Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000419864
Ethics application status
Approved
Date submitted
18/02/2021
Date registered
15/04/2021
Date last updated
25/03/2022
Date data sharing statement initially provided
15/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effectiveness of two online interventions for sub-threshold and mild obsessive-compulsive symptoms: a randomised controlled trial
Scientific title
The OCEAN Study: a randomised controlled trial comparing the effect of online acceptance and commitment therapy and progressive relaxation on symptom severity and psychological flexibility in sub-threshold and mild obsessive-compulsive symptoms.
Secondary ID [1] 303491 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-compulsive symptoms 320810 0
Depressive symptoms 320811 0
Anxiety symptoms 320812 0
Condition category
Condition code
Mental Health 318632 318632 0 0
Anxiety
Mental Health 318633 318633 0 0
Depression
Mental Health 318634 318634 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online Acceptance and Commitment Therapy (ACT) program called YOLO (You Only Live Once; Viskovich & Packenham, 2019). The program involves 4 modules that target the ACT processes: acceptance, defusing from thoughts, mindfulness and
observer self, and values and committed action. Participants are given 6 weeks to complete the modules in their own home and on a device that has an internet connection. Each module is 30-50 minutes in length, however consists of several small exercises of 5-10 minutes each, including animated presentations, you-tube clips, audio files and written exercises that are based on ACT. The intervention is not personalised to participants. Participants receive automated email reminders every 2-8 days to prompt engagement over the 6-week active intervention period. A standard automated email will be sent after a participant has completed a module, providing a recap of the module and skills to practice during the week. Adherence to the modules and the exercises within them will be monitored by the student researcher by accessing website analytics.
Intervention code [1] 319781 0
Behaviour
Intervention code [2] 320044 0
Treatment: Other
Comparator / control treatment
An active control will be used, namely an online Progressive Relaxation Training (PRT) program called STRESS-LESS. The program is an abbreviated and online version of Bernstein and colleagues’ (2000) protocol, and involves 4 modules of the same format, duration, and interactivity as the intervention condition. The modules teach participants how to tense and relax specific muscle groups while paying attention to the sensations in their bodies associated with relaxation and tension. Over the four modules, participants will learn how to achieve relaxation in a shorter amount of time by using larger muscle groups and the techniques of recall and counting. Participants receive automated email reminders every 2-8 days to prompt engagement over the 6-week active intervention period. A standard automated email will be sent after a participant has completed a module, providing a recap of the module and skills to practice during the week. Adherence to the exercises within the modules will be monitored by the student researcher by accessing completion data (% exercise completed) on the Qualtrics platform.
Control group
Active

Outcomes
Primary outcome [1] 326588 0
Change in psychological flexibility sub scores, as measured by the Multidimensional Psychological Flexibility Inventory
Timepoint [1] 326588 0
6 weeks after baseline (primary timepoint). Follow-up timepoint changed to 18 weeks after baseline.
Primary outcome [2] 326589 0
Change in psychological inflexibility sub scores, as measured by the Multidimensional Psychological Flexibility Inventory
Timepoint [2] 326589 0
6 weeks after baseline (primary timepoints). Follow-up timepoint changed to 18 weeks after baseline.
Primary outcome [3] 326590 0
Change in obsessive-compulsive symptoms, as measured by the Dimensional Obsessive-Compulsive Scale
Timepoint [3] 326590 0
6 weeks after baseline (primary timepoints). Follow-up timepoint changed to 18 weeks after baseline.
Secondary outcome [1] 392010 0
Change in depression scores, as measured by the Depression, Anxiety and Stress Scale -21 (DASS-21)
Timepoint [1] 392010 0
6 weeks after baseline (primary timepoints), and follow-up timepoint changed to 18 weeks after baseline.
Secondary outcome [2] 392011 0
Change in anxiety scores, as measured by the Depression, Anxiety and Stress Scale -21 (DASS-21)
Timepoint [2] 392011 0
6 weeks after baseline (primary timepoints), and follow-up timepoint changed to 18 weeks after baseline.
Secondary outcome [3] 392012 0
Change in quality of life scores, as measure by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Timepoint [3] 392012 0
6 weeks after baseline (primary timepoints), and follow-up timepoint changed to 18 weeks after baseline.
Secondary outcome [4] 392013 0
Self-reported adherence to the intervention, as measured by how many days participants self-reported practicing between modules
Timepoint [4] 392013 0
On completion of each module (4 possible time-points), and 6 weeks and 18 weeks after baseline.
Secondary outcome [5] 392015 0
Adherence to intervention, as measured by the percentage of interevention completed. Such information will be attained by accessing website analytics and module completion data in Qualtrics.
Timepoint [5] 392015 0
6 weeks after baseline.
Secondary outcome [6] 392016 0
Program satisfaction assessed by individually rated items (from 1-5) on a custom built survey, including ratings of (1) satisfaction with the program, (2) relevance of content, (3) helpfulness of the emails, (4) and how likely they would be to recommend the program.
Timepoint [6] 392016 0
6 weeks after baseline
Secondary outcome [7] 392017 0
Program usability, measured by the System Usability Scale.
Timepoint [7] 392017 0
6 weeks after baseline
Secondary outcome [8] 392018 0
Adverse experiences, measured as percent yes or no, and if yes, a qualitative description.
Timepoint [8] 392018 0
After each module completion (4 possible time-points)

