Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05030285




Registration number
NCT05030285
Ethics application status
Date submitted
26/08/2021
Date registered
1/09/2021
Date last updated
2/06/2022

Titles & IDs
Public title
Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
Scientific title
Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
Secondary ID [1] 0 0
HREC/17/QRBW/676
Universal Trial Number (UTN)
Trial acronym
Tele-CBT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotherapy 0 0
Cognitive Impairment 0 0
Anxiety 0 0
Condition category
Condition code
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
Behaviour - Cognitive Behavioral Therapy (CBT)

Experimental: Intervention - People who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions

No Intervention: Control - People who are randomised into the control arm will undergo usual care


Behaviour: 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.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in anxiety
Timepoint [1] 0 0
Post assessment (week 8). Scores ranging between 0 to 54 (lower score indicates better outcomes)
Secondary outcome [1] 0 0
Change in depression
Timepoint [1] 0 0
Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes)
Secondary outcome [2] 0 0
Change in quality of life
Timepoint [2] 0 0
Post assessment (week 8). Scores ranging between 0 to 52 (higher score indicates better outcomes)
Secondary outcome [3] 0 0
Change in carer burden
Timepoint [3] 0 0
Post assessment (week 8). Scores ranging between 0-88 (lower score indicates better outcomes)

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05030285
Trial related presentations / 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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Nadeeka Dissanayaka, PhD
Address 0 0
The University of Queensland
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
617 3346 6026
Fax 0 0
Email 0 0
n.dissanayaka@uq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05030285