NCT05528302

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 Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

July 19, 2022

Last Update Submit

February 1, 2026

Conditions

DementiaCognitive ImpairmentAnxiety

Keywords

DementiaCognitive ImpairmentAnxietyCognitive Behavioural TherapyTechnologyTelehealthRandomized Control Trial

Outcome Measures

Primary Outcomes (1)

  • Change in anxiety

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

    Post-assessment (primary), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 54 (lower score indicates better outcomes).

Secondary Outcomes (11)

  • Change in quality of life

    Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 52 (higher score indicates better outcomes).

  • Change in anxiety

    Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 20 (lower score indicates better outcomes).

  • Change in worry

    Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 8 to 40 (lower score indicates better outcomes).

  • Change in stress

    Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 56 (lower score indicates better outcomes).

  • Change in depressive symptoms

    Post-assessment (~week 8), 3 month follow-up and 6 month follow-up. Score ranging between 0 to 15 (lower score indicates better outcomes).

  • +6 more secondary outcomes

Study Arms (2)

Tech-CBT intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Tech-CBT interventionOTHER

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

Tech-CBT intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Queensland University of Technology

Brisbane, Queensland, 4000, Australia

Location

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

Brisbane, Queensland, 4029, Australia

Location

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

Brisbane, Queensland, 4029, Australia

Location

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

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

Brisbane, Queensland, 4102, Australia

Location

Related Publications (1)

  • Dissanayaka N, Brooks D, Worthy P, Mitchell L, Pachana NA, Byrne G, Keramat SA, Comans T, Bennett S, Liddle J, Chatfield MD, Broome A, Oram J, Appadurai K, Beattie E, Au T, King T, Welsh K, Pietsch A. A single-blind, parallel-group randomised trial of a Technology-assisted and remotely delivered Cognitive Behavioural Therapy intervention (Tech-CBT) versus usual care to reduce anxiety in people with mild cognitive impairment and dementia: study protocol for a randomised trial. Trials. 2023 Jun 20;24(1):420. doi: 10.1186/s13063-023-07381-2.

    PMID: 37340492DERIVED

MeSH Terms

Conditions

DementiaCognitive DysfunctionAnxiety Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2022

First Posted

September 6, 2022

Study Start

February 20, 2023

Primary Completion

October 22, 2025

Study Completion

April 15, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations

AU(5)