Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment

Conditions
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Psychotherapy, Cognitive Impairment, Anxiety

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomised (1:1 ratio) to either the Tele-CBT intervention or usual care (Control) arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>People who are randomised into the intervention arm will undergo 6 weekly psychotherapy sessions | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* 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.<br>|
| No Intervention: Control<br>People who are randomised into the control arm will undergo usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). Scores ranging between 0 to 54 (lower score indicates better outcomes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression | Change from baseline in depression as measured by the Geriatric Depression Scale (GDS) | Post assessment (week 8). Scores ranging between 0 to 15 (lower score indicates better outcomes) | 
| 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). Scores ranging between 0 to 52 (higher 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). Scores ranging between 0-88 (lower score indicates better outcomes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, Cognitive Impairments, Anxiety