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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000219189
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
14/02/2019
Date last updated
14/01/2024
Date data sharing statement initially provided
14/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Stepped- care effectiveness trial for ageing adults with anxiety and depression
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Scientific title
Translating Evidence-Based Psychological Interventions for Older Adults with Depression and Anxiety into Public and Private Mental Health Settings Using a Stepped Care Framework: a clinical and cost-effectiveness trial.
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Secondary ID [1]
297306
0
Nil known
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Universal Trial Number (UTN)
U1111-1228-0250
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
311405
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Anxiety
311406
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Ageing
311407
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Condition category
Condition code
Mental Health
310034
310034
0
0
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Anxiety
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Mental Health
310035
310035
0
0
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Depression
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Public Health
310036
310036
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Stepped Care intervention compromising two steps:
1. STEP 1 (low intensity) choose between: a) Internet program (iCBT): Ten online lessons completed over 10 weeks (one hour per session).
This Cognitive Behavioral Therapy (CBT)- based internet program teaches the older adults skills to help manage and overcome their anxiety and depression. Treatment lessons involve (a) psychoeducation about depression and how cognitive and behavioral factors can main-tain the cycle of depression, (b) behavioural activation, (c) identifying and challenging unhelpful thinking patterns (d) structured problem solving, (e) graded exposure, (f) assertiveness skills training, and (g) relapse prevention. Following each lesson patients are instructed to download homework summaries and complete therapy tasks that reinforce the content of that lesson, prior to next week’s session. Patients complete treatment over 10 weeks with a maximum of one session completed each week. Treatment is fully automated and completed by the patient (e.g. online at home), however, clinicians will contact their patients each week (15 minute phone call) to check on well fare and give support and promote treatment adherence.
b) The telephone supported work at home CBT program is a 10 week program that comprises a work-at-home workbook outlining the skills covered in the Ageing Wisely program (see below) and practice task that are supported by brief (15 minute) weekly therapist telephone calls over 10 weeks.
In both low intensity programs of STEP, the involved clinicians will monitor patients' progress and symptoms through treatment and any questions the patient may have will be answered. Elevated level of distress will be measured using the Kessler 10- item (K10).
At the end of the low intensity program, clinicians will contact the older adult and discuss their progress and continuing needs. They will discuss whether they want to go on to receive face-to-face treatment or if they are sufficiently improved to stop receiving help. Those interested in proceeding will then be offered STEP 2.
2. STEP 2 (high intensity): Individual face-to-face Cognitive Behavioural therapy sessions using a manualised CBT program (Ageing Wisely). This CBT program teaches them skills to manage symptoms of depression and anxiety including: goal setting, activity scheduling, problem solving, graded exposure, cognitive restructuring, assertiveness skills, and sleep hygiene. This program will be delivered one-on-one with a clinician for an hour a week for 11 weeks (to be completed in 13 weeks). If in person visits are not practical, Skype/Zoom sessions or hour long telephone sessions will be offered.
Similar to STEP 1 programs, clinicians at each site will monitor patients’ progress through treatment and will instigate further assessment and emergency procedures as needed. Elevated level of distress will be measured using the Kessler 10- item (K10).
At the end of Step 2, if needed the patients will receive additional therapy and referrals as indicated by the team psychiatrist. Additional therapy may involve a referral to the GP for psychiatric review.
In both STEP 1 and STEP 2, all treatment sessions will be run by, site staff trained in the delivering of the treatment protocols of the stepped care intervention. To control for therapist differences, all therapists will be trained in and will conduct both treatments (allocated randomly).
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Intervention code [1]
313563
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Behaviour
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Comparator / control treatment
Treatment as Usual (TAU): Participants allocated to TAU will receive usual practice at their site parallel to those allocated to the stepped care intervention. What constitutes normal procedures will be extracted from participant files and coded after the study.
