Chair Yoga for Stress in Dementia
Primary Purpose
Dementia, Stress
Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Chair Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Dementia, Stress, Caregiving, Mind-body therapy, Anxiety, Depression
Eligibility Criteria
Inclusion Criteria:
- Patients will have mild cognitive impairment or mild to moderate dementia (MMSE score between 10-26 inclusive) OR a diagnosis from his/her clinician of mild cognitive impairment or mild to moderate dementia
- Patient and caregiver have contact at least 3 times per week
- Either patient and/or caregiver will have a score of at least 10 on the PSS
- Sufficient hearing to follow verbal instructions
- Able to sit for 45 minutes without discomfort
Exclusion Criteria:
- Patients will not have severe dementia (MMSE score < 10 OR diagnosis from his/her clinician)
- Caregivers will not have dementia (MMSE score < 24)
- Acute psychotic symptoms
- Acute suicidal ideation or intent
Sites / Locations
- Institute of Community and Family Psychiatry
- Douglas Mental Health University Institute
Outcomes
Primary Outcome Measures
Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS)
Using an 8-week single arm pilot trial, assess the effects of chair yoga on perceived stress in patients and caregivers, using the PSS.
Scores on the PSS can range from 0-40, with higher scores indicating higher perceived stress
Hypothesis: Following participation in an 8-week gentle chair yoga program, patients with dementia and their caregivers will report lower perceived stress, as measured by the Perceived Stress Scale (PSS)
Secondary Outcome Measures
Changes in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Using an 8-week single arm pilot trial, assess the effects of chair yoga on patient and caregiver depressive symptoms using the PHQ-9.
Scores on the PHQ-9 can range from 0-27, with higher scores indicating more severe depression.
Hypothesis: Patients with dementia and their caregivers will report less severe symptoms of depression, as measured by the full version of the Patient Health Questionnaire (PHQ-9), following participation in an 8-week gentle chair yoga program.
Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7)
Using an 8-week single arm pilot trial, assess the effects of chair yoga on symptoms of anxiety in patients and caregivers using the GAD-7.
Scores on the GAD-7 range from 0-21, with higher scores indicating more severe anxiety.
Hypothesis: Patients with dementia and/or their caregivers will report fewer symptoms of anxiety, as measured by the Generalized Anxiety Disorder 7-Item Scale (GAD-7), following participation in an 8-week gentle chair yoga program.
Full Information
NCT ID
NCT04162964
First Posted
October 29, 2019
Last Updated
September 8, 2020
Sponsor
Lady Davis Institute
1. Study Identification
Unique Protocol Identification Number
NCT04162964
Brief Title
Chair Yoga for Stress in Dementia
Official Title
Effectiveness of a Dyadic Chair Yoga Intervention for Reducing Stress in Patients With Dementia and Their Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Suspended
Why Stopped
COVID-19
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute
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
Dementia is widely prevalent and results in high direct and indirect health costs. Dementia is associated with stress, anxiety, and depression in both patients and caregivers, and caregiver burden is extremely common. Treatment protocols for patients and caregivers are unclear and insufficient; drug treatments to manage behavioural and psychological symptoms of dementia can yield serious negative side effects, and caregivers may not have access to one-on-one psychotherapy due to high costs and long wait times. Yoga is an ancient Indian mind-body practice that uses physical postures, breathing exercises, and meditation. 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. Recent research has suggested that patients with dementia and their caregivers may also experience positive effects on their mental health from practicing yoga. Furthermore, when yoga is taught in a gentle and mindful manner, it is generally not associated with any negative side effects. While there is preliminary data on dyadic exercise interventions for dementia patients and their caregivers, to date no research has examined the effectiveness of a dyadic yoga intervention on stress, anxiety, and depression.
