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NCT Number: NCT05528302

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dementia Anxiety Anxiety Disorders Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services, Brisbane, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tech-CBT intervention

Other

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

Primary outcomes

  1. Change in anxiety

    Time frame: Post-assessment (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes).

    Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID).

Secondary outcomes

  1. Change in quality of life

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 52 (higher score indicates better outcomes).

    Change from baseline in quality of life as measured by the Quality of Life in Alzheimer's Disease (QoL-AD)

  2. Change in anxiety

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 20 (lower score indicates better outcomes).

    Change from baseline in anxiety as measured by the Geriatric Anxiety Inventory (GAI)

  3. Change in worry

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 8 to 40 (lower score indicates better outcomes).

    Change from baseline in worry as measured by the abbreviated version of the Penn State Worry Questionnaire (PSWQ-A).

  4. Change in stress

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 56 (lower score indicates better outcomes).

    Change from baseline in stress as measured by the Perceived Stress Scale (PSS-14).

  5. Change in depressive symptoms

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 15 (lower score indicates better outcomes).

    Change from baseline in depressive symptoms as measured by the Geriatric Depression Scale (GDS).

  6. Change in carer burden

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 88 (lower score indicates better outcomes).

    Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI).

  7. Change in carer quality of life

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 20 to 99 (lower score indicates better outcomes).

    Change from baseline in carer quality of life as measured by the Assessment of Quality of Life (AQoL).

  8. Change in carer depression and anxiety symptoms

    Time frame: Post-assessment (~week 8). Score ranging between 0 to 126 (lower score indicates better outcomes).

    Change from baseline in carer depression and anxiety symptoms as measured by the Depression Anxiety Stress Scales (DASS-21).

  9. For people living with Parkinson's Disease, a change in Parkinsonism symptomology

    Time frame: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 3500 (lower score indicates better outcomes).

    Change from baseline in Parkinsonism symptomology as measured by the Patient Reported Outcomes in Parkinson's Disease (PRO-PD).

  10. For people living with Parkinson's Disease, a change in anxiety

    Time frame: Post-assessment (~week 8). Score ranging between 0 to 40 (lower score indicates better outcomes).

    Change from baseline in anxiety as measured by the Parkinson's disease Specific Anxiety Inventory (PDSAI).

  11. For people living with Parkinson's Disease, a change in anxiety

    Time frame: Post-assessment (~week 8). Score ranging between 0 to 48 (lower score indicates better outcomes).

    Change from baseline in anxiety as measured by the Parkinson's Anxiety Scale (PAS).

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • Lions District 201Q3
  • Medical Research Future Fund
  • Metro North Hospital and Health Services
  • Metro South Hospital and Health Services
  • Queensland University of Technology
  • TalkVia

Registry information

Official study title

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

Acronym: Tech-CBT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 6, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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