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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
1/08/2019
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
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.
Secondary ID [1] 297306 0
Nil known
Universal Trial Number (UTN)
U1111-1228-0250
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311405 0
Anxiety 311406 0
Ageing 311407 0
Condition category
Condition code
Mental Health 310034 310034 0 0
Anxiety
Mental Health 310035 310035 0 0
Depression
Public Health 310036 310036 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stepped Care intervention compromising two steps:
1. STEP 1 (low intensity) choose between: a) Internet program (iCBT): Six 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 (Happy Healthy Ageing) 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).
Intervention code [1] 313563 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 318942 0
Changes in illness severity according to the primary outcome measure: the Clinical Global Impression scores (CGI-S)
Timepoint [1] 318942 0
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)
Secondary outcome [1] 366484 0
Change in Geriatric Anxiety Inventory (GAI- 5) total score,
Timepoint [1] 366484 0
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)
Secondary outcome [2] 366494 0
Changes in Geriatric Depression Scale (GDS - 15) total score
Timepoint [2] 366494 0
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)
Secondary outcome [3] 366496 0
Changes in Depressive Symptoms Inventory – Suicide Subscale total score
Timepoint [3] 366496 0
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)
Secondary outcome [4] 366505 0
Changes on the Kessler Psychological Distress Scale (K10)
Timepoint [4] 366505 0
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)
Secondary outcome [5] 366507 0
Changes on the Personality Inventory for DSM-5—Brief Form (PID-5-BF)
Timepoint [5] 366507 0
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)
Secondary outcome [6] 366508 0
Changes on the Australian Quality of Life (AQoL-8D) measure (economic evaluation)
Timepoint [6] 366508 0
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)
Secondary outcome [7] 366511 0
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.
Timepoint [7] 366511 0
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)
Secondary outcome [8] 366514 0
Standardised YES (Your Experience of Service) survey - used by NSW mental health services capturing consumer related feedback (participants experiences, benefits, barriers and dislikes).
Timepoint [8] 366514 0
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)
Secondary outcome [9] 366515 0
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.
Timepoint [9] 366515 0
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)
Secondary outcome [10] 366517 0
Changes in scores on the Health of National Outcomes Scale (HoNOS 65+)
Timepoint [10] 366517 0
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)
Secondary outcome [11] 372650 0
Consumer Survey - developed by Research Team
Timepoint [11] 372650 0
Post – treatment 13 weeks Assessment - (13 weeks from start of therapy) 3. Post – treatment 26 weeks Assessment (26 weeks from start of therapy)
Secondary outcome [12] 372651 0
Staff Survey - developed by Research Team
Timepoint [12] 372651 0
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 .
Secondary outcome [13] 372652 0
Change in the iMTA Productivity Cost Questionnaire total score
Timepoint [13] 372652 0
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)
Secondary outcome [14] 373414 0
Diagnostic severity measured using the Anxiety Disorders Interview Schedule 5th edition (ADIS -5).
Timepoint [14] 373414 0
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).

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.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
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
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.
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
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13052 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 13053 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [3] 14229 0
Bathurst Base Hospital - Bathurst
Recruitment hospital [4] 14230 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [5] 14231 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 25558 0
2031 - Randwick
Recruitment postcode(s) [2] 25559 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 27222 0
2795 - Bathurst
Recruitment postcode(s) [4] 27223 0
2830 - Dubbo
Recruitment postcode(s) [5] 27224 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 301868 0
Government body
Name [1] 301868 0
National Health and Medical Research Council (NHMRC)
Address [1] 301868 0
National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra ACT 2601
Country [1] 301868 0
Australia
Funding source category [2] 301905 0
Charities/Societies/Foundations
Name [2] 301905 0
Beyond Blue
Address [2] 301905 0
PO Box 6100
Hawthorn Vic 3122
Australia
Country [2] 301905 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
Country
Australia
Secondary sponsor category [1] 301732 0
None
Name [1] 301732 0
None
Address [1] 301732 0
Not Applicable
Country [1] 301732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302561 0
South Eastern Sydney Local Health District (SESLHD)
Ethics committee address [1] 302561 0
Administration Support Officer | Research Support Office
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, RANDWICK NSW 2031
Ethics committee country [1] 302561 0
Australia
Date submitted for ethics approval [1] 302561 0
14/09/2018
Approval date [1] 302561 0
21/12/2018
Ethics approval number [1] 302561 0
18/218 (HREC/18/POWH/447)
Ethics committee name [2] 303832 0
Macquarie University Human Research Ethics Committee Medical Sciences Ethics Committee
Ethics committee address [2] 303832 0
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)
Ethics committee country [2] 303832 0
Australia
Date submitted for ethics approval [2] 303832 0
01/02/2019
Approval date [2] 303832 0
05/03/2019
Ethics approval number [2] 303832 0
5201951017095
Ethics committee name [3] 303833 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [3] 303833 0
Research Support Office
South Eastern Sydney LHD
G71 East Wing Edmund Blacket Building,
Prince of Wales Hospital,
RANDWICK NSW 2031

- Update Awaiting for approval
Ethics committee country [3] 303833 0
Australia
Date submitted for ethics approval [3] 303833 0
29/05/2019
Approval date [3] 303833 0
Ethics approval number [3] 303833 0
SSA reference number 19/G/039.
Ethics committee name [4] 303834 0
Western NSW Local Health District Research ethics Committee - locations Orange, Dubbo and Bathurst
Ethics committee address [4] 303834 0
Research Ethics and Governance | Allied Health
Research Governance Officer
PO Box 143, 39 Hampden Park Road, Bathurst. 2795
Tel (02) 6330 5948 | Phil.Sanders@health.nsw.gov.au
Ethics committee country [4] 303834 0
Australia
Date submitted for ethics approval [4] 303834 0
14/03/2019
Approval date [4] 303834 0
03/05/2019
Ethics approval number [4] 303834 0
SSA/19/GWAHS/16

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90658 0
Prof Viviana Wuthrich
Address 90658 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
Country 90658 0
Australia
Phone 90658 0
+61 2 9850 4866
Fax 90658 0
Email 90658 0
Viviana.Wuthrich@mq.edu.au
Contact person for public queries
Name 90659 0
Dr Denise Meuldijk
Address 90659 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
Country 90659 0
Australia
Phone 90659 0
+61 2 9850 8655
Fax 90659 0
Email 90659 0
denise.meuldijk@mq.edu.au
Contact person for scientific queries
Name 90660 0
Dr Denise Meuldijk
Address 90660 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde, NSW, Australia 2109
Country 90660 0
Australia
Phone 90660 0
+61 2 9850 8655
Fax 90660 0
Email 90660 0
denise.meuldijk@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 other documents available
Summary results
No Results