Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment (Tele-CBT)

July 21, 2025 updated by: The University of Queensland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4072
        • The University of Queensland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
People who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions
Behavioral: Cognitive Behavioral Therapy (CBT)
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.
No Intervention: Control
People who are randomised into the control arm will undergo usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety
Time Frame: Post assessment (week 8). Scores 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).
Post assessment (week 8). Scores ranging between 0 to 54 (lower score indicates better outcomes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression
Time Frame: Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes)
Change from baseline in depression as measured by the Geriatric Depression Scale (GDS)
Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes)
Change in quality of life
Time Frame: Post assessment (week 8). Scores 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)
Post assessment (week 8). Scores ranging between 0 to 52 (higher score indicates better outcomes)
Change in carer burden
Time Frame: Post assessment (week 8). Scores ranging between 0-88 (lower score indicates better outcomes)
Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI)
Post assessment (week 8). Scores ranging between 0-88 (lower score indicates better outcomes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Investigators

  • Principal Investigator: Nadeeka Dissanayaka, PhD, The University of Queensland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Actual)

July 16, 2022

Study Completion (Actual)

July 16, 2022

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/17/QRBW/676

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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