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Control group
Active
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Outcomes
Primary outcome [1]
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Changes in illness severity according to the primary outcome measure: the Clinical Global Impression scores (CGI-S)
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Assessment method [1]
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Timepoint [1]
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy) - primary endpoint
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [1]
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Change in Geriatric Anxiety Inventory (GAI- 5) total score,
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Assessment method [1]
366484
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Timepoint [1]
366484
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [2]
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Changes in Geriatric Depression Scale (GDS - 15) total score
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Assessment method [2]
366494
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Timepoint [2]
366494
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [3]
366496
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Changes in Depressive Symptoms Inventory – Suicide Subscale total score
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Assessment method [3]
366496
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Timepoint [3]
366496
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [4]
366505
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Changes on the Kessler Psychological Distress Scale (K10)
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Assessment method [4]
366505
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Timepoint [4]
366505
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [5]
366507
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Changes on the Personality Inventory for DSM-5—Brief Form (PID-5-BF)
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Assessment method [5]
366507
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Timepoint [5]
366507
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [6]
366508
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Changes on the Australian Quality of Life (AQoL-8D) measure (economic evaluation)
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Assessment method [6]
366508
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Timepoint [6]
366508
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [7]
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Changes in Health Resource Use (data extraction) over time - this data will be sources using a purpose built medical cost questionnaire (see secondary outcome 10), supplemented with linked data fro the NSW Centre for Health Record Linkage (CHeRel) on Admitted Patient data, Emergency Department data, and Mental Health Ambulatory data, along with Medicare Benefit Schedule (MBS) and Pharmaceutical Benefit Schedule (PBS) data.
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Assessment method [7]
366511
0
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Timepoint [7]
366511
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At Baseline Assessment - (Prior to program entry and completed during intake) and at the 12 month Follow –up Assessment (12 months from start of therapy)
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Secondary outcome [8]
366514
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Standardised YES (Your Experience of Service) survey - used by NSW mental health services capturing consumer related feedback (participants experiences, benefits, barriers and dislikes).
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Assessment method [8]
366514
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Timepoint [8]
366514
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To be completed at the Post – treatment 13 weeks Assessment - (13 weeks from start of therapy) and at the Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
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Secondary outcome [9]
366515
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Changes on scores on the Use of care Services Survey (Health Resource Use). This survey has been specifically designed for this study and is capturing the frequency and source of use of care services.
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Assessment method [9]
366515
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Timepoint [9]
366515
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [10]
366517
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Changes in scores on the Health of National Outcomes Scale (HoNOS 65+)
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Assessment method [10]
366517
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Timepoint [10]
366517
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1. Baseline Assessment - (Prior to program entry and completed during intake)
2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy)
3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [11]
372650
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Consumer Survey - developed by Research Team
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Assessment method [11]
372650
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Timepoint [11]
372650
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Post – treatment 13 weeks Assessment - (13 weeks from start of therapy) 3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
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Secondary outcome [12]
372651
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Staff Survey - developed by Research Team
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Assessment method [12]
372651
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Timepoint [12]
372651
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Pre and Post Clinician Training Staff Survey - an additional Staff Survey has been created to capture Staffs believes and attitudes towards the new treatment program before (pre- training) and after (post- training) attending a clinician training in the aspects of the treatment program .
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Secondary outcome [13]
372652
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Change in the iMTA Productivity Cost Questionnaire total score
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Assessment method [13]
372652
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Timepoint [13]
372652
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Baseline Assessment - Post – treatment 13 weeks Assessment - (13 weeks from start of therapy) 3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy) 4. Follow –up 12 months Assessment (12 months from start of therapy)
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Secondary outcome [14]
373414
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Diagnostic severity measured using the Anxiety Disorders Interview Schedule 5th edition (ADIS -5).
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Assessment method [14]
373414
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Timepoint [14]
373414
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At baseline Assessment - (Prior to program entry and completed during intake) 2. Post – treatment 13 weeks Assessment - (13 weeks from start of therapy) - primary endpoint 3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy) and 4. Follow –up 12 months Assessment (12 months from start of therapy).
