Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment
- Conditions
- DementiaCognitive ImpairmentAnxiety
- Interventions
- Other: Tech-CBT intervention
- Registration Number
- NCT05528302
- Lead Sponsor
- The University of Queensland
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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).
- Persons who reports subjective complaints of anxiety and/or screens positive for anxiety on either or all of the following measures: Geriatric Anxiety Inventory (GAI) and Rating Anxiety in Dementia Scale.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tech-CBT intervention Tech-CBT intervention Participants allocated to the Tech-CBT intervention group will attend six telehealth videoconferencing sessions - 1 session per week over 6 weeks. Each session will last between 60 to 90 minutes and will be facilitated by a trained therapist. During each session, the participant will learn and practice different psychotherapy techniques. The participant will be encouraged to practice these skills between sessions with the technology provided, either on their own or with the help of their support person.
- Primary Outcome Measures
Name Time Method Change in anxiety Post assessment - week 8 (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 Outcome Measures
Name Time Method Change in quality of life Post assessment - week 8 (primary), 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 worry Post assessment - week 8 (primary), 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).
For people living with Parkinson's Disease, a change in Parkinsonism symptomology Post assessment - week 8 (primary), 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).
Change in depressive symptoms Post assessment - week 8 (primary), 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 quality of life Post assessment - week 8 (primary), 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 (primary). 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 anxiety Post assessment - week 8 (primary). Score ranging between 0 to 48 (lower score indicates better outcomes). Change from baseline in anxiety as measured by the Parkinson's Anxiety Scale (PAS).
Change in anxiety Post assessment - week 8 (primary), 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 stress Post assessment - week 8 (primary), 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 carer burden Post assessment - week 8 (primary), 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).
Trial Locations
- Locations (5)
Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services
🇦🇺Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services
🇦🇺Brisbane, Queensland, Australia
The University of Queensland
🇦🇺Brisbane, Queensland, Australia
Queensland University of Technology
🇦🇺Brisbane, Queensland, Australia
Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services
🇦🇺Brisbane, Queensland, Australia