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Stepped- care effectiveness trial for ageing adults with anxiety and depression

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000219189
Enrollment
122
Registered
2019-02-14
Start date
2019-07-26
Completion date
2023-01-17
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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) behaviour

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).

Sponsors

Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026