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Trial registered on ANZCTR


Registration number
ACTRN12619000242123
Ethics application status
Approved
Date submitted
8/02/2019
Date registered
19/02/2019
Date last updated
14/01/2024
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Mental Health and Social Participation Outcomes in Older Adults with Depression and Anxiety
Scientific title
Improving Mental Health and Social Participation Outcomes in Older Adults with Depression and Anxiety
Secondary ID [1] 297315 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 311424 0
Depression 311426 0
Condition category
Condition code
Mental Health 310053 310053 0 0
Anxiety
Mental Health 310055 310055 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one-hour one-on-one session per week for 12 weeks using manualised CBT based on the empirically validated CBT program for older age anxiety and depression, Ageing Wisely. The enhanced CBT program teaches the same CBT skills as the standard CBT program, but with a stronger focus on bolstering social participation and connections within those skills. That is, in the enhanced CBT program, standard CBT techniques such as goal setting, activity scheduling, and graded exposure, are specifically focused around social connections, maximising family and community support, and social contribution. Modules of social connection are integrated into the standard CBT program and module length varies from session to session.

Treatment is delivered by Clinical Psychologists and Clinical Psychology registrars, supervised by Chief Investigators to ensure treatment adherence. Adherence of participants to treatment will be monitored with 20% of the sessions coded for fidelity by an independent rater.
Intervention code [1] 313588 0
Behaviour
Comparator / control treatment
Standard CBT: one-hour one-on-one session per week for 12 weeks using the empirically validated CBT program for older age anxiety and depression, Ageing Wisely. This program includes generic CBT skills such as psycho-education, problem-solving, cognitive restructuring, sleep hygiene, and graded exposure which is a core skill for treatment of anxiety, and activity scheduling which is a core skill for the treatment of depression.

The two programs differ in that the enhanced program has a stronger focus on bolstering social participation and connections within those skills relative to the standard CBT program.
Control group
Active

Outcomes
Primary outcome [1] 318987 0
Mean Clinician’s Severity Rating of anxiety and mood disorders based on the Anxiety and Related Disorders Interview Schedule 5th edition (ADIS-V) posttreatment.
Timepoint [1] 318987 0
14 weeks from baseline assessment.
Secondary outcome [1] 366635 0
Change in Clinician’s Severity Rating of anxiety disorders based on the ADIS-V.
Timepoint [1] 366635 0
12 months from start of therapy.
Secondary outcome [2] 366636 0
Change in Geriatric Anxiety Inventory total score.
Timepoint [2] 366636 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [3] 366637 0
Change in Geriatric Anxiety Scale total score.
Timepoint [3] 366637 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [4] 366638 0
Change in Geriatric Depression Scale total score.
Timepoint [4] 366638 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [5] 366639 0
Change in Depressive Symptoms Inventory – Suicide Subscale score.
Timepoint [5] 366639 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [6] 366640 0
Change in De Jong Gierveld Loneliness Scales total score.
Timepoint [6] 366640 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [7] 366641 0
Change in The Lubben Social Network Scale total score.
Timepoint [7] 366641 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [8] 366642 0
Change in the Bille- Brahe Social Support Scale total score.
Timepoint [8] 366642 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [9] 366643 0
Change in the Australian Quality of Life total score.
Timepoint [9] 366643 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [10] 366644 0
Change in the iMTA Productivity Cost Questionnaire total score.
Timepoint [10] 366644 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [11] 366645 0
Change in the Australian Community Participation Questionnaire short form total score.
Timepoint [11] 366645 0
14 weeks from baseline assessment and 12 months from start of therapy.
Secondary outcome [12] 366650 0
Change in Use of Service Questionnaire total score. This purpose built medical cost questionnaire was designed specifically for this study.
Timepoint [12] 366650 0
14 weeks from baseline assessment and 12 months from start of therapy.

