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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.
Queensland University of Technology
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services
Brisbane, Queensland, Australia
Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services
Brisbane, Queensland, Australia
The University of Queensland
Brisbane, Queensland, Australia
Change in anxiety
Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID).
Time frame: Post-assessment (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes).
Change in quality of life
Change from baseline in quality of life as measured by the Quality of Life in Alzheimer's Disease (QoL-AD)
Time frame: 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 in anxiety
Change from baseline in anxiety as measured by the Geriatric Anxiety Inventory (GAI)
Time frame: 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 in worry
Change from baseline in worry as measured by the abbreviated version of the Penn State Worry Questionnaire (PSWQ-A).
Time frame: 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 in stress
Change from baseline in stress as measured by the Perceived Stress Scale (PSS-14).
Time frame: 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 in depressive symptoms
Change from baseline in depressive symptoms as measured by the Geriatric Depression Scale (GDS).
Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 15 (lower score indicates better outcomes).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services
Brisbane, Queensland, Australia
Change in carer burden
Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI).
Time frame: 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 in carer quality of life
Change from baseline in carer quality of life as measured by the Assessment of Quality of Life (AQoL).
Time frame: 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 in carer depression and anxiety symptoms
Change from baseline in carer depression and anxiety symptoms as measured by the Depression Anxiety Stress Scales (DASS-21).
Time frame: Post-assessment (~week 8). Score ranging between 0 to 126 (lower score indicates better outcomes).
For people living with Parkinson's Disease, a change in Parkinsonism symptomology
Change from baseline in Parkinsonism symptomology as measured by the Patient Reported Outcomes in Parkinson's Disease (PRO-PD).
Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 3500 (lower score indicates better outcomes).
For people living with Parkinson's Disease, a change in anxiety
Change from baseline in anxiety as measured by the Parkinson's disease Specific Anxiety Inventory (PDSAI).
Time frame: Post-assessment (~week 8). Score ranging between 0 to 40 (lower score indicates better outcomes).
For people living with Parkinson's Disease, a change in anxiety
Change from baseline in anxiety as measured by the Parkinson's Anxiety Scale (PAS).
Time frame: Post-assessment (~week 8). Score ranging between 0 to 48 (lower score indicates better outcomes).