Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment

NCT05030285 | Completed

• 1 other identifier: HREC/17/QRBW/676
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotherapy; Cognitive Impairment; Anxiety

Keywords

Psychotherapy; Cognitive Impairments; Anxiety

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 (week 8). Scores ranging between 0 to 54 (lower score indicates better outcomes)

Secondary Outcomes (3)

• Change in depression

  Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes)

• Change in quality of life

  Post assessment (week 8). Scores ranging between 0 to 52 (higher score indicates better outcomes)

• Change in carer burden

  Post assessment (week 8). Scores ranging between 0-88 (lower score indicates better outcomes)

Study Arms (2)

Intervention

EXPERIMENTAL

People who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions

Behavioral: Cognitive Behavioral Therapy (CBT)

Control

NO INTERVENTION

People who are randomised into the control arm will undergo usual care

Interventions

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

Related Publications (6)

• 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.

  PMID: 30536144 BACKGROUND

• 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.

  PMID: 25685141 BACKGROUND

• 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.

  PMID: 11281317 BACKGROUND

• 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.

  PMID: 22055973 BACKGROUND

• 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.

  PMID: 31752633 BACKGROUND

• 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.

  PMID: 31646432 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nadeeka Dissanayaka, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to what arm the participant is allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised (1:1 ratio) to either the Tele-CBT intervention or usual care (Control) arm.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: September 21, 2021
• Primary Completion: July 16, 2022
• Study Completion: July 16, 2022
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

AU (1)