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This project will pilot a tailored Cognitive Behavioral Therapy (CBT) intervention delivered via telehealth videoconferencing (Tele-CBT) to reduce anxiety in people living with cognitive impairment. A process evaluation will inform its feasibility and implementation in the community nation-wide.
Anxiety is a pre-existing mental health issue in older persons with cognitive impairment (includes people with mild cognitive impairment (MCI) and dementia), with considerably high prevalence (14%) as compared to older persons in the general population (3%). Anxiety results in accelerated cognitive decline, increased aggressive behaviours, and even an increased risk of suicide. Anxiety also negatively influences quality of life (QoL) of the individual with cognitive impairment and their care partner, increases early institutionalisation, and amplifies economic burden.
The Tele-CBT package used in this study is a modification of existing manualised psychotherapeutic interventions for treatment of anxiety in people with Parkinson's disease and older adults with cognitive impairment. This new package incorporates techniques tailored to reduce anxiety in people with cognitive impairment, including symptom monitoring. The interventions will include various psychological techniques aimed at reducing anxiety and stress. The intervention consists of 6 weekly psychotherapy sessions. Each therapy session lasts between 30-60 minutes, depending on the participants' capacity to actively participate in session and on their cognitive functioning (e.g. complex attention, executive function). Support persons will be invited and instructed to actively engage in the therapy sessions as well as in between-session home tasks to support the person with cognitive impairment. These techniques will be facilitated via the use of non-immersive videos in telehealth videoconferencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | People who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions |
|
| Control | No Intervention | People who are randomised into the control arm will undergo usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | The CBT intervention includes 6 sessions via video-conferencing that has been tailored for people living with cognitive impairment. The sessions incorporate the use of psychoeducation and relaxation videos to improve home-based practise for long-term outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety | Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID). | Post assessment (week 8). Scores ranging between 0 to 54 (lower score indicates better outcomes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression | Change from baseline in depression as measured by the Geriatric Depression Scale (GDS) | Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes) |
| Change in quality of life |
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Inclusion Criteria:
Exclusion Criteria:
Entry into the study:
Study entry will be determined by discussions with the core investigator team consisting of clinicians and experienced researchers.
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| Name | Affiliation | Role |
|---|---|---|
| Nadeeka Dissanayaka, PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Queensland | Brisbane | Queensland | 4072 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30536144 | Background | Kuring JK, Mathias JL, Ward L. Prevalence of Depression, Anxiety and PTSD in People with Dementia: a Systematic Review and Meta-Analysis. Neuropsychol Rev. 2018 Dec;28(4):393-416. doi: 10.1007/s11065-018-9396-2. Epub 2018 Dec 7. | |
| 25685141 | Background | Banks SJ, Raman R, He F, Salmon DP, Ferris S, Aisen P, Cummings J. The Alzheimer's disease cooperative study prevention instrument project: longitudinal outcome of behavioral measures as predictors of cognitive decline. Dement Geriatr Cogn Dis Extra. 2014 Dec 18;4(3):509-16. doi: 10.1159/000357775. eCollection 2014 Sep-Dec. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Participants will be randomised (1:1 ratio) to either the Tele-CBT intervention or usual care (Control) arm.
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Assessors will be blinded to what arm the participant is allocated to.
|
Change from baseline in quality of life as measured by the Quality of Life in Alzheimer's Disease (QoL-AD)
| Post assessment (week 8). Scores ranging between 0 to 52 (higher 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). Scores ranging between 0-88 (lower score indicates better outcomes) |
| 11281317 | Background | Ferretti L, McCurry SM, Logsdon R, Gibbons L, Teri L. Anxiety and Alzheimer's disease. J Geriatr Psychiatry Neurol. 2001 Spring;14(1):52-8. doi: 10.1177/089198870101400111. |
| 22055973 | Background | Seyfried LS, Kales HC, Ignacio RV, Conwell Y, Valenstein M. Predictors of suicide in patients with dementia. Alzheimers Dement. 2011 Nov;7(6):567-73. doi: 10.1016/j.jalz.2011.01.006. |
| 31752633 | Background | Poon E. A Systematic Review and Meta-Analysis of Dyadic Psychological Interventions for BPSD, Quality of Life and/or Caregiver Burden in Dementia or MCI. Clin Gerontol. 2022 Jul-Sep;45(4):777-797. doi: 10.1080/07317115.2019.1694117. Epub 2019 Nov 22. |
| 31646432 | Background | Konnopka A, Konig H. Economic Burden of Anxiety Disorders: A Systematic Review and Meta-Analysis. Pharmacoeconomics. 2020 Jan;38(1):25-37. doi: 10.1007/s40273-019-00849-7. |
| 38551852 | Derived | Pacas Fronza G, Mitchell LK, Pachana NA, Byrne GJ, Liddle J, Yang J, Brooks D, Au T, Pourzinal D, Worthy P, Comans T, Beattie E, Bennett S, Russell T, Dissanayaka NN. Telehealth Cognitive Behavior Therapy to Reduce Anxiety in People Living with Cognitive Impairment: A Randomized Feasibility Pilot Study. Clin Gerontol. 2025 Jul-Sep;48(4):684-698. doi: 10.1080/07317115.2024.2336187. Epub 2024 Mar 29. |