Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000315516
Ethics application status
Approved
Date submitted
27/02/2024
Date registered
25/03/2024
Date last updated
9/08/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
CYBERABILITY: Piloting the Smooth Sailing After Scams adjustment program
Scientific title
CYBERABILITY: Piloting the Smooth Sailing After Scams adjustment program addressing levels of distress and coping in cyberscam survivors.
Secondary ID [1] 311455 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 332751 0
Mental health 332752 0
Adjustment disorder 332753 0
Condition category
Condition code
Mental Health 329473 329473 0 0
Depression
Mental Health 329474 329474 0 0
Anxiety
Physical Medicine / Rehabilitation 329475 329475 0 0
Other physical medicine / rehabilitation
Mental Health 329912 329912 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program consists of ten weekly group or individual therapy sessions of approximately 60 minutes. The sessions are delivered by allied health clinicians (i.e., clinical neuropsychologists, clinical psychologists, provisional psychologists under supervision, occupational therapists, speech therapists). People with lived experience will co-facilitate up to four sessions where required. Participants have the choice of attending sessions via videoconference or in person. Therapists will follow a structured treatment manual, whilst adopting a person-driven approach.

This treatment manual was extensively co-designed with cyberscam survivors with acquired brain injury (ABI), caregivers and clinicians. Fifteen cyberscam survivors with acquired brain injury (ABI), caregivers, clinicians and service provider took part in eight 2.5-hour hybrid focus groups delivered over a period of eight weeks, to co-design the treatment manual. Participants were presented with draft content on recommended intervention approaches and priorities based on our previous scoping research with these stakeholder groups. They were invited to provide feedback and generate ideas throughout each group. Additional meetings were held with the research team to refine and integrate the ideas into a structured intervention manual. Following these meetings, eight more meetings were held with clinician and service provider participants to discuss and gather more feedback on the structured manual. Four steering committee meetings with industry stakeholders from the brain injury and cybersecurity sectors were also held to provide strategic advice on the intervention content, and promotion and sustainability plans.

The treatment manual consists of modules, with accompanying handouts. Session 1 is a 1:1 introduction to the program. Sessions 2-3 focus on scams and cybersafety. Sessions 4-5 focus on financial management and strategies. Sessions 6-7 focus on emotions. Sessions 8-9 focus on relationships and lifestyle. Session 10 is a summary of the content and strategies learnt.

Sessions will involve provision of brief information through short videos and handouts, semi-structured group discussions among participants, facilitated by the therapist and lived experience facilitator, and exploration of practical strategies to implement between sessions. There will be approximately 2-4 participants in a group, with 1:1 delivery also available.
Strategies used to monitor adherence to the intervention include session attendance checklists, audio-visual recording of sessions to allow for analyses of treatment fidelity and regular supervision with therapists by the project lead.

For individuals who attend sessions via videoconference, handouts will be delivered via email or hardcopy post depending on the participants preference.

Researchers will determine whether participants receive the intervention in a group or individual setting on a case-by-case basis, based on screening with the individual (and a close other or clinician) to determine their cognitive, behavioural and communicative ability, and other accessibility factors (e.g. if home visits are required to provide the intervention). In addition, individuals who would clinically benefit from more immediate support rather than waiting until the next available structured group program, will also be considered for individually delivered intervention.
Intervention code [1] 327902 0
Rehabilitation
Comparator / control treatment
No untreated control group. A multiple baseline single-case study design will be used. Participants will act as their own controls by comparing changes occurring during a non-treatment baseline phase with that during the intervention and follow-up phases. Participants will be randomly assigned to 2, 4 or 6 weeks baseline lengths before starting the intervention. All participants will receive the same intervention at the conclusion of the baseline phase.
Control group
Active

Outcomes
Primary outcome [1] 337284 0
Subjective levels of distress.
Timepoint [1] 337284 0
This measure will be completed 3 times a week throughout the study duration (i.e., baseline phase, during the intervention phase, throughout 2-month follow-up period). Participants will complete this across 20 to 24 weeks depending on the length of their baseline phase.
Primary outcome [2] 337676 0
Subjective levels of coping.
Timepoint [2] 337676 0
This measure will be completed 3 times a week throughout the study duration (i.e., baseline phase, during the intervention phase, throughout 2-month follow-up period). Participants will complete this across 20 to 24 weeks depending on the length of their baseline phase.
Primary outcome [3] 337677 0
Scam adjustment stage.
Timepoint [3] 337677 0
Start of baseline (T1), Pre-intervention (T2; i.e., end of baseline period), During the intervention (at all 10 sessions), Post-intervention (T3; i.e., post-completion of intervention), 2-month follow-up (T4).
Secondary outcome [1] 431321 0
The CyberAbility Scale is a co-designed tailored measure, which includes self-report and objective measures of cybersafety. This is currently undergoing validation.
Timepoint [1] 431321 0
Start of baseline (T1), Pre-intervention (T2; i.e., end of baseline period), Post-intervention (T3; i.e., post-completion of intervention), 2-month follow-up (T4).
Secondary outcome [2] 431322 0
Global measure of psychological distress.
Timepoint [2] 431322 0
Start of baseline (T1), Pre-intervention (T2; i.e., end of baseline period), Post-intervention (T3; i.e., post-completion of intervention), 2-month follow-up (T4).
Secondary outcome [3] 431323 0
Financial strategy count. This is a tailored 8-item measure assessing number of financial strategies used to keep money safe.
Timepoint [3] 431323 0
Start of baseline (T1), Pre-intervention (T2; i.e., end of baseline period), Post-intervention (T3; i.e., post-completion of intervention), 2-month follow-up (T4).
Secondary outcome [4] 431324 0
Social relationships measure. This is a tailored 2-item measure assessing relationship with caregivers, friends and social connections in the context of the scam.
Timepoint [4] 431324 0
Start of baseline (T1), Pre-intervention (T2; i.e., end of baseline period), Post-intervention (T3; i.e., post-completion of intervention), 2-month follow-up (T4).
Secondary outcome [5] 431325 0
Goal Attainment Scaling (GAS). This evaluates the extent to which a person's personalised goals of return to activity are attained during the course of the intervention.
Timepoint [5] 431325 0
Start of baseline (T1), Pre-intervention (T2; i.e., end of baseline period), Post-intervention (T3; i.e., post-completion of intervention), 2-month follow-up (T4).
Secondary outcome [6] 431326 0
Subjective rating of survivor's cybersafety. This is a tailored 2-item measure completed by the the survivor's close other.
Timepoint [6] 431326 0
Start of baseline (T1), Pre-intervention (T2; i.e., end of baseline period), Post-intervention (T3; i.e., post-completion of intervention), 2-month follow-up (T4).

