Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment (Tech-CBT)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Dementia; Anxiety
• Intervention / Treatment: Other: Tech-CBT intervention

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadeeka Dissanayaka, PhD; Phone Number: +61733466026; Email: n.dissanayaka@uq.edu.au
• Study Contact Backup: Name: Tiffany Au, BBiomedSc; Phone Number: +61733465577; Email: t.au@uq.edu.au

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4072
      • Recruiting
      • The University of Queensland
      • Contact: Nadeeka Dissanayaka, PhD; Phone Number: +617 33466026; Email: n.dissanayaka@uq.edu.au
      • Contact: Tiffany Au, BBiomedSc; Phone Number: +617 33465577; Email: t.au@uq.edu.au
      • Principal Investigator: Nadeeka Dissanayaka
      • Sub-Investigator: Deborah Brooks
      • Sub-Investigator: Leander Mitchell
      • Sub-Investigator: Nancy Pachana
      • Sub-Investigator: Peter Worthy
      • Sub-Investigator: Syed Keramat
      • Sub-Investigator: Sally Bennett
      • Sub-Investigator: Tracy Comans
      • Sub-Investigator: Mark Chatfield
      • Sub-Investigator: Jacki Liddle
      • Sub-Investigator: Anthony Angwin
      • Sub-Investigator: Kimberley Welsh
      • Sub-Investigator: Teagan King
    • Brisbane, Queensland, Australia, 4000
      • Active, not recruiting
      • Queensland University of Technology
    • Brisbane, Queensland, Australia, 4029
      • Not yet recruiting
      • Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services
      • Contact: Kanaganayagam Appadurai; Phone Number: +617 36477111; Email: Kana.Appadurai@health.qld.gov.au
      • Principal Investigator: Kanaganayagam Appadurai
    • Brisbane, Queensland, Australia, 4102
      • Not yet recruiting
      • Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services
      • Contact: Annette Broome; Phone Number: +61422101394; Email: Annette.Broome@health.qld.gov.au
      • Contact: Joanne Oram; Email: Joanne.Oram@health.qld.gov.au
      • Principal Investigator: Annette Broome
      • Sub-Investigator: Joanne Oram
      • Sub-Investigator: Alexander Lehn
    • Brisbane, Queensland, Australia, 4029
      • Recruiting
      • Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services
      • Contact: Gerard Byrne; Phone Number: +617 3646 1148; Email: gerard.byrne@health.qld.gov.au
      • Principal Investigator: Gerard Byrne
      • Sub-Investigator: John O'Sullivan
      • Sub-Investigator: Robert Adam
      • Sub-Investigator: Rodney Marsh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).
• Persons who reports subjective complaints of anxiety and/or screens positive for anxiety on either or all of the following measures: Geriatric Anxiety Inventory (GAI) and Rating Anxiety in Dementia Scale.

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tech-CBT intervention; 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.	Other: Tech-CBT intervention; The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety	Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID).	Post assessment - week 8 (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Post assessment - week 8 (primary), 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)	Post assessment - week 8 (primary), 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).	Post assessment - week 8 (primary), 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).	Post assessment - week 8 (primary), 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).	Post assessment - week 8 (primary), 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).	Post assessment - week 8 (primary), 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).	Post assessment - week 8 (primary), 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).	Post assessment - week 8 (primary). 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).	Post assessment - week 8 (primary), 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).	Post assessment - week 8 (primary). 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).	Post assessment - week 8 (primary). Score ranging between 0 to 48 (lower score indicates better outcomes).

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Cognitive Impairment; Dementia; Telehealth; Cognitive Behavioural Therapy; Randomized Control Trial; Technology
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Anxiety Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: HREC/2022/QRBW/83925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) collected in this study will not be shared to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No