Clinical trial NCT04162964: Chair Yoga for Stress in Dementia
Official title: Effectiveness of a Virtual Chair Yoga Intervention for Reducing Stress in Older Adults With Dementia and Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dementia
Stress
Keywords: Dementia
Stress
Caregiving
Mind-body therapy
Anxiety
Depression
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Over 700,000 Canadians are affected by dementia costing the health care system approximately $10 billion/year. Due to COVID-19, the government has urged individuals over the age of 70 to stay home, putting this population at risk of social isolation. Older adults with mild cognitive impairments (MCIs), dementia, and their caregivers are at an even higher risk of becoming stressed, anxious, and agitated while in lockdown. Unsurprisingly, caregiver burden is extremely common, and often precedes institutionalization of the patient, as the demands of the illness begin to exceed that which the caregiver can sustainably provide. Since social distancing measures have shut down activities and support groups for these individuals, there is an urgent need for scalable, cost-effective, non-pharmacological interventions that can be delivered remotely to improve stress and loneliness. Yoga may be a viable therapeutic modality to address the psychological challenges associated with dementia in patients and caregivers, as it has been shown to decrease stress and improve anxiety and depressive symptoms in various populations. For this reason, we are conducting a randomized controlled trial (RCT) to assess the efficacy of an 8-week virtual chair yoga program to improve stress, psychological symptoms, and caregiver burden. This virtual chair yoga study will engage both older adults with dementia/MCI and caregivers (n=40-60 participants) during COVID-19, which is consistent with the need for decreasing costs and increasing accessibility of novel health interventions during and beyond the pandemic. We will evaluate the effect of this program on stress, loneliness, and mental health related outcomes such as fear of COVID-19, depression, anxiety, and caregiver burden compared to a waitlist control group. We will also be conducting a qualitative component in the form of semi-structured interviews. All quantitative outcomes will be assessed before the program starts and post-intervention and qualitative outcomes will be assessed post-intervention. Participants will be randomly assigned to the treatment group (virtual chair yoga 1 hour per week on Zoom) or the waitlist control group. The investigators hypothesize that after the 8-week yoga program, older adults and caregivers will report lower stress, loneliness, depression, anxiety, fear of COVID-19, and caregiver burden. Results will be available late-2021.


Eligibility criteria: Inclusion Criteria for Older Adults:

* Mild cognitive impairment or mild to moderate dementia (MoCA-BLIND score between 8-18 OR a diagnosis from his/her clinician of mild cognitive impairment) or mild to moderate dementia
* Sufficient hearing to follow verbal instructions
* Access to Zoom software and internet connection
* Ability to sit for 60 minutes without discomfort
* At least 60 years old

Exclusion Criteria for Older Adults:

* Severe dementia (MoCA-BLIND score \< 8)
* Acute psychotic symptoms
* Acute suicidal ideation or intent
* Resides outside of Quebec

Inclusion Criteria for Caregivers:

* Providing care for someone with cognitive impairments (mild cognitive impairment or mild, moderate, or severe dementia)
* Sufficient hearing to follow verbal instructions
* Access to Zoom software and internet connection
* Ability to sit for 60 minutes without discomfort
* At least 18 years old

Exclusion Criteria for Caregivers:

* Dementia (MoCA-BLIND score \< 18)
* Acute psychotic symptoms
* Acute suicidal ideation or intent
* Resides outside of Quebec

Primary outcomes:
measure: Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group
timeFrame: Baseline, 8-weeks
Secondary outcomes:
measure: Changes in loneliness scores as measured by the 3-item UCLA Loneliness Scale for treatment group versus control group
timeFrame: Baseline, 8-weeks
Other outcomes:
measure: Changes in caregiver burden as measured by the Zarit Burden Interview (ZBI) for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Changes in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Changes in fear of COVID-19 as measured by the Fear of COVID-19 scale (FC-19S) for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Semi-structured interviews for the Qualitative Component
timeFrame: 8-weeks
Locations:
city: Montreal
country: Canada
facility: Institute of Community and Family Psychiatry
state: Quebec
city: Montreal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
References: