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

Not Applicable

• Conditions: Depression - anxiety - ageing - stepped care; Mental and Behavioural Disorders

• Registration Number: ISRCTN37503850
• Lead Sponsor: Macquarie University

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33766760/ (added 29/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-15
• Last Update Posted: 9 January 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 666

Inclusion Criteria

1. Older adults aged 65 years or older
2. 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+)
3. Access to either the Internet or a phone

Exclusion Criteria

1. English language illiteracy
2. Psychosis
3. Bipolar disorder
4. Drug/alcohol dependence
5. Active suicidality
6. Significant uncorrected hearing loss
7. 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))
8. Participants need to have adequate physical (health) ability to complete internet/phone based therapy
9. Co-morbidity with other psychiatric diagnoses (with the exception of psychotic or bipolar disorder) is allowed in order to establish a clinically relevant, broadly representative sample

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Illness severity assessed using the Clinical Global Impression scores (CGI-S) at baseline assessment - (prior to program entry and completed during intake), post-treatment 13 weeks assessment (13 weeks from start of therapy), primary endpoint post-treatment 26 weeks assessment (26 weeks from start of therapy), and follow –up 12 months assessment (12 months from start of therapy)