Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000161527
Ethics application status
Approved
Date submitted
18/01/2024
Date registered
20/02/2024
Date last updated
16/06/2024
Date data sharing statement initially provided
20/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Ageing Wisely Online: a randomised controlled trial of an internet-delivered cognitive behaviour therapy program for older adults with anxiety and depression
Scientific title
Ageing Wisely Online: a randomised controlled trial of an internet-delivered cognitive behaviour therapy program for older adults with anxiety and depression
Secondary ID [1] 311358 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a sub-study to ACTRN12619000219189

Health condition
Health condition(s) or problem(s) studied:
Anxiety 332623 0
Depression 332624 0
Condition category
Condition code
Mental Health 329328 329328 0 0
Anxiety
Mental Health 329329 329329 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study uses a parallel group superiority randomised controlled trial design to evaluate the clinical efficacy of a transdiagnostic internet-delivered cognitive behavioural therapy (iCBT) program for older adults with anxiety and/or depression (Ageing Wisely Online), compared to a delayed-treatment waitlist control group.

Ageing Wisely Online (ageingwisely.org.au) is a 10 module, therapist-supported online Cognitive Behavioural Therapy (CBT) program that is delivered over 10-12 weeks. This program has been co-designed with older consumers and old age mental health clinicians to ensure usability and engagement. The program teaches core CBT skills (psychoeducation, behavioural activation, cognitive restructuring, problem solving, exposure therapy, communication skills, skills to manage sleep problems and relapse prevention) using videos, text, case examples and interactive activities. Clients are expected to complete one module per week (approximately 1hour). Clients will also receive an optional workbook and can elect to complete therapy homework activities either via the online platform, or in a physical workbook. Clients learn and apply the skills independently. Clients are supported by weekly manualised 15-minute phone calls from therapists after they have completed each module to support them to apply the skills to their personal situation, and to help maintain motivation. Treatment adherence and completion of online modules will be monitored via online access records, as well as verbal reports to therapists during the weekly phone calls.
Intervention code [1] 327801 0
Behaviour
Intervention code [2] 327931 0
Treatment: Other
Comparator / control treatment
Participants in the waitlist condition will receive access to the Ageing Wisely program after six months. They will complete assessments at baseline, 12 weeks post-baseline and 24-weeks post-baseline to monitor symptoms. Waitlist participants will then receive access to the full Ageing Wisely Online intervention.
Control group
Active

Outcomes
Primary outcome [1] 337138 0
Group differences in change in primary disorder severity from pre-post treatment.
Timepoint [1] 337138 0
Assessed at baseline (pre-treatment) and again 12-weeks after starting treatment (post-treatment)
Primary outcome [2] 337139 0
Group differences in change in primary disorder severity from pre-treatment to 3-month follow-up.
Timepoint [2] 337139 0
Assessed at baseline (pre-treatment) and at 3-month follow-up (12-weeks post-treatment). Primary timepoint is post-treatment.
Secondary outcome [1] 430845 0
Group differences in cumulative diagnostic severity of all anxiety and/or depressive diagnoses from pre-post treatment. A composite secondary outcome will be calculated using cumulative severity score of all anxiety and depressive diagnoses.
Timepoint [1] 430845 0
Assessed at baseline (pre-treatment) and again 12-weeks after starting treatment (post-treatment).
Secondary outcome [2] 430846 0
Group differences in cumulative diagnostic severity of all anxiety and/or depressive diagnoses from pre-treatment to 3-month follow-up. A composite secondary outcome will be calculated using cumulative severity score of all anxiety and depressive diagnoses.
Timepoint [2] 430846 0
Assessed at baseline (pre-treatment) and at 3-month follow-up (12-weeks post-treatment).
Secondary outcome [3] 430847 0
Group differences in diagnostic remission of the primary disorder at post-treatment
Timepoint [3] 430847 0
Assessed at 12-weeks after starting treatment (post-treatment)
Secondary outcome [4] 430848 0
Group differences in diagnostic remission of the primary disorder at 3-month follow-up
Timepoint [4] 430848 0
Assessed at 3-month follow-up (12-weeks post-treatment).
Secondary outcome [5] 430849 0
Group differences in diagnostic remission of all anxiety and depressive disorders at post-treatment
Timepoint [5] 430849 0
Assessed at 12-weeks after starting treatment (post-treatment)
Secondary outcome [6] 430850 0
Group differences in diagnostic remission of all anxiety and depressive disorders at 3-month follow-up
Timepoint [6] 430850 0
Assessed at 3-month follow-up (12-weeks post-treatment).
Secondary outcome [7] 430851 0
User satisfaction of Ageing Wisely
Timepoint [7] 430851 0
Assessed at 12-weeks after starting treatment (post-treatment)
Secondary outcome [8] 430852 0
Group differences in Quality Adjusted Life Years (QALY) from baseline to post-treatment
Timepoint [8] 430852 0
Assessed at baseline (pre-treatment) and again 12-weeks after starting treatment (post-treatment).
Secondary outcome [9] 430855 0
Group differences in Quality Adjusted Life Years (QALY) from baseline to 3-month follow-up
Timepoint [9] 430855 0
Assessed at baseline (pre-treatment) and at 3-month follow-up (12-weeks post-treatment).
Secondary outcome [10] 431427 0
Therapeutic alliance during Ageing Wisely Online treatment
Timepoint [10] 431427 0
Assessed at 12-weeks after starting treatment (post-treatment)

Eligibility
Key inclusion criteria
Aged over 65 years
Primary anxiety and/or unipolar depressive disorders based on a semi-structured diagnostic interview (Anxiety Disorder Interview Schedule for DSM-5).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
English language illiteracy, psychosis or bipolar disorder, active suicidality, significant uncorrected hearing or vision loss and likely moderate to severe dementia based on a standardized cognitive screener.

Participants currently using (psychotropic) medications will not be excluded, but need to be stabilised on medications and dose for 1 month before baseline assessments.

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)
The randomisation schedule will be placed into consecutively numbered sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using a computerised randomiser by an independent statistician
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/02/2024
Actual
26/02/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
68
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315619 0
Government body
Name [1] 315619 0
NHMRC-National Health and Medical Research Council
Country [1] 315619 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 317711 0
None
Name [1] 317711 0
Address [1] 317711 0
Country [1] 317711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314501 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 314501 0
Ethics committee country [1] 314501 0
Australia
Date submitted for ethics approval [1] 314501 0
20/11/2023
Approval date [1] 314501 0
06/12/2023
Ethics approval number [1] 314501 0
520231631954490

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

Contacts
Principal investigator
Name 131810 0
A/Prof Carly Johnco
Address 131810 0
School of Psychological Sciences, Australian Hearing Hub, 16 University Ave, Macquarie University NSW 2109
Country 131810 0
Australia
Phone 131810 0
+61298508053
Fax 131810 0
Email 131810 0
carly.johnco@mq.edu.au
Contact person for public queries
Name 131811 0
Carly Johnco
Address 131811 0
School of Psychological Sciences, Australian Hearing Hub, 16 University Ave, Macquarie University NSW 2109
Country 131811 0
Australia
Phone 131811 0
+61298508053
Fax 131811 0
Email 131811 0
carly.johnco@mq.edu.au
Contact person for scientific queries
Name 131812 0
Carly Johnco
Address 131812 0
School of Psychological Sciences, Australian Hearing Hub, 16 University Ave, Macquarie University NSW 2109
Country 131812 0
Australia
Phone 131812 0
+61298508053
Fax 131812 0
Email 131812 0
carly.johnco@mq.edu.au

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
21435Clinical study report  carly.johnco@mq.edu.au



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.