Anxiety, Cognitive Impairment, Dementia
Conditions
Keywords
Dementia, Cognitive Impairment, Anxiety, Cognitive Behavioural Therapy, Technology, Telehealth, Randomized Control Trial
Brief summary
This study is a randomized controlled trial (RCT) of a remotely-delivered, technology-assisted psychotherapy program, supported by an innovative software platform for people with cognitive impairment experiencing anxiety.
Detailed description
Despite harmful health and economic consequences, anxiety is a vexing issue in persons with cognitive impairment with inadequate treatment options. What is needed currently is a digital technology option for treating anxiety in persons with cognitive impairment that can be rigorously evaluated and implemented. The objective of the study is to test the efficacy of a newly modified psychotherapy package (Tech-CBT), which incorporates Cognitive Behaviour Therapy (CBT) methods, assisted with technology and telehealth for persons with cognitive impairment experiencing anxiety. This project will also investigate the cost-effectiveness, usability and acceptability of Tech-CBT to enhance delivery of anxiety treatment for people with cognitive impairment. A process evaluation will inform its implementation in the community and memory clinics, and will recommend a strategic translational roadmap to enhance delivery of anxiety treatment in health services with a broad reach.
Interventions
OTHERTech-CBT intervention
The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.
Sponsors
The University of Queensland
Medical Research Future Fund
Metro South Hospital and Health Services
Metro North Hospital and Health Services
Queensland University of Technology
TalkVia
Lions District 201Q3
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persons aged 18 years or over * Persons with a diagnosis of mild cognitive impairment (MCI) or dementia of any aetiology based on a previous diagnosis by a clinician or scoring above threshold (≤32; MCI ≤32 and dementia ≤27) for cognitive impairment in the Modified Telephone Interview for Cognitive Impairment (TICS-M). * Screening positive for anxiety (scoring ≥9 on Geriatric Anxiety Inventory, GAI), and/or subjective complaints of anxiety and/ or clinician diagnosis of a current anxiety disorder and screening positive for anxiety using the Rating Anxiety in Dementia scale (scoring ≥11 on RAID)
Exclusion criteria
* Persons with severe dementia * Persons unable to communicate or complete questionnaires * Persons who have a current risk of suicide within the last month as determined by the study clinical expert team. * Persons with major depression as the primary complaint without reported symptoms of anxiety * Persons with comorbid psychiatric conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety | Post-assessment (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes). | Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 52 (higher score indicates better outcomes). | Change from baseline in quality of life as measured by the Quality of Life in Alzheimer's Disease (QoL-AD) |
| Change in anxiety | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 20 (lower score indicates better outcomes). | Change from baseline in anxiety as measured by the Geriatric Anxiety Inventory (GAI) |
| Change in worry | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 8 to 40 (lower score indicates better outcomes). | Change from baseline in worry as measured by the abbreviated version of the Penn State Worry Questionnaire (PSWQ-A). |
| Change in stress | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 56 (lower score indicates better outcomes). | Change from baseline in stress as measured by the Perceived Stress Scale (PSS-14). |
| Change in depressive symptoms | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 15 (lower score indicates better outcomes). | Change from baseline in depressive symptoms as measured by the Geriatric Depression Scale (GDS). |
| Change in carer burden | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 88 (lower score indicates better outcomes). | Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI). |
| Change in carer quality of life | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 20 to 99 (lower score indicates better outcomes). | Change from baseline in carer quality of life as measured by the Assessment of Quality of Life (AQoL). |
| Change in carer depression and anxiety symptoms | Post-assessment (~week 8). Score ranging between 0 to 126 (lower score indicates better outcomes). | Change from baseline in carer depression and anxiety symptoms as measured by the Depression Anxiety Stress Scales (DASS-21). |
| For people living with Parkinson's Disease, a change in Parkinsonism symptomology | Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 3500 (lower score indicates better outcomes). | Change from baseline in Parkinsonism symptomology as measured by the Patient Reported Outcomes in Parkinson's Disease (PRO-PD). |
| For people living with Parkinson's Disease, a change in anxiety | Post-assessment (~week 8). Score ranging between 0 to 40 (lower score indicates better outcomes). | Change from baseline in anxiety as measured by the Parkinson's disease Specific Anxiety Inventory (PDSAI). |
Countries
Australia
Outcome results
None listed