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| Name | Class |
|---|---|
| Medical Research Future Fund | OTHER |
| Metro South Hospital and Health Services | UNKNOWN |
| Metro North Hospital and Health Services | UNKNOWN |
| Queensland University of Technology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tech-CBT intervention | Experimental | 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. |
|
| Control | No Intervention | Participants allocated to the Control group will receive usual care (i.e., no treatment for anxiety) and a mid-point check-in phone call/video call/email (depending on their preference) from the study team approximately 3 weeks after completing the initial questionnaires. This mid-point check-in is to identify whether there have been any changes to their usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tech-CBT intervention | Other | The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety | Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID). | Post-assessment (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queensland University of Technology | Brisbane | Queensland | 4000 | Australia | ||
| Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37340492 | Derived | Dissanayaka N, Brooks D, Worthy P, Mitchell L, Pachana NA, Byrne G, Keramat SA, Comans T, Bennett S, Liddle J, Chatfield MD, Broome A, Oram J, Appadurai K, Beattie E, Au T, King T, Welsh K, Pietsch A. A single-blind, parallel-group randomised trial of a Technology-assisted and remotely delivered Cognitive Behavioural Therapy intervention (Tech-CBT) versus usual care to reduce anxiety in people with mild cognitive impairment and dementia: study protocol for a randomised trial. Trials. 2023 Jun 20;24(1):420. doi: 10.1186/s13063-023-07381-2. |
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Individual participant data (IPD) collected in this study will not be shared to other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2026 | Jan 30, 2026 |
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| OTHER |
| TalkVia | UNKNOWN |
| Lions District 201Q3 | UNKNOWN |
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Change from baseline in anxiety as measured by the Geriatric Anxiety Inventory (GAI) |
| 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). | 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). | 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). | 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 in carer burden | Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI). | 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). | 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). | 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). | 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). | 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). | Post-assessment (~week 8). Score ranging between 0 to 48 (lower score indicates better outcomes). |
| Brisbane |
| Queensland |
| 4029 |
| Australia |
| Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services | Brisbane | Queensland | 4029 | Australia |
| The University of Queensland | Brisbane | Queensland | 4072 | Australia |
| Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services | Brisbane | Queensland | 4102 | Australia |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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