Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

NACOMPLETED

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 details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

Study ID

NCT05528302

Intervention or treatment

OTHER: Tech-CBT intervention

Conditions

Dementia
Cognitive Impairment
Anxiety

Condition: Dementia, Cognitive Impairment and more
OTHER: Tech-CBT intervention
Brisbane, Queensland, Australia and more
Sponsor: The University of Queensland

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Queensland University of Technology

Select from list below to view details:

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

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Who is running the clinical trial?

TUoQ

The University of Queensland

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?

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
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.

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

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

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

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).

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References

Clinical Trials Gov: Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment

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