The investigators propose an 8-week study of a dyadic chair yoga program for patients with mild to moderate dementia and their caregivers (n = 30-40 participants). Our primary outcome of interest is changes in perceived stress, while secondary outcomes include changes in symptoms of depression and anxiety. The investigators will also look at the effects of the chair yoga program on caregiver burden, quality of interactions, well-being, mindfulness, and self-compassion. All outcomes will be assessed before the program starts and upon its termination. Participants will attend a 1-hour weekly group yoga class (4-10 participants per group) with their dyad for 8-weeks, and will also be given a video recording of a yoga class to practice together at home as often as possible. The investigators hypothesize that after the 8 week yoga program, patients and caregivers will report lower stress, as well as reduced symptoms of anxiety and depression. Results will be available mid-2020.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Stress
Keywords
Dementia, Stress, Caregiving, Mind-body therapy, Anxiety, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Chair Yoga
Intervention Description
8-week dyadic chair yoga program for one hour per week. Chair yoga is an effective way to offer modified yoga postures and relaxation techniques to individuals with limited mobility and/or advanced age for whom mat-based classes may not be accessible. The weekly yoga classes will be lead by a certified instructor and will include 4-10 participants (or 2-5 patient-caregiver dyads).
Primary Outcome Measure Information:
Title
Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS)
Description
Using an 8-week single arm pilot trial, assess the effects of chair yoga on perceived stress in patients and caregivers, using the PSS.
Scores on the PSS can range from 0-40, with higher scores indicating higher perceived stress
Hypothesis: Following participation in an 8-week gentle chair yoga program, patients with dementia and their caregivers will report lower perceived stress, as measured by the Perceived Stress Scale (PSS)
Time Frame
Baseline, 8-weeks
Secondary Outcome Measure Information:
Title
Changes in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Description
Using an 8-week single arm pilot trial, assess the effects of chair yoga on patient and caregiver depressive symptoms using the PHQ-9.
Scores on the PHQ-9 can range from 0-27, with higher scores indicating more severe depression.
Hypothesis: Patients with dementia and their caregivers will report less severe symptoms of depression, as measured by the full version of the Patient Health Questionnaire (PHQ-9), following participation in an 8-week gentle chair yoga program.
Time Frame
Baseline, 8-weeks
Title
Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
Using an 8-week single arm pilot trial, assess the effects of chair yoga on symptoms of anxiety in patients and caregivers using the GAD-7.
Scores on the GAD-7 range from 0-21, with higher scores indicating more severe anxiety.
Hypothesis: Patients with dementia and/or their caregivers will report fewer symptoms of anxiety, as measured by the Generalized Anxiety Disorder 7-Item Scale (GAD-7), following participation in an 8-week gentle chair yoga program.
Time Frame
Baseline, 8-weeks
Other Pre-specified Outcome Measures:
Title
Changes in caregiver burden as measured by the Zarit Burden Inventory (ZBI)
Description
Assess the effects of chair yoga on caregiver burden using the ZBI following 8 weeks of chair yoga.
Scores on the ZBI can range from 0-88, with higher scores corresponding to higher levels of burden.
Hypothesis 1: Caregivers of patients with dementia will report lower caregiver burden, as measured by the Zarit Burden Scale (ZBI), following participation in an 8-week gentle chair yoga program.
Hypothesis 2: Lower patient scores on the PHQ-9 and GAD-7 (week 8) will be associated with decreased caregiver burden following participation in an 8-week gentle chair yoga program.
Time Frame
Baseline, 8-weeks
Title
Changes in relationship closeness as measured by the Whitlatch Relationship Closeness Scale
Description
Assess the effects of chair yoga on levels of caregiver-rated relationship closeness using the Whitlatch Relationship Closeness Scale.
Scores on the Whitlatch Relationship Closeness Scale range from 0-24, with higher scores indicating closer relationships.
Time Frame
Baseline, 8-weeks
Title
Changes in well-being as measured by the 12-Item Well-Being Questionnaire (W-BQ12)
Description
Assess the effects of 8-weeks of chair yoga on patient and caregiver well-being using the W-BQ12.
Scores