Eligibility
Key inclusion criteria
Cyberscam survivors
o 18 years of age or older
o Experienced a scam or others believe the person to have experienced a scam
o Experiencing adjustment or mood difficulty after being scammed
o Have sufficient cognitive capacity to understand plain language explanatory statement, provide informed consent, engage in therapy tasks and complete questionnaires

Close other
o 18 years of age or older
o Relative or primary support person or key friend of a cyberscam survivor participating in this study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cyberscam survivors
o Have current significant psychiatric disorder, alcohol and/or drug use, measured as Level 3 – moderate on items 3, 6, 7 and 8 of the Health of the National Outcome Scales for Acquired Brain Injury (HoNOS-ABI) unrelated to the scam
o Do not have sufficient cognitive capacity required for the study
o Live outside of Australasia

Close others
o Live outside of Australasia

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using an envelope system. Participants will be randomly allocated to one of either a 2, 4, or 6-week baseline period before commencing the intervention. A researcher not connected to the study will prepare a set of sealed envelopes, each containing a baseline length assignment. Once a participant has been enrolled in the study, the researcher will randomly select an envelope from the set of prepared envelopes to determine the baseline length the participant is allocated to.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study uses a concurrent multiple-baseline single case experimental design. Participants will act as their own controls, and be randomised into baseline lengths of 2, 4 or 6 weeks. Participants in all baseline groups will receive the same intervention at the conclusion of the baseline period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome measures will be analysed using visual and statistical analysis. Subjective levels of distress and coping will be displayed graphically using Graphpad Prism 7. This will be evaluated using established visual analysis guidelines that incorporate within- and between-condition analysis (Lane & Gast, 2014). Effect sizes will be estimated to support visual analysis findings if there is a functional effect present.

Effect sizes will be analysed statistically using the Tau-U statistic, which is a nonparametric index of the percentage of data not overlapped between baseline and intervention phases (Parker, 2014). Tau-U is appropriate for small datasets, is robust to outliers, corrects for a baseline trend, and provides an overall effect size. An online calculator will be used for analysis: http://www.singlecaseresearch.org/calculators/tau-u. Effect sizes will be used to interpret the findings instead of focusing on p-values to account for autocorrelation (Vannest, 2018). Tau-U values below 0.2 will be considered small, 0.2 - 0.6 medium, 0.6 – 0.8 large and greater than 0.8 large to very large.

Paired-samples t tests (normal distribution) or Wilcoxin (nonnormal distribution) will be performed to compare mood, scam awareness, financial strategies, and social relationships data recorded at baseline, pre-intervention, post-intervention, and 2-month follow-up assessments. Functional change on GAS goals will be descriptively explored. Any change will be considered to have clinical significance (Perdices, 2005). NVivo software will be used to store and analyse interview transcripts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/04/2024
Actual
23/05/2024
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
23/10/2026
Actual
Sample size
Target
15
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 42048 0
3168 - Notting Hill

Funding & Sponsors
Funding source category [1] 315734 0
University
Name [1] 315734 0
Monash University
Country [1] 315734 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 317847 0
None
Name [1] 317847 0
Address [1] 317847 0
Country [1] 317847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314598 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314598 0
Ethics committee country [1] 314598 0
Australia
Date submitted for ethics approval [1] 314598 0
23/01/2024
Approval date [1] 314598 0
12/02/2024
Ethics approval number [1] 314598 0
41149

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

Contacts
Principal investigator
Name 132134 0
Dr Kate Gould
Address 132134 0
Monash-Epworth Rehabilitation Research Centre, Turner Institute of Brain and Mental Health, School of Psychological Sciences, Monash University, Building 1/270 Ferntree Gully Road Notting Hill Vic 3168 Australia
Country 132134 0
Australia
Phone 132134 0
+61 3 9902 4480
Fax 132134 0
Email 132134 0
[email protected]
Contact person for public queries
Name 132135 0
Dr Kate Gould
Address 132135 0
Monash-Epworth Rehabilitation Research Centre, Turner Institute of Brain and Mental Health, School of Psychological Sciences, Monash University, Building 1/270 Ferntree Gully Road Notting Hill Vic 3168 Australia
Country 132135 0
Australia
Phone 132135 0
+61 3 9902 4480
Fax 132135 0
Email 132135 0
[email protected]
Contact person for scientific queries
Name 132136 0
Dr Kate Gould
Address 132136 0
Monash-Epworth Rehabilitation Research Centre, Turner Institute of Brain and Mental Health, School of Psychological Sciences, Monash University, Building 1/270 Ferntree Gully Road Notting Hill Vic 3168 Australia
Country 132136 0
Australia
Phone 132136 0
+61 3 9902 4480
Fax 132136 0
Email 132136 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?

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.