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Eligibility
Key inclusion criteria
Older adults aged 65 years or older; anxiety and/or depression is the main interfering problem according to the intake assessment and indication of significant anxiety and/or depression symptoms on the Health of National Outcomes Scale 65+ (HoNOS 65+). All eligible participants need to have access to either the Internet or a phone.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria will be English language illiteracy, psychosis, bipolar disorder, drug/alcohol dependence, active suicidality, significant uncorrected hearing loss and likely moderate to severe dementia based on standardized cognitive screener tests (varies across sites e.g. six-item Cognitive Impairment Screener, Mini Mental State
Examination (MMSE), Rowland University Dementia Scale (RUDAS), the Montreal Cognitive Assessment (MOCA) or the Addenbrooke’s Cognitive Examination – version 3 (ACE- III)). Participants need to have adequate physical (health) ability to complete Internet/Phone based therapy. Co-morbidity with other psychiatric diagnose (with the exception of psychotic or bipolar disorder) is allowed in order to
establish a clinically relevant, broadly representative sample.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Suitable participants will provide informed consent and will subsequently be randomized within each service to receive the stepped care intervention or treatment as usual using block. A Statistician (independent of the research team) will create the randomisation schedule to allocate individuals to condition. Suitable participants will be randomly allocated by the Research Assistant off site. Due to the nature of randomisation by site, clinicians and participants will not be blinded to condition controlled trial
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
.Randomisation will be based on a computer generated randomisation sequence (www.randomisation.org) entered into sealed envelopes.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The study uses a multi-centre, pragmatic, two- armed parallel group, randomised controlled superiority trail design to evaluate the clinical and cost- effectiveness of a stepped care framework in older adult mental health services in Australia, compared to treatment as usual.
Analyses will be conducted using intention-to-treat and as such all participants will be analysed in the group to which they were randomised. Multiple imputation will be used to manage missing data. Categorical data will be analysed via chi-squared tests, and continuous data with parametric or equivalent non-parametric tests
including mixed linear models, based on random effect models. Descriptive statistics will be used to describe the demographic and clinical characteristics of the two groups and the outcome variables at the four measurements points.
An economic evaluation based on the AQoL-8D and other aspects of the study protocol will also be performed from the health care perspective using Quality Adjusted Life Years (QALYs). A cost utility analysis will compare differences in QALYs with differences in resource use, and presented using an incremental cost effectiveness ratio (ICER).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
12/08/2019
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Actual
26/07/2019
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Date of last participant enrolment
Anticipated
31/12/2023
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
766
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Accrual to date
122
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
13052
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Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
13053
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Macquarie University Hospital - Macquarie Park
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Recruitment hospital [3]
14229
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Bathurst Base Hospital - Bathurst
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Recruitment hospital [4]
14230
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Dubbo Base Hospital - Dubbo
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Recruitment hospital [5]
14231
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Orange Health Service - Orange
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Recruitment hospital [6]
21003
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
25558
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2031 - Randwick
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Recruitment postcode(s) [2]
25559
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2109 - Macquarie Park
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Recruitment postcode(s) [3]
27222
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2795 - Bathurst
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Recruitment postcode(s) [4]
27223
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2830 - Dubbo
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Recruitment postcode(s) [5]
27224
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2800 - Orange
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Recruitment postcode(s) [6]
35836
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2065 - St Leonards
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Funding & Sponsors
Funding source category [1]
301868
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Government body
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Name [1]
301868
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National Health and Medical Research Council (NHMRC)
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Address [1]
301868
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National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra ACT 2601
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Country [1]
301868
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Australia
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Funding source category [2]
301905
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Charities/Societies/Foundations
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Name [2]
301905
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Beyond Blue
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Address [2]
301905
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PO Box 6100
Hawthorn Vic 3122
Australia
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Country [2]
301905
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Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
Macquarie University
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
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Country
Australia
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Secondary sponsor category [1]
301732
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None
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Name [1]
301732
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None
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Address [1]
301732
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Not Applicable
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Country [1]
301732
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302561
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South Eastern Sydney Local Health District (SESLHD)
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Ethics committee address [1]
302561
