Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment (Tele-CBT)
Primary Purpose
Psychotherapy, Cognitive Impairment, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Psychotherapy focused on measuring Psychotherapy, Cognitive Impairments, Anxiety
Eligibility Criteria
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
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.
Sites / Locations
- The University of QueenslandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
People who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions
People who are randomised into the control arm will undergo usual care
Outcomes
Primary Outcome Measures
Change in anxiety
Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID).
Secondary Outcome Measures
Change in depression
Change from baseline in depression as measured by the Geriatric Depression Scale (GDS)
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)
Change in carer burden
Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI)
Full Information
NCT ID
NCT05030285
First Posted
August 26, 2021
Last Updated
May 30, 2022
Sponsor
The University of Queensland
1. Study Identification
Unique Protocol Identification Number
NCT05030285
Brief Title
Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
Acronym
Tele-CBT
Official Title
Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Anxiety is a pre-existing mental health issue in older persons with cognitive impairment (includes people with mild cognitive impairment (MCI) and dementia), with considerably high prevalence (14%) as compared to older persons in the general population (3%). Anxiety results in accelerated cognitive decline, increased aggressive behaviours, and even an increased risk of suicide. Anxiety also negatively influences quality of life (QoL) of the individual with cognitive impairment and their care partner, increases early institutionalisation, and amplifies economic burden.
The Tele-CBT package used in this study is a modification of existing manualised psychotherapeutic interventions for treatment of anxiety in people with Parkinson's disease and older adults with cognitive impairment. This new package incorporates techniques tailored to reduce anxiety in people with cognitive impairment, including symptom monitoring. The interventions will include various psychological techniques aimed at reducing anxiety and stress. The intervention consists of 6 weekly psychotherapy sessions. Each therapy session lasts between 30-60 minutes, depending on the participants' capacity to actively participate in session and on their cognitive functioning (e.g. complex attention, executive function). Support persons will be invited and instructed to actively engage in the therapy sessions as well as in between-session home tasks to support the person with cognitive impairment. These techniques will be facilitated via the use of non-immersive videos in telehealth videoconferencing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotherapy, Cognitive Impairment, Anxiety
Keywords
Psychotherapy, Cognitive Impairments, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised (1:1 ratio) to either the Tele-CBT intervention or usual care (Control) arm.
Masking
Outcomes Assessor
Masking Description
Assessors will be blinded to what arm the participant is allocated to.
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
People who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions
Arm Title
Control
Arm Type
No Intervention
Arm Description
People who are randomised into the control arm will undergo usual care
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety
Description
Change from baseline in anxiety as measured by the Rating Anxiety in Dementia Scale (RAID).
Time Frame
Post assessment (week 8). Scores ranging between 0 to 54 (lower score indicates better outcomes)
Secondary Outcome Measure Information:
Title
Change in depression
Description
Change from baseline in depression as measured by the Geriatric Depression Scale (GDS)
Time Frame
Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes)
Title
Change in quality of life
Description
Change from baseline in quality of life as measured by the Quality of Life in Alzheimer's Disease (QoL-AD)
Time Frame
Post assessment (week 8). Scores ranging between 0 to 52 (higher score indicates better outcomes)
Title
Change in carer burden
Description
Change from baseline in carer burden as measured by the Zarit Burden Inventory (ZBI)
Time Frame
Post assessment (week 8). Scores ranging between 0-88 (lower score indicates better outcomes)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadeeka Dissanayaka, PhD
Phone
617 3346 6026
Email
n.dissanayaka@uq.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Au, BBiomedSc
Phone
617 3346 5577
Email
t.au@uq.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeeka Dissanayaka, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadeeka Dissanayaka
Phone
+61733466026
Email
t.au@uq.edu.au
First Name & Middle Initial & Last Name & Degree
Tiffany Au
Phone
+61733465577
Email
t.au@uq.edu.au
12. IPD Sharing Statement
Citations:
PubMed Identifier
30536144
Citation
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.
Results Reference
background
PubMed Identifier
25685141
Citation
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.
Results Reference
background
PubMed Identifier
11281317
Citation
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.
Results Reference
background
PubMed Identifier
22055973
Citation
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.
Results Reference
background
PubMed Identifier
31752633
Citation
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.
Results Reference
background
PubMed Identifier
31646432
Citation
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.
Results Reference
background
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Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment
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