follow-up
Secondary outcome [5] 294320 0
Psychiatric diagnostic Screening Questionnaire (PDSQ). A brief self-report scale consisting of 126 items which are designed to screen for symptoms of 13 different DSM-IV-TR Axis I disorders.
Timepoint [5] 294320 0
Pre-test, Post-test (immediately following the intervention), 6-week follow-up
Secondary outcome [6] 294321 0
Suicidality section of the Mini International Neuropsychiatric Interview (MINI). The suicidality section of the MINI classifies participants into four groups: no suicidal risk, low suicidal risk, moderate suicidal risk, and high suicidal risk.
Timepoint [6] 294321 0
Pre-test (to screen for suicidal risk), Weekly, Post-test (Immediately following the intervention), 6-week follow-up.

Eligibility
Key inclusion criteria
- Have a total score on the OCI-R of 21 or greater, as defined by Foa and colleagues (2002) as the optimal cut-off to distinguish OCD clients from non-anxious clients.
- Be aged 18 years or over.
- If participants are taking medication such as antidepressants or other mood stabilisers, they must be stable on this medication one month prior to their baseline assessment.
- Participants must be willing to remain on the same dosage of the same medication throughout the entire treatment period including follow-up.
- Be currently living in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- They show moderate to high suicidal risk as measured by the suicidality section of the MINI (Sheehan et al., 1997).
- They meet the diagnosis for psychosis and/or schizophrenia, according to the DSMIV-TR diagnostic criteria, as measured by the PDSQ (Zimmerman & Mattia, 2001a, 2001b).
- They are currently undergoing other psychological treatment.

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)
A number of inclusion and exclusion criteria apply. Once participants have gone through the screening process and are found to be eligible to participate in the research study, they will be randomly allocated to either intervention or control group. Random allocation will be conducted by computer generated software (Saghaei’s [2004] Random Allocation computer software version 1.0). All measures are self-administered online. The researchers will therefore have no knowledge of the condition to which the participant will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the sequence in which subjects will be randomised will be a simple random allocation procedure. The researcher will use Saghaei’s (2004) Random Allocation computer software version 1.0 to generate randomised number lists. The researcher will correspond with a statistician from Curtin University of Technology to ensure equal group sizes. Correspondence with a professional programmer will help to incorporate the randomisation software into the website to randomly allocate participants to groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269972 0
University
Name [1] 269972 0
Curtin University of Technology
Country [1] 269972 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Clare Rees, Principal Investigator of the study
Address
School of Psychology, Curtin University of Technology,
Kent Street, Bentley, Perth,
Western Australia, 6102.
Country
Australia
Secondary sponsor category [1] 268965 0
None
Name [1] 268965 0
N/A
Address [1] 268965 0
N/A
Country [1] 268965 0
Other collaborator category [1] 252278 0
Individual
Name [1] 252278 0
Dr Sarah Egan
Address [1] 252278 0
School of Psychology, Curtin University of Technology,
Kent Street, Bentley, Perth,
Western Australia, 6102.
Country [1] 252278 0
Australia
Other collaborator category [2] 252279 0
Individual
Name [2] 252279 0
Miss Caitlin Pearcy
Address [2] 252279 0
School of Psychology, Curtin University of Technology,
Kent Street, Bentley, Perth,
Western Australia, 6102.
Country [2] 252279 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271936 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 271936 0
Ethics committee country [1] 271936 0
Australia
Date submitted for ethics approval [1] 271936 0
26/09/2011
Approval date [1] 271936 0
Ethics approval number [1] 271936 0

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

Contacts
Principal investigator
Name 33231 0
Address 33231 0
Country 33231 0
Phone 33231 0
Fax 33231 0
Email 33231 0
Contact person for public queries
Name 16478 0
Miss Caitlin Pearcy
Address 16478 0
Curtin University of Technology
School of psychology and speech pathology,
Kent Street, Bentley,
Western Australia, 6102
Country 16478 0
Australia
Phone 16478 0
+61 431 914 116
Fax 16478 0
N/A
Email 16478 0
[email protected]
Contact person for scientific queries
Name 7406 0
Associate Professor Clare Rees
Address 7406 0
Curtin University of Technology
School of psychology and speech pathology,
Kent Street, Bentley,
Western Australia, 6102
Country 7406 0
Australia
Phone 7406 0
+61 8 9266 3442
Fax 7406 0
+61 8 9266 2464
Email 7406 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
No additional documents have been identified.