Technology-assisted therapy for anxiety in people with cognitive impairment
Technology Assisted and Remotely Delivered Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment: Randomised Controlled Trial
This study is testing a new online therapy program for people with cognitive impairment to see if it helps reduce their anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Locations | 5 sites (Brisbane, Queensland and 4 other locations) |
| Trial ID | NCT05528302 on ClinicalTrials.gov |
What this trial studies
This study evaluates a remotely-delivered, technology-assisted psychotherapy program designed for individuals with cognitive impairment who are experiencing anxiety. It aims to test the efficacy of a modified Cognitive Behavioural Therapy (CBT) package, known as Tech-CBT, which integrates telehealth methods to enhance treatment delivery. The study will also assess the cost-effectiveness, usability, and acceptability of this intervention, along with a process evaluation to inform its implementation in community settings and memory clinics. The ultimate goal is to create a strategic roadmap for improving anxiety treatment in health services.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with mild cognitive impairment or dementia who are experiencing anxiety.
Not a fit: Patients with severe dementia, those unable to communicate, or individuals with major depression as the primary complaint may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide an effective treatment option for anxiety in individuals with cognitive impairment, improving their overall quality of life.
How similar studies have performed: Other studies have shown promise in using technology-assisted therapies for mental health conditions, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brisbane, Queensland and 4 other locations
- Queensland University of Technology — Brisbane, Queensland, Australia (Active_not_recruiting)
- Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services — Brisbane, Queensland, Australia (Recruiting)
- Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services — Brisbane, Queensland, Australia (Not_yet_recruiting)
- The University of Queensland — Brisbane, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services — Brisbane, Queensland, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Nadeeka Dissanayaka, PhD
- Email: n.dissanayaka@uq.edu.au
- Phone: +61733466026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.