Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000544673p
Ethics application status
Submitted, not yet approved
Date submitted
6/04/2023
Date registered
22/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
22/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Cognitive Behavioural Therapy for Death Anxiety: A Randomised Controlled Trial
Scientific title
Efficacy of an Online Cognitive Behavioural Therapy Intervention for Treatment of Death Anxiety in Adults With Mental Illness: A Randomised Controlled Trial
Secondary ID [1] 309335 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Death Anxiety 329535 0
Condition category
Condition code
Mental Health 326469 326469 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is designed to assess the efficacy of a novel online treatment for death anxiety compared to a waitlist control. The Overcome Death Anxiety program consists of 7 online modules, all of which are based on the principles of Cognitive Behaviour Therapy (CBT). Across the 7 modules, participants will begiven 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. The ODA program is standalone, automated, and individualised. Participants will have up to 5 months from commencement to access the modules. Although the duration of each module varies, the program is expected take approximately 10 hours in total to complete. The modules consist of a variety of materials including some pre-recorded videos, interactive written exercises and quizzes, and reflection tasks.
Intervention code [1] 325769 0
Treatment: Other
Intervention code [2] 325770 0
Behaviour
Comparator / control treatment
Participants in the waitlist control group will each be yoked to participants in the treatment group. Participants in the control group will complete the same pre-treatment questionnaires as the treatment group (excluding those assessing treatment expectancy). Once a participant in the treatment group completes the program, the corresponding control participant will be prompted to complete the post-treatment questionnaires (excluding those assessing treatment evaluation). They will then have the opportunity to complete the program themselves.
Control group
Active

Outcomes
Primary outcome [1] 334314 0
Difference in death anxiety post-intervention compared to pre-intervention, measured using the Death Anxiety Beliefs and Behaviours Scale (DABBS)
Timepoint [1] 334314 0
Measured at baseline and immediately post-treatment
Primary outcome [2] 334812 0
Difference in death anxiety post-intervention compared to pre-intervention, measured using the Collett Lester Fear of Death Scale Revised (CLFD-R)
Timepoint [2] 334812 0
Measured at baseline and immediately post-treatment
Secondary outcome [1] 420226 0
Stress scores on the Depression Anxiety and Stress Scale (DASS-21)
Timepoint [1] 420226 0
Measured immediately post-treatment
Secondary outcome [2] 420227 0
Mean scores on the Suicidality Scale
Timepoint [2] 420227 0
Measured immediately post-treatment
Secondary outcome [3] 420228 0
Mean scores on the Meaning in Life Questionnaire
Timepoint [3] 420228 0
Measured immediately post-treatment
Secondary outcome [4] 420229 0
Treatment satisfaction, measured using mean scores on a post-treatment evaluation questionnaire
Timepoint [4] 420229 0
Measured immediately at post-treatment
Secondary outcome [5] 422143 0
Depression, measured by the Depression subscale of the Depression Anxiety Stress Scales DASS-21
Timepoint [5] 422143 0
Measured immediately post-treatment
Secondary outcome [6] 422144 0
Anxiety, measured by the Anxiety subscale of the Depression Anxiety Stress Scales (DASS-21)
Timepoint [6] 422144 0
Measured immediately post-treatment

Eligibility
Key inclusion criteria
1) More than 18 years old
2) Diagnosed anxiety-related disorder, assessed using a structured diagnostic interview (the Anxiety and Related Disorders Interview Schedule: Lifetime Edition
3) Access to regular internet/email
4) Currently live in Australia
5) Functional written and spoken English
6) High in death anxiety on the Death Anxiety Beliefs and Behaviours Scale (DABBS; i.e. above the clinical cutoff of 55)
7) If taking anti-depressant medication, have been on a stable dose for more than 8 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Endorsing frequent thoughts of suicide on the PHQ-9
2) Having received consistent psychotherapy in the last 6 months
3) Having a psychotic illness
4) Having current substance abuse or dependence

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)
Participants will be randomised using an electronic random number generator, allocating each participant either a 1 (treatment condition) or 2 (waitlist condition). This will ensure equal treatment groups and true randomisation, such that researchers are not involved in the allocation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using an electronic random number generator, allocating each participant either a 1 (treatment condition) or 2 (waitlist condition).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A priori power analyses using G*power indicates that we will need 128 participants to achieve 80% power to detect a medium effect. To allow for a dropout rate of approximately 30%, we will seek a total of 184 participants (92 treatment; 92 waitlist control).

An intention-to-treat analysis will be used to analyse the data. To examine treatment efficacy, analyses of covariance (ANCOVA) will be used, with baseline levels of treatment outcomes as the covariate. Analysis of clinical significance will also be conducted, in line with guidelines by Dworkin et al. (2005). The proportion of participants improving by 30% or more (reflecting moderate improvement) and 50% or more (reflecting substantial improvement) will be reported for post-treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313535 0
Government body
Name [1] 313535 0
National Health and Medical Research Council
Country [1] 313535 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 315311 0
None
Name [1] 315311 0
Address [1] 315311 0
Country [1] 315311 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312717 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312717 0
Level 3, Administration Building (F23), University of Sydney, NSW, 2006
Ethics committee country [1] 312717 0
Australia
Date submitted for ethics approval [1] 312717 0
06/04/2023
Approval date [1] 312717 0
Ethics approval number [1] 312717 0

Summary
Brief summary
This study primarily aims to evaluate whether a novel online CBT program for fears of death significantly reduces death anxiety amongst individuals with an anxiety-related disorder, compared to a waitlist control group. Given participants in the pilot study demonstrated clinically reliable reductions in death anxiety and other clinical measures after completing the program, we expect a statistically significant reduction in death anxiety amongst individuals with an anxiety disorder compared to the waitlist control will be observed. The study will also explore whether any improvements in death anxiety are associated with improvements in broad mental health.

Furthermore, this study also seeks to obtain qualitative and quantitative feedback on the program, to guide further development. This will be critical to improve the program for future phases of the clinical trial. Given prior user evaluations of online interventions with a similar structure and design to the current program (Helgadottir et al., 2009; Menzies et al., 2023), it is hypothesised that the present intervention will be perceived as user-friendly, clear, acceptable, and efficient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125658 0
Dr Rachel Menzies
Address 125658 0
Brennan MacCallum Building, The University of Sydney, NSW, 2006
Country 125658 0
Australia
Phone 125658 0
+614481350925
Fax 125658 0
Email 125658 0
[email protected]
Contact person for public queries
Name 125659 0
Dr Rachel Menzies
Address 125659 0
Brennan MacCallum Building, The University of Sydney, NSW, 2006
Country 125659 0
Australia
Phone 125659 0
+614481350925
Fax 125659 0
Email 125659 0
[email protected]
Contact person for scientific queries
Name 125660 0
Dr Rachel Menzies
Address 125660 0
Brennan MacCallum Building, The University of Sydney, NSW, 2006
Country 125660 0
Australia
Phone 125660 0
+61 2345678
Fax 125660 0
Email 125660 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18742Study protocol    Upon request to Dr Rachel Menzies, rachel.menzies@... [More Details]
18743Statistical analysis plan    Upon request to Dr Rachel Menzies, rachel.menzies@... [More Details]
18744Informed consent form    Upon request to Dr Rachel Menzies, rachel.menzies@... [More Details]
18745Clinical study report    Upon request to Dr Rachel Menzies, rachel.menzies@... [More Details]
18746Ethical approval    Upon request to Dr Rachel Menzies, rachel.menzies@... [More Details]



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.