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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05528302




Registration number
NCT05528302
Ethics application status
Date submitted
19/07/2022
Date registered
6/09/2022
Date last updated
27/09/2024

Titles & IDs
Public title
Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment
Scientific title
Technology Assisted and Remotely Delivered Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment: Randomised Controlled Trial
Secondary ID [1] 0 0
HREC/2022/QRBW/83925
Universal Trial Number (UTN)
Trial acronym
Tech-CBT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Cognitive Impairment 0 0
Anxiety 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Tech-CBT intervention

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.

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.


Other interventions: Tech-CBT intervention
The Tech-CBT intervention is a manualised package that incorporates Cognitive Behavioural Therapy methods.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in anxiety
Timepoint [1] 0 0
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 [1] 0 0
Change in quality of life
Timepoint [1] 0 0
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).
Secondary outcome [2] 0 0
Change in anxiety
Timepoint [2] 0 0
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).
Secondary outcome [3] 0 0
Change in worry
Timepoint [3] 0 0
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).
Secondary outcome [4] 0 0
Change in stress
Timepoint [4] 0 0
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).
Secondary outcome [5] 0 0
Change in depressive symptoms
Timepoint [5] 0 0
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).
Secondary outcome [6] 0 0
Change in carer burden
Timepoint [6] 0 0
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).
Secondary outcome [7] 0 0
Change in carer quality of life
Timepoint [7] 0 0
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).
Secondary outcome [8] 0 0
Change in carer depression and anxiety symptoms
Timepoint [8] 0 0
Post assessment - week 8 (primary). Score ranging between 0 to 126 (lower score indicates better outcomes).
Secondary outcome [9] 0 0
For people living with Parkinson's Disease, a change in Parkinsonism symptomology
Timepoint [9] 0 0
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).
Secondary outcome [10] 0 0
For people living with Parkinson's Disease, a change in anxiety
Timepoint [10] 0 0
Post assessment - week 8 (primary). Score ranging between 0 to 40 (lower score indicates better outcomes).
Secondary outcome [11] 0 0
For people living with Parkinson's Disease, a change in anxiety
Timepoint [11] 0 0
Post assessment - week 8 (primary). Score ranging between 0 to 48 (lower score indicates better outcomes).

Eligibility
Key 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).
* 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland University of Technology - Brisbane
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital (RBWH), Metro North Hospital and Health Services - Brisbane
Recruitment hospital [3] 0 0
Surgical, Treatment and Rehabilitation Services (STARS), Metro North Hospital and Health Services - Brisbane
Recruitment hospital [4] 0 0
The University of Queensland - Brisbane
Recruitment hospital [5] 0 0
Princess Alexandra Hospital (PAH), Metro South Hospital and Health Services - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4072 - Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical Research Future Fund
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Metro South Hospital and Health Services
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Metro North Hospital and Health Services
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Queensland University of Technology
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
TalkVia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Lions District 201Q3
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05528302
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nadeeka Dissanayaka, PhD
Address 0 0
Country 0 0
Phone 0 0
+61733466026
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05528302