Eligibility
Key inclusion criteria
Participants will a) endorse sub-clinical or mild obsessive-compulsive symptoms, as define by Dimensional Obsessive-Compulsive Scale (DOCS) scores >11 and <32, and b) be fluent in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will be used to screen out severe presentations that potentially need more intensive or disorder-specific interventions, or to control for confounding impact of parallel treatment changes: (a) a history of psychotic symptoms (b) acute suicidal tendencies, (c) or have begun or modified psychiatric or psychological treatment within 8 weeks of beginning the study,

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)
Participant allocation will involve contacting the holder of the allocation schedule who is "off-site" and not involved in the research study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Stratified allocation is also used based on 4 factors; gender, severity of obsessive-compulsive symptoms, severity of stress, and severity of anxiety.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2021
Actual
21/04/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
100
Accrual to date
85
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23471 0
United Kingdom
State/province [1] 23471 0
Country [2] 23472 0
United States of America
State/province [2] 23472 0
Country [3] 23473 0
New Zealand
State/province [3] 23473 0
Country [4] 23474 0
Canada
State/province [4] 23474 0
Country [5] 23475 0
Ireland
State/province [5] 23475 0

Funding & Sponsors
Funding source category [1] 307909 0
University
Name [1] 307909 0
Monash University
Country [1] 307909 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Turner Institute for Brain and Mental Health,
Monash University,
770 Blackburn Road,
Clayton, VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 308623 0
None
Name [1] 308623 0
Address [1] 308623 0
Country [1] 308623 0
Other collaborator category [1] 281656 0
University
Name [1] 281656 0
University of Queensland
Address [1] 281656 0
Brisbane
St Lucia, QLD 4072
Australia
Country [1] 281656 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307907 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 307907 0
Ethics committee country [1] 307907 0
Australia
Date submitted for ethics approval [1] 307907 0
19/02/2020
Approval date [1] 307907 0
15/04/2020
Ethics approval number [1] 307907 0
22724

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

Contacts
Principal investigator
Name 108890 0
Prof Leondardo Fontenelle
Address 108890 0
Monash University
770 Blackburn Road
Clayton VIC 3800 Australia
Country 108890 0
Australia
Phone 108890 0
+61 3 9902 9755
Fax 108890 0
Email 108890 0
[email protected]
Contact person for public queries
Name 108891 0
Leondardo Fontenelle
Address 108891 0
Monash University
770 Blackburn Road
Clayton VIC 3800 Australia
Country 108891 0
Australia
Phone 108891 0
+61 3 9902 9755
Fax 108891 0
Email 108891 0
[email protected]
Contact person for scientific queries
Name 108892 0
Leondardo Fontenelle
Address 108892 0
Monash University
770 Blackburn Road
Clayton VIC 3800 Australia
Country 108892 0
Australia
Phone 108892 0
+61 3 9902 9755
Fax 108892 0
Email 108892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As Monash has signed a research agreement with University of Queensland, the data will not be shared in order to refrain from infringing upon the project intellectual property.


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.