ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000384156

Ethics application status

Approved

Date submitted

25/02/2019

Date registered

12/03/2019

Date last updated

16/12/2020

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Death anxiety

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

No control group (Phase I trial)

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Measured at baseline and post-treatment

Secondary outcome [1]

Mean satisfaction score on item "Overall, how satisfied were you with the program?" (rated from 0-10)

Timepoint [1]

Measured post-intervention

Secondary outcome [2]

Proportion of participants who experience an adverse event

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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)

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

Recruiting

Date of first participant enrolment

Anticipated

4/06/2019

Actual

20/05/2020

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]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

Country [1]

Primary sponsor type

University

Name

University of Sydney

Address

The University of Sydney, NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Level 3, Administration Building (F23), University of Sydney NSW 2006, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/02/2019

Approval date [1]

15/11/2019

Ethics approval number [1]

2019/171

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

Dr Ilan Dar-Nimrod

Address

Room 420, Brennan MacCallum Building, A18, The University of Sydney NSW 2006 Australia.

Country

Australia

Phone

+61 293512908

Fax

[email protected]

Contact person for public queries

Name

Rachel Menzies

Address

Room 464, Griffith Taylor Building, The University of Sydney NSW 2006 Australia.

Country

Australia

Phone

+61 293512908

Fax

[email protected]

Contact person for scientific queries

Name

Rachel Menzies

Address

Room 464, Griffith Taylor Building, The University of Sydney NSW 2006 Australia.

Country

Australia

Phone

+61 293512908

Fax

[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)

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23725	Ethical approval			[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.

Trial Review

Documents added manually

Documents added automatically