DementiaTech-CBTNCT05528302
Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment
A study testing Tech-CBT intervention in people with Dementia and Cognitive Impairment, run by The University of Queensland at 5 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment, Anxiety
- What is being tested?
- Tech-CBT intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesAustralia
- Study dates
- 20 Feb 2023to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Queensland University of Technology
Brisbane, Queensland, 4000
Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services
Brisbane, Queensland, 4029
Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services
Brisbane, Queensland, 4029
The University of Queensland
Brisbane, Queensland, 4072
Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services
Brisbane, Queensland, 4102
About this study
Official title: Technology Assisted and Remotely Delivered Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment: Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Dementia, Cognitive Impairment, Anxiety
- Being tested
- Tech-CBT intervention
- Keywords
- Dementia, Cognitive Impairment, Anxiety, Cognitive Behavioural Therapy, Technology, Telehealth, Randomized Control Trial
- Medical subject headings
- Dementia, Cognitive Dysfunction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tech-CBT interventionOther
The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.
| Study group | Role | What they receive |
|---|---|---|
| Tech-CBT intervention | Experimental | Participants allocated to the Tech-CBT intervention group will attend six telehealth videoconferencing sessions - 1 session per week over 6 weeks. Each session will last between 60 to 90 minutes and will be facilitated by a trained therapist. During each session, the participant will learn and practice different psychotherapy techniques. The participant will be encouraged to practice these skills between sessions with the technology provided, either on their own or with the help of their support person. Receives: Other: Tech-CBT intervention |
| Control | No intervention | Participants allocated to the Control group will receive usual care (i.e., no treatment for anxiety) and a mid-point check-in phone call/video call/email (depending on their preference) from the study team approximately 3 weeks after completing the initial questionnaires. This mid-point check-in is to identify whether there have been any changes to their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID).
Measured: Post-assessment (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes).
Secondary outcomes (11)
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)
Measured: 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 in anxiety
Change from baseline in anxiety as measured by the Geriatric Anxiety Inventory (GAI)
Measured: 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 in worry
Change from baseline in worry as measured by the abbreviated version of the Penn State Worry Questionnaire (PSWQ-A).
Measured: 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 in stress
Change from baseline in stress as measured by the Perceived Stress Scale (PSS-14).
Measured: 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 in depressive symptoms
Change from baseline in depressive symptoms as measured by the Geriatric Depression Scale (GDS).
Measured: 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 in carer burden
Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI).
Measured: 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 in carer quality of life
Change from baseline in carer quality of life as measured by the Assessment of Quality of Life (AQoL).
Measured: 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 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).
Measured: Post-assessment (~week 8). Score ranging between 0 to 126 (lower score indicates better outcomes).
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).
Measured: Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 3500 (lower score indicates better outcomes).
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).
Measured: Post-assessment (~week 8). Score ranging between 0 to 40 (lower score indicates better outcomes).
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).
Measured: Post-assessment (~week 8). Score ranging between 0 to 48 (lower score indicates better outcomes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start20 Feb 2023
- Primary completion22 Oct 2025
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Future Fund, Metro South Hospital and Health Services, Metro North Hospital and Health Services, Queensland University of Technology, TalkVia, Lions District 201Q3
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528302
- Sponsor's protocol ID
- HREC/2022/QRBW/83925
- Acronym
- Tech-CBT
- Status last verified
- Jan 2026
- First submitted
- 19 Jul 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected in this study will not be shared to other researchers.
Publications
Dissanayaka N, Brooks D, Worthy P, Mitchell L, Pachana NA, Byrne G, Keramat SA, Comans T, Bennett S, Liddle J, Chatfield MD, Broome A, Oram J, Appadurai K, Beattie E, Au T, King T, Welsh K, Pietsch A. A single-blind, parallel-group randomised trial of a Technology-assisted and remotely delivered Cognitive Behavioural Therapy intervention (Tech-CBT) versus usual care to reduce anxiety in people with mild cognitive impairment and dementia: study protocol for a randomised trial. Trials. 2023 Jun 20;24(1):420. doi: 10.1186/s13063-023-07381-2.
PubMed 37340492
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted and Remotely Delivered Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05528302
- Acronym / sponsor ID
- Tech-CBT / HREC/2022/QRBW/83925
- Conditions
- Dementia, Cognitive Impairment, Anxiety
- Keywords
- Dementia, Cognitive Impairment, Anxiety, Cognitive Behavioural Therapy, Technology, Telehealth, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Medical Research Future Fund, Metro South Hospital and Health Services, Metro North Hospital and Health Services, Queensland University of Technology, TalkVia, Lions District 201Q3
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tech-CBT intervention | Experimental | Other: Tech-CBT interventionParticipants allocated to the Tech-CBT intervention group will attend six telehealth videoconferencing sessions - 1 session per week over 6 weeks. Each session will last between 60 to 90 minutes and will be facilitated by a trained therapist. During each session, the participant will learn and practice different psychotherapy techniques. The participant will be encouraged to practice these skills between sessions with the technology provided, either on their own or with the help of their support person. |
| Control | No intervention | –Participants allocated to the Control group will receive usual care (i.e., no treatment for anxiety) and a mid-point check-in phone call/video call/email (depending on their preference) from the study team approximately 3 weeks after completing the initial questionnaires. This mid-point check-in is to identify whether there have been any changes to their usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tech-CBT interventionThe Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods. | Other | Tech-CBT intervention |
Primary outcome
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).
11 secondary outcomes
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 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 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 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 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 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 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 in carer depression and anxiety symptoms
Time frame: Post-assessment (~week 8). Score ranging between 0 to 126 (lower score indicates better outcomes).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 37340492Dissanayaka N, Brooks D, Worthy P, Mitchell L, Pachana NA, Byrne G, Keramat SA, Comans T, Bennett S, Liddle J, Chatfield MD, Broome A, Oram J, Appadurai K, Beattie E, Au T, King T, Welsh K, Pietsch A. A single-blind, parallel-group randomised trial of a Technology-assisted and remotely delivered Cognitive Behavioural Therapy intervention (Tech-CBT) versus usual care to reduce anxiety in people with mild cognitive impairment and dementia: study protocol for a randomised trial. Trials. 2023 Jun 20;24(1):420. doi: 10.1186/s13063-023-07381-2.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected in this study will not be shared to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tech-CBT intervention in people with Dementia and Cognitive Impairment, run by The University of Queensland at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.