Eligibility
Key inclusion criteria
Older adults aged 65 years of older
Primary anxiety and/or unipolar depressive disorder as assessed by the Anxiety Disorders Interview Schedule (ADIS-V).
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 loss and likely moderate to severe dementia based on a standardised cognitive screener test (i.e. the scores on the six-item Cognitive impairment Screener).

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)
Eligible participants will provide informed consent and will subsequently be randomised to receive the standard CBT or Enhanced CBT in a 1:1 ratio. A statistician (independent of the research team) will create the randomisation schedule to allocate individuals to condition. Block randomisation will be used to ensure that the two comparison groups are the same size. Due to the nature of randomisation, clinicians and participants will not be blinded to condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using a computerised randomizer (www.randomizer.org) and placed into consecutively numbered sealed envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using intention-to-treat principles. All participants will be included in analyses based on the condition to which they were initially allocated. Multiple imputation will be used to manage missing data. The efficacy of the programs will be established using mixed model analysis to compare the mean differences in clinical diagnostic severity (established by clinicians who are blind to treatment allocation) and scores on self-report measures at pre-treatment, post-treatment, and at a 12-month follow-up period.

Analysis will be a mixed model with random subject effect, fixed effects relating to group allocation (between-group), time (within-subject) and covariates. Interaction contrasts will be used if the time x group interaction reaches statistical significance, but the main effect contrast will be used if not.

An economic evaluation will be conducted from the healthcare system perspective. Health outcomes captured through the AQoL-8D will be evaluated using Quality Adjusted Life Years (QALYs). Intervention and resulting costs per patient in the enhanced CBT group will be compared against those in the standard CBT group, and include acute care, primary care, mental health care, community care, and medication use.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/07/2019
Actual
16/07/2019
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
172
Accrual to date
167
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301879 0
Government body
Name [1] 301879 0
National Health and Medical Research Council
Country [1] 301879 0
Australia
Funding source category [2] 301904 0
Charities/Societies/Foundations
Name [2] 301904 0
Beyond Blue
Country [2] 301904 0
Australia
Primary sponsor type
University
Name
Centre for Emotional Health, Macquarie University
Address
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW 2109
Country
Australia
Secondary sponsor category [1] 301659 0
None
Name [1] 301659 0
Address [1] 301659 0
Country [1] 301659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302570 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 302570 0
Ethics committee country [1] 302570 0
Australia
Date submitted for ethics approval [1] 302570 0
15/11/2018
Approval date [1] 302570 0
24/01/2019
Ethics approval number [1] 302570 0
5201938336887
Ethics committee name [2] 303054 0
Centre for Health Record Linkage Ethics Committee
Ethics committee address [2] 303054 0
Ethics committee country [2] 303054 0
Australia
Date submitted for ethics approval [2] 303054 0
Approval date [2] 303054 0
Ethics approval number [2] 303054 0

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

Contacts
Principal investigator
Name 90694 0
Prof Viviana Wuthrich
Address 90694 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road
North Ryde NSW 2109
Country 90694 0
Australia
Phone 90694 0
+612 9850 4866
Fax 90694 0
+612 9850 8062
Email 90694 0
viviana.wuthrich@mq.edu.au
Contact person for public queries
Name 90695 0
Jessamine Chen
Address 90695 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road
North Ryde NSW 2109
Country 90695 0
Australia
Phone 90695 0
+612 9850 9882
Fax 90695 0
N/A
Email 90695 0
jessamine.chen@mq.edu.au
Contact person for scientific queries
Name 90696 0
Viviana Wuthrich
Address 90696 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road
North Ryde NSW 2109
Country 90696 0
Australia
Phone 90696 0
+612 9850 4866
Fax 90696 0
+612 9850 8062
Email 90696 0
viviana.wuthrich@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?

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
SourceTitleYear of PublicationDOI
EmbaseImproving mental health and social participation outcomes in older adults with depression and anxiety: Study protocol for a randomised controlled trial.2022https://dx.doi.org/10.1371/journal.pone.0269981
N.B. These documents automatically identified may not have been verified by the study sponsor.