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Trial registered on ANZCTR


Registration number
ACTRN12619000384156p
Ethics application status
Submitted, not yet approved
Date submitted
25/02/2019
Date registered
12/03/2019
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of an Online Cognitive Behaviour Therapy Intervention for Death Anxiety
Scientific title
A Phase I Trial of an Online CBT Treatment Program for Death Anxiety in adults with a mental health condition
Secondary ID [1] 297275 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Death anxiety 311352 0
Condition category
Condition code
Mental Health 309985 309985 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This Phase I trial is designed to assess the efficacy, safety, and feasibility of a novel online treatment for death anxiety. The Overcoming 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] 313528 0
Treatment: Other
Intervention code [2] 313529 0
Behaviour
Comparator / control treatment
No control group (Phase I trial)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318902 0
Proportion of participants who significantly benefit, as measured by a Reliable Change Index score on the Revised Collett-Lester Fear of Death Scale.
Timepoint [1] 318902 0
Measured at baseline and post-treatment
Secondary outcome [1] 366370 0
Mean satisfaction score on item "Overall, how satisfied were you with the program?" (rated from 0-10)
Timepoint [1] 366370 0
Measured post-intervention
Secondary outcome [2] 366965 0
Proportion of participants who experience an adverse event
Timepoint [2] 366965 0
Assessed using the weekly completion of the Patient Health Questionnaire-9 (PHQ-9), up to 5 months after commencement

Eligibility
Key inclusion criteria
Inclusion criteria:
(1) adults with a diagnosed mental health condition,
(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; 1 standard deviation lower than the community mean, representing significantly higher than average death anxiety).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
(1) having undergone CBT treatment in the last 6 months, and
(2) currently experiencing a psychotic mental illness
(3) currently reporting severe symptoms of depression (defined as a total score of >19 or responding >1 to Question Nine (suicidal ideation) on 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)
Allocation is not concealed. Participants will be adults on a treatment waitlist at a local psychological practice in Sydney, who will be invited to participate in the study. If they consent to discussing study participation further, the researcher's contact details will be made available to them, in order to commence eligibility screening.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
NSW

Funding & Sponsors
Funding source category [1] 301834 0
Self funded/Unfunded
Name [1] 301834 0
Unfunded
Address [1] 301834 0
NA
Country [1] 301834 0
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 301759 0
None
Name [1] 301759 0
Address [1] 301759 0
Country [1] 301759 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302535 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 302535 0
Level 3, Administration Building (F23), University of Sydney NSW 2006, Australia
Ethics committee country [1] 302535 0
Australia
Date submitted for ethics approval [1] 302535 0
04/02/2019
Approval date [1] 302535 0
Ethics approval number [1] 302535 0

Summary
Brief summary
The current study aims to assess the efficacy, safety, and usability (i.e., clarity, efficiency, ease of navigation) of a new online psychological treatment for fears of death. We expect that this new treatment will result in reductions in fears of death and few adverse events, and will be seen seen as helpful and easy to use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90558 0
Dr Ilan Dar-Nimrod
Address 90558 0
Room 420, Brennan MacCallum Building, A18, The University of Sydney NSW 2006 Australia.
Country 90558 0
Australia
Phone 90558 0
+61 293512908
Fax 90558 0
Email 90558 0
ilan.dar-nimrod@sydney.edu.au
Contact person for public queries
Name 90559 0
Ms Rachel Menzies
Address 90559 0
Room 464, Griffith Taylor Building, The University of Sydney NSW 2006 Australia.
Country 90559 0
Australia
Phone 90559 0
+61 293512908
Fax 90559 0
Email 90559 0
rmen9233@uni.sydney.edu.au
Contact person for scientific queries
Name 90560 0
Ms Rachel Menzies
Address 90560 0
Room 464, Griffith Taylor Building, The University of Sydney NSW 2006 Australia.
Country 90560 0
Australia
Phone 90560 0
+61 293512908
Fax 90560 0
Email 90560 0
rmen9233@uni.sydney.edu.au

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)
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Analytic code
Summary results
No Results