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

Primary Purpose

Dementia, Cognitive Impairment, Anxiety

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Tech-CBT intervention

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Cognitive Impairment, Anxiety, Cognitive Behavioural Therapy, Technology, Telehealth, Randomized Control Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 moderate to high risk of suicide as identified 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 with major depression as the primary complaint without reported symptoms of anxiety
Persons with comorbid psychiatric conditions

Sites / Locations

Queensland University of Technology
Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services
Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services
The University of QueenslandRecruiting
Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tech-CBT intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in anxiety

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

Secondary Outcome Measures

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)

Change in anxiety

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

Change in worry

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

Change in stress

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

Change in depressive symptoms

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

Change in carer burden

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

Change in carer quality of life

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

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).

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).

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).

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).

Full Information

NCT ID

NCT05528302

First Posted

July 19, 2022

Last Updated

March 8, 2023

Sponsor

The University of Queensland

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

1. Study Identification

Unique Protocol Identification Number

NCT05528302

Brief Title

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

Acronym

Tech-CBT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 20, 2023 (Actual)

Primary Completion Date

May 31, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Queensland

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia, Cognitive Impairment, Anxiety

Keywords

Dementia, Cognitive Impairment, Anxiety, Cognitive Behavioural Therapy, Technology, Telehealth, Randomized Control Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tech-CBT intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Tech-CBT intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in anxiety

Description

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

Time Frame

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 Measure Information:

Title

Change in quality of life

Description

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

Time Frame

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).

Title

Change in anxiety

Description

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

Time Frame

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).

Title

Change in worry

Description

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

Time Frame

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).

Title

Change in stress

Description

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

Time Frame

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).

Title

Change in depressive symptoms

Description

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

Time Frame

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).

Title

Change in carer burden

Description

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

Time Frame

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).

Title

Change in carer quality of life

Description

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

Time Frame

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).

Title

Change in carer depression and anxiety symptoms

Description

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

Time Frame

Post assessment - week 8 (primary). Score ranging between 0 to 126 (lower score indicates better outcomes).

Title

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

Description

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

Time Frame

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).

Title

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

Description

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

Time Frame

Post assessment - week 8 (primary). Score ranging between 0 to 40 (lower score indicates better outcomes).

Title

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

Description

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

Time Frame

Post assessment - week 8 (primary). Score ranging between 0 to 48 (lower score indicates better outcomes).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 moderate to high risk of suicide as identified 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 with major depression as the primary complaint without reported symptoms of anxiety Persons with comorbid psychiatric conditions

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nadeeka Dissanayaka, PhD

Phone

+61733466026

n.dissanayaka@uq.edu.au

First Name & Middle Initial & Last Name or Official Title & Degree

Tiffany Au, BBiomedSc

Phone

+61733465577

t.au@uq.edu.au

Facility Information:

Facility Name

Queensland University of Technology

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4000

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerard Byrne

Phone

+617 3646 1148

gerard.byrne@health.qld.gov.au

First Name & Middle Initial & Last Name & Degree

Gerard Byrne

First Name & Middle Initial & Last Name & Degree

John O'Sullivan

First Name & Middle Initial & Last Name & Degree

Robert Adam

First Name & Middle Initial & Last Name & Degree

Rodney Marsh

Facility Name

Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kanaganayagam Appadurai

Phone

+617 36477111

Kana.Appadurai@health.qld.gov.au

First Name & Middle Initial & Last Name & Degree

Kanaganayagam Appadurai

Facility Name

The University of Queensland

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4072

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadeeka Dissanayaka, PhD

Phone

+617 33466026

n.dissanayaka@uq.edu.au

First Name & Middle Initial & Last Name & Degree

Tiffany Au, BBiomedSc

Phone

+617 33465577

t.au@uq.edu.au

First Name & Middle Initial & Last Name & Degree

Nadeeka Dissanayaka

First Name & Middle Initial & Last Name & Degree

Deborah Brooks

First Name & Middle Initial & Last Name & Degree

Leander Mitchell

First Name & Middle Initial & Last Name & Degree

Nancy Pachana

First Name & Middle Initial & Last Name & Degree

Peter Worthy

First Name & Middle Initial & Last Name & Degree

Syed Keramat

First Name & Middle Initial & Last Name & Degree

Sally Bennett

First Name & Middle Initial & Last Name & Degree

Tracy Comans

First Name & Middle Initial & Last Name & Degree

Mark Chatfield

First Name & Middle Initial & Last Name & Degree

Jacki Liddle

First Name & Middle Initial & Last Name & Degree

Anthony Angwin

First Name & Middle Initial & Last Name & Degree

Kimberley Welsh

First Name & Middle Initial & Last Name & Degree

Teagan King

Facility Name

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

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annette Broome

Phone

+61422101394

Annette.Broome@health.qld.gov.au

First Name & Middle Initial & Last Name & Degree

Joanne Oram

Joanne.Oram@health.qld.gov.au

First Name & Middle Initial & Last Name & Degree

Annette Broome

First Name & Middle Initial & Last Name & Degree

Joanne Oram

First Name & Middle Initial & Last Name & Degree

Alexander Lehn

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data (IPD) collected in this study will not be shared to other researchers.

Learn more about this trial

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

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