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

Anxiety Clinical Trial

— Tech-CBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528302
• Other study ID #: HREC/2022/QRBW/83925
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia

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).