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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05528302
Other study ID # HREC/2022/QRBW/83925
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date May 31, 2025

Study information

Verified date August 2023
Source The University of Queensland
Contact Nadeeka Dissanayaka, PhD
Phone +61733466026
Email n.dissanayaka@uq.edu.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 70
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Intervention

Other:
Tech-CBT intervention
The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.

Locations

Country Name City State
Australia Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services Brisbane Queensland
Australia 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

Sponsors (7)

Lead Sponsor Collaborator
The University of Queensland Lions District 201Q3, Medical Research Future Fund, Metro North Hospital and Health Services, Metro South Hospital and Health Services, Queensland University of Technology, TalkVia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
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