Clinical trial NCT05528302: Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment
Official title: Technology Assisted and Remotely Delivered Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Cognitive Impairment
Anxiety
Keywords: Dementia
Cognitive Impairment
Anxiety
Cognitive Behavioural Therapy
Technology
Telehealth
Randomized Control Trial
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Medical Research Future Fund
name: Metro South Hospital and Health Services
name: Metro North Hospital and Health Services
name: Queensland University of Technology
name: TalkVia
name: Lions District 201Q3
First posted: 2022-09-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).
* Screening positive for anxiety (scoring ≥9 on Geriatric Anxiety Inventory, GAI), and/or subjective complaints of anxiety and/ or clinician diagnosis of a current anxiety disorder and screening positive for anxiety using the Rating Anxiety in Dementia scale (scoring ≥11 on RAID)

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

Primary outcomes:
measure: Change in anxiety
timeFrame: 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 outcomes:
measure: Change in quality of life
timeFrame: 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).
measure: Change in anxiety
timeFrame: 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).
measure: Change in worry
timeFrame: 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).
measure: Change in stress
timeFrame: 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).
measure: Change in depressive symptoms
timeFrame: 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).
measure: Change in carer burden
timeFrame: 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).
measure: Change in carer quality of life
timeFrame: 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).
measure: Change in carer depression and anxiety symptoms
timeFrame: Post assessment - week 8 (primary). Score ranging between 0 to 126 (lower score indicates better outcomes).
measure: For people living with Parkinson's Disease, a change in Parkinsonism symptomology
timeFrame: 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).
measure: For people living with Parkinson's Disease, a change in anxiety
timeFrame: Post assessment - week 8 (primary). Score ranging between 0 to 40 (lower score indicates better outcomes).
measure: For people living with Parkinson's Disease, a change in anxiety
timeFrame: Post assessment - week 8 (primary). Score ranging between 0 to 48 (lower score indicates better outcomes).
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Queensland University of Technology
state: Queensland
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services
state: Queensland
city: Brisbane
country: Australia
facility: Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services
state: Queensland
city: Brisbane
country: Australia
facility: The University of Queensland
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services
state: Queensland
Study officials:
References: