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PsychotherapyTele-CBTNCT05030285

Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment

A study testing Cognitive Behavioral Therapy (CBT) in people with Psychotherapy and Cognitive Impairment, run by The University of Queensland at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project will pilot a tailored Cognitive Behavioral Therapy (CBT) intervention delivered via telehealth videoconferencing (Tele-CBT) to reduce anxiety in people living with cognitive impairment. A process evaluation will inform its feasibility and implementation in the community nation-wide. Read more about this study

Who is it for?
Any age
Conditions the study is for
Psychotherapy, Cognitive Impairment, Anxiety
What is being tested?
Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteAustralia
Study dates
21 Sep 2021to 16 Jul 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 screening positive for anxiety (scoring ≥9 in the Geriatric Anxiety Inventory, GAI) or reports subjective complaints of anxiety

Who cannot join

  • Persons with severe dementia
  • Persons who are unable to communicate or complete questionnaires
  • Persons who are at high risk of suicide as identified by by the University of Queensland Suicidal Risk Assessment administered at the UQ Psychology clinic which has been modified for use by the Dementia and Neuro Mental Health Research Unit
  • Persons who have major depression as the primary complaint without reported symptoms of anxiety.
  • Persons on existing anxiolytics or antidepressants who have not been on a stable dose for at least 12 weeks before starting the trial and are unable to maintain the same dose for the duration of the trial. Changes to medication will be checked at each therapy and assessment session.
  • Persons who are undergoing psychological therapy or will undergo psychological therapy over the trial duration.
  • Entry into the study:
  • Study entry will be determined by discussions with the core investigator team consisting of clinicians and experienced researchers.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The University of Queensland

    Brisbane, Queensland, 4072

Other trials in Australia

About this study

This project will pilot a tailored Cognitive Behavioral Therapy (CBT) intervention delivered via telehealth videoconferencing (Tele-CBT) to reduce anxiety in people living with cognitive impairment. A process evaluation will inform its feasibility and implementation in the community nation-wide.

Read the detailed description

Anxiety is a pre-existing mental health issue in older persons with cognitive impairment (includes people with mild cognitive impairment (MCI) and dementia), with considerably high prevalence (14%) as compared to older persons in the general population (3%). Anxiety results in accelerated cognitive decline, increased aggressive behaviours, and even an increased risk of suicide. Anxiety also negatively influences quality of life (QoL) of the individual with cognitive impairment and their care partner, increases early institutionalisation, and amplifies economic burden.

The Tele-CBT package used in this study is a modification of existing manualised psychotherapeutic interventions for treatment of anxiety in people with Parkinson's disease and older adults with cognitive impairment. This new package incorporates techniques tailored to reduce anxiety in people with cognitive impairment, including symptom monitoring. The interventions will include various psychological techniques aimed at reducing anxiety and stress. The intervention consists of 6 weekly psychotherapy sessions. Each therapy session lasts between 30-60 minutes, depending on the participants' capacity to actively participate in session and on their cognitive functioning (e.g. complex attention, executive function). Support persons will be invited and instructed to actively engage in the therapy sessions as well as in between-session home tasks to support the person with cognitive impairment. These techniques will be facilitated via the use of non-immersive videos in telehealth videoconferencing.

Being tested
Cognitive Behavioral Therapy (CBT)
Keywords
Psychotherapy, Cognitive Impairments, Anxiety
Medical subject headings
Cognitive Dysfunction, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy (CBT)Behavioural

    The CBT intervention includes 6 sessions via video-conferencing that has been tailored for people living with cognitive impairment. The sessions incorporate the use of psychoeducation and relaxation videos to improve home-based practise for long-term outcomes.

Study groups in NCT05030285
Study groupRoleWhat they receive
InterventionExperimentalPeople who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions
Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
ControlNo interventionPeople who are randomised into the control arm will undergo usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in anxiety

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

    Measured: Post assessment (week 8). Scores ranging between 0 to 54 (lower score indicates better outcomes)

Secondary outcomes (3)

  1. Change in depression

    Change from baseline in depression as measured by the Geriatric Depression Scale (GDS)

    Measured: Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes)

  2. 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). Scores ranging between 0 to 52 (higher score indicates better outcomes)

  3. Change in carer burden

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

    Measured: Post assessment (week 8). Scores ranging between 0-88 (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.

  1. First posted1 Sep 2021
  2. Study start21 Sep 2021
  3. Primary completion16 Jul 2022
  4. Study completion16 Jul 2022

Resources

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
Model description
Participants will be randomised (1:1 ratio) to either the Tele-CBT intervention or usual care (Control) arm.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05030285
Sponsor's protocol ID
HREC/17/QRBW/676
Acronym
Tele-CBT
Status last verified
Jul 2025
First submitted
26 Aug 2021
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kuring JK, Mathias JL, Ward L. Prevalence of Depression, Anxiety and PTSD in People with Dementia: a Systematic Review and Meta-Analysis. Neuropsychol Rev. 2018 Dec;28(4):393-416. doi: 10.1007/s11065-018-9396-2. Epub 2018 Dec 7.

    PubMed 30536144

  • Banks SJ, Raman R, He F, Salmon DP, Ferris S, Aisen P, Cummings J. The Alzheimer's disease cooperative study prevention instrument project: longitudinal outcome of behavioral measures as predictors of cognitive decline. Dement Geriatr Cogn Dis Extra. 2014 Dec 18;4(3):509-16. doi: 10.1159/000357775. eCollection 2014 Sep-Dec.

    PubMed 25685141

  • Ferretti L, McCurry SM, Logsdon R, Gibbons L, Teri L. Anxiety and Alzheimer's disease. J Geriatr Psychiatry Neurol. 2001 Spring;14(1):52-8. doi: 10.1177/089198870101400111.

    PubMed 11281317

  • Seyfried LS, Kales HC, Ignacio RV, Conwell Y, Valenstein M. Predictors of suicide in patients with dementia. Alzheimers Dement. 2011 Nov;7(6):567-73. doi: 10.1016/j.jalz.2011.01.006.

    PubMed 22055973

  • Poon E. A Systematic Review and Meta-Analysis of Dyadic Psychological Interventions for BPSD, Quality of Life and/or Caregiver Burden in Dementia or MCI. Clin Gerontol. 2022 Jul-Sep;45(4):777-797. doi: 10.1080/07317115.2019.1694117. Epub 2019 Nov 22.

    PubMed 31752633

  • Konnopka A, Konig H. Economic Burden of Anxiety Disorders: A Systematic Review and Meta-Analysis. Pharmacoeconomics. 2020 Jan;38(1):25-37. doi: 10.1007/s40273-019-00849-7.

    PubMed 31646432

  • Pacas Fronza G, Mitchell LK, Pachana NA, Byrne GJ, Liddle J, Yang J, Brooks D, Au T, Pourzinal D, Worthy P, Comans T, Beattie E, Bennett S, Russell T, Dissanayaka NN. Telehealth Cognitive Behavior Therapy to Reduce Anxiety in People Living with Cognitive Impairment: A Randomized Feasibility Pilot Study. Clin Gerontol. 2025 Jul-Sep;48(4):684-698. doi: 10.1080/07317115.2024.2336187. Epub 2024 Mar 29.

    PubMed 38551852

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy (CBT) in people with Psychotherapy and Cognitive Impairment, run by The University of Queensland at 1 site 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 2 inclusion and 8 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 (week 8). Scores 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 NCT05030285, which also lists 7 linked publications.

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 24 Jul 2025.

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