Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: Suitable participants will provide informed consent and will subsequently be randomized within each service to receive the stepped care intervention or treatment as usual in block. A Faculty 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 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 behavioural factors can maintain 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 bel CONDITION: Depression ‐ anxiety ‐ ageing ‐ stepped care ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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) SECONDARY OUTCOME: ; 1. Anxiety symptoms measured by the Geriatric Anxiety Inventory (GAI‐ 5) total score 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); 2. Depressive symptoms measured by the Geriatric Depression Scale (GDS ‐ 15) total score is assessed 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); 3. Depressive symptoms measured using the Depressive Symptoms Inventory – Suicide Subscale total score 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); 4. Diagnostic severity measured using the Anxiety Disorders Interview Schedule 5th edition (ADIS ‐5) for DSM‐5 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); 5. Personality traits measured using the Personality Inventory for DSM‐5—Brief Form (PID‐5‐BF) 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); 6. Quality of life and health outcomes across eight domains measured using the Australian Quality of Life (AQoL‐8D) measure (economic evaluation) 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); 7. Health resource use (data extraction) over time measured using a purpose‐built medical cost questionnaire (see secondary outcome 10), supplemented with linked data from 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 and captured 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); 8. Consumer‐related feedback (participants experiences, benefits, barriers and dislikes) captured using standardised YES (Your Experience of Service) survey used by NSW mental health services completed by the client 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); 9. Frequency and source of use of care services measured using the Use of care Services Survey (Health Resource Use) 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); 10. Behaviour, impairment, symptoms and social functioning measured using the Health of National Outcomes Scale (HoNOS 65+) 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); 11. Patient and therapist satisfaction with the treatment program offered evaluated using consumer and staff surveys. The consumer survey will be administered at the post‐treatment 13 weeks assessment (13 weeks from start of therapy) and the post‐treatment 26 weeks assessment (26 weeks from start of therapy). The staff survey will be administered annually and completed by each clinician involved.; 12. Staff beliefs and attitudes towards the new treatment program measured using an additional staff survey before and after attending a clinician training in the aspects of the treatment program; 13. Health‐related productivity losses including presenteeism and absenteeism in paid and unpaid work measured using the iMTA Productivity Cost Questionnaire total score administered 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); ; Previous secondary outcome measure 4:; 4. Diagnostic severity measured using the Structured Clinical Interview. International Neuropsychiatric Interview (M.I.N.I. version 7.0.2 for DSM‐5) 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); 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
Epistemonikos ID: 72a0be5128f1d8c5063afd2a544d021b8586f0af
First added on: Aug 24, 2024