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

The University of Queensland

Status: Active, not recruiting

Conditions: Cognitive Impairment; Anxiety; Dementia

Treatments: Other: Tech-CBT intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05528302

HREC/2022/QRBW/83925

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Tech-CBT intervention

Experimental group

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.

Treatment:

Other: Tech-CBT intervention

Control

No Intervention group

Description:

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.