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Administration Support Officer | Research Support Office
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, RANDWICK NSW 2031
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Ethics committee country [1]
302561
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Australia
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Date submitted for ethics approval [1]
302561
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14/09/2018
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Approval date [1]
302561
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21/12/2018
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Ethics approval number [1]
302561
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18/218 (HREC/18/POWH/447)
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Ethics committee name [2]
303832
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Macquarie University Human Research Ethics Committee Medical Sciences Ethics Committee
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Ethics committee address [2]
303832
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Ethics Secretariat
Research Services| Level 3, 17 Wally’s Walk
Macquarie University, NSW 2109, Australia
T: +61 2 9850 4459 (Administration)
T: +61 2 9850 7850 (HREC: Humanities and Social Sciences)
T: +61 2 9850 4194 (HREC: Medical Sciences)
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Ethics committee country [2]
303832
0
Australia
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Date submitted for ethics approval [2]
303832
0
01/02/2019
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Approval date [2]
303832
0
05/03/2019
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Ethics approval number [2]
303832
0
5201951017095
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Ethics committee name [3]
303833
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South Eastern Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [3]
303833
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Research Support Office
South Eastern Sydney LHD
G71 East Wing Edmund Blacket Building,
Prince of Wales Hospital,
RANDWICK NSW 2031
- Update Awaiting for approval
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Ethics committee country [3]
303833
0
Australia
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Date submitted for ethics approval [3]
303833
0
29/05/2019
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Approval date [3]
303833
0
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Ethics approval number [3]
303833
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SSA reference number 19/G/039.
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Ethics committee name [4]
303834
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Western NSW Local Health District Research ethics Committee - locations Orange, Dubbo and Bathurst
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Ethics committee address [4]
303834
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Research Ethics and Governance | Allied Health
Research Governance Officer
PO Box 143, 39 Hampden Park Road, Bathurst. 2795
Tel (02) 6330 5948 |
[email protected]
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Ethics committee country [4]
303834
0
Australia
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Date submitted for ethics approval [4]
303834
0
14/03/2019
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Approval date [4]
303834
0
03/05/2019
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Ethics approval number [4]
303834
0
SSA/19/GWAHS/16
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Ethics committee name [5]
309754
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Northern Sydney Local Health District Research Ethics Committee
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Ethics committee address [5]
309754
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Level 13, Research Office, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
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Ethics committee country [5]
309754
0
Australia
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Date submitted for ethics approval [5]
309754
0
06/11/2020
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Approval date [5]
309754
0
14/12/2021
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Ethics approval number [5]
309754
0
2020/STE03897
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Summary
Brief summary
The purpose of this study is to test the clinical- and cost- effectiveness of a stepped care psychological interventions compared to treatment as usual for ageing adults with anxiety and depression within existing services representing public (urban, regional) and private mental health organisations.
Evidence-based treatments are more likely to be incorporated within public services when they can demonstrate maximum cost-effectiveness. The results of this study will inform the translation of evidence-based stepped care models of psychological interventions for anxiety and depression in older adults into the Australian mental health system.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Viviana Wuthrich
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Address
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
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Country
90658
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Australia
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Phone
90658
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+61 2 9850 4866
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Fax
90658
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Email
90658
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[email protected]
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Contact person for public queries
Name
90659
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Dr Jessamine Chen
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Address
90659
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
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Country
90659
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Australia
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Phone
90659
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+61 2 9850 9882
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Fax
90659
0
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Email
90659
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[email protected]
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Contact person for scientific queries
Name
90660
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Dr Jessamine Chen
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Address
90660
0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
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Country
90660
0
Australia
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Phone
90660
0
+61 2 9850 9882
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Fax
90660
0
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Email
90660
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
Translating evidence-based psychological interventions for older adults with depression and anxiety into public and private mental health settings using a stepped care framework: Study protocol.
2021
https://dx.doi.org/10.1016/j.cct.2021.106360
N.B. These documents automatically identified may not have been verified by the study sponsor.
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