Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Technology Assisted and Remotely Delivered Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment: Randomised Controlled Trial

Conditions
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Dementia, Cognitive Impairment, Anxiety

Intervention / Treatment
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* Other: Tech-CBT intervention


Participation Criteria
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Eligibility Criteria
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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). 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. Exclusion Criteria: Persons with severe dementia Persons unable to communicate or complete questionnaires Persons who have a moderate to high risk of suicide as identified by the University of Queensland Suicidal Risk Assessment administered at the UQ Psychology clinic which has been modified for use by the Dementia and Neuro Mental Health Research Unit Persons with major depression as the primary complaint without reported symptoms of anxiety Persons with comorbid psychiatric conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tech-CBT intervention<br>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. | Other: Tech-CBT intervention<br>* The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes). | 

Secondary Outcome Measures

| Outcome Measure | 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 (primary), 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) | 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 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 (primary), 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 (primary), 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 (primary), 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 (primary), 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 (primary), 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 (primary). 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 (primary), 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 (primary). 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 (primary). Score ranging between 0 to 48 (lower score indicates better outcomes). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Cognitive Impairment, Anxiety, Cognitive Behavioural Therapy, Technology, Telehealth, Randomized Control Trial