Improving mental health and social participation outcomes in older adults with depression and anxiety

INTERVENTION: The main study design uses a parallel group superiority randomised controlled trial design to evaluate the clinical and cost‐effectiveness of an enhanced CBT program for depressive and/or anxiety disorders in older adults, compared to standard CBT. ). After baseline examination suitable participants will be randomised to either the 1) Standard CBT or 2) Enhanced CBT treatment condition. The standard CBT program will comprise our empirically validated CBT program for older age anxiety and depression, Ageing Wisely. Ageing Wisely consists of 11, weekly sessions to teach practical skills to help manage anxiety and depression including: goal setting, activity scheduling, problem solving, graded exposure, cognitive restructuring, assertiveness skills, and sleep hygiene. For the current trial we will add one treatment session to equate contact hours between treatment conditions. Homework exercises are a critical component that assists skills to be generalised and maintained. The enhanced CBT program comprises 12 weekly sessions, teaching the same CBT skills as the standard Ageing Wisely program, but with a stronger focus on bolstering social participation and connections within those skills. In both treatment conditions, all sessions will be run by clinical psychologists and intern psychologists trained in the delivering of the treatment protocols. To control for therapist differences, all therapists will be trained in and will conduct both treatments (allocated randomly). Supervision will be provided by CIs and postdoctoral fellows managing the trial with treatment adherence and differentiation between conditions as a core focus. All therapy sessions will be recorded, and a random 25% will be rated by an independent expert unaware of the study hypotheses for fidelity to the therapeutic model using a codebook and form based on Waltz et al. (1993). The effectiveness of the programs will be CONDITION: Anxiety and depression ; Mental and Behavioural Disorders ; Mixed anxiety and depressive disorder PRIMARY OUTCOME: Disorder Severity indicated by the Mean Clinical Severity Rating of all anxiety and mood disorders assessed in the Anxiety and Related Disorders Interview Schedule 5th edition (ADIS‐V) at post‐treatment (i.e., 14 weeks from baseline assessment). INCLUSION CRITERIA: 1. Aged 65 years or older. 2. Primary anxiety and/or unipolar depressive disorder as assessed by the Anxiety and Related Disorders Interview Schedule (ADIS‐V). SECONDARY OUTCOME: ; 1. Disorder Severity indicated by the Mean Clinician’s Severity Rating of all anxiety and mood disorders based on the ADIS‐V 12 months from the start of therapy.; 2. Changes in Symptomatology measured at baseline, 14 weeks from baseline assessment, and 12 months from the start of therapy on the following measures:; 2.1. Geriatric Anxiety Inventory.; 2.2. Geriatric Anxiety Scale.; 2.3. The Geriatric Depression Scale.; 2.4. The Depressive Symptoms Inventory – Suicide Subscale.; 3. Changes in Social Participation measured at baseline, 14 weeks from baseline assessment, and 12 months from the start of therapy on the following measures:; 3.1. De Jong Gierveld Loneliness Scales.; 3.2. The Lubben Social Network Scale.; 3.3. The Bille‐ Brahe Social Support scale.; 4. Cost‐Effectiveness measured at baseline, 14 weeks from baseline assessment, and 12 months from the start of therapy on the following measures:; 4.1. Australian Quality of Life total score.; 4.2. The iMTA Productivity Cost Questionnaire total score.; 4.3. The Australian Community Participation Questionnaire short form total score.; 4.4. The Use of Service Questionnaire total score.; 4.5. Health Resource Use: data will be sourced using a purpose‐built medical cost questionnaire, supplemented with linked data from the NSW Centre for Health Record.; 4.6. Linkage (CHeReL) on Admitted Patient data, Emergency Department data, and Mental Health Ambulatory data, along with the Medicare Benefit Schedule (MBS) and Pharmaceutical Benefit Schedule (PBS) data.;