Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000989842
Ethics application status
Approved
Date submitted
23/06/2021
Date registered
28/07/2021
Date last updated
28/07/2021
Date data sharing statement initially provided
28/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of an Online Cognitive Behaviour Therapy Program on Death Anxiety in a Community Sample
Scientific title
Effects of an Online CBT Program on Death Anxiety in a Community Sample
Secondary ID [1] 304246 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Death anxiety 321948 0
Condition category
Condition code
Mental Health 319679 319679 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Overcome Death Anxiety program consists of 7 online modules, all of which are based on the principles of Cognitive Behavior Therapy (CBT). Across the 7 modules, participants will be given psychoeducation about the relationship between thoughts and emotion and will be shown how to challenge unhelpful thoughts related to their own specific fears about death. The role of avoidance in maintaining anxiety will also be explained, with modules incorporating specific individualised exposure tasks. Tasks to increase the participant’s sense of meaning in life will also be included. Information regarding relapse prevention will also be provided. Much of the content has been designed specifically for this study, and is not based on a freely available resource. All modules are based on well-evaluated standard CBT approaches to anxiety.

The online program can be completed at the participant’s own pace, and from any computer. While the completion time will vary for each participant, the online modules are expected to take an average of 9 hours in total to complete. These modules can be completed across multiple sessions or days, at the participant’s convenience. Participants will have up to 5 months from commencement to access the modules.

Elements of the program are personalised for participants. For instance, the answers to survey questions at the beginning of the program are used by the software to select homework assignments for participants, such as specific exposure tasks (e.g., watching a film about death, talking to a loved one about death) based on their earlier responses.

Adherence will be assessed by number of modules completed. Number of log-ins and time spent on the program will also be assessed. The primary strategy employed to reduce attrition will be automated email reminders. As well as receiving emails congratulating participants for completing each module, they will also receive reminders if they have not logged on to the program for 3, 7, 10,14, 21 or 28 days. If they still do not respond, they will not be contacted further until the end of the program, at which point attempts to contact them will be made in order to gain end-of-treatment data.
Intervention code [1] 320579 0
Treatment: Other
Intervention code [2] 320580 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327561 0
Death anxiety, as measured by the Collett Lester Fear of Death Scale-Revised
Timepoint [1] 327561 0
Measured at baseline and immediately post-treatment
Secondary outcome [1] 395661 0
Multidimensional Fear of Death Scale score
Timepoint [1] 395661 0
Measured at baseline and immediately post-intervention
Secondary outcome [2] 397263 0
DASS-21 Depression Score
Timepoint [2] 397263 0
Measured at baseline and immediately post-intervention
Secondary outcome [3] 398123 0
DASS-21 Anxiety score
Timepoint [3] 398123 0
Measured at baseline and immediately post-intervention
Secondary outcome [4] 398124 0
DASS-21 Stress score
Timepoint [4] 398124 0
Measured at baseline and immediately post-intervention

Eligibility
Key inclusion criteria
Inclusion criteria are (1) adults over the age of 18 years, (2) access to regular internet/email, (3) functional written and spoken English, (4) high in death anxiety on the Multidimensional Fear of Death Scale (Hoelter, 1979; lower than the community mean, representing higher than average death anxiety).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include (1) currently undergoing alternative psychological treatment targeting death related fears, (2) Severe depression or suicidality as indicated by a response of 2 or more on item 9 of the PHQ-9.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/04/2021
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
3/01/2022
Actual
Sample size
Target
75
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308624 0
Self funded/Unfunded
Name [1] 308624 0
Unfunded
Country [1] 308624 0
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 309496 0
None
Name [1] 309496 0
Address [1] 309496 0
Country [1] 309496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308554 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 308554 0
University of Technology Sydney, 15 Broadway, Ultimo NSW 2007
Ethics committee country [1] 308554 0
Australia
Date submitted for ethics approval [1] 308554 0
Approval date [1] 308554 0
02/03/2021
Ethics approval number [1] 308554 0

Summary
Brief summary
The current trial aims to assess the efficacy of a new online psychological treatment for fears of death. Outcomes include death anxiety, depression, anxiety, and stress scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111118 0
Prof Ross Menzies
Address 111118 0
Room 01.13.033 Building 1 University of Technology Sydney. 15 Broadway Ultimo Sydney NSW 2007
Country 111118 0
Australia
Phone 111118 0
+61 02 95145314
Fax 111118 0
Email 111118 0
[email protected]
Contact person for public queries
Name 111119 0
Dr Rachel Menzies
Address 111119 0
Room 423 Brennan Maccallum Building, University of Sydney Camperdown NSW 2006
Country 111119 0
Australia
Phone 111119 0
+61 02 91140943
Fax 111119 0
Email 111119 0
[email protected]
Contact person for scientific queries
Name 111120 0
Dr Rachel Menzies
Address 111120 0
Room 423 Brennan Maccallum Building, University of Sydney Camperdown NSW 2006
Country 111120 0
Australia
Phone 111120 0
+61 02 91140943
Fax 111120 0
Email 111120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data on which a report was published will be shared.
When will data be available (start and end dates)?
Data will be available from the date of publication of such a report, until the next 7 years.
Available to whom?
Data will be available to other researchers upon request
Available for what types of analyses?
Data will be available for replication of the report's analyses and/or novel analyses to explore potential alternative explanations based on the data.
How or where can data be obtained?
Data will be made available to other researchers electronically (through email via [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11698Study protocol  [email protected]
11699Statistical analysis plan  [email protected]
11700Informed consent form  [email protected]
11701Clinical study report  [email protected]
11702Ethical approval  [email protected]
11703Analytic code  [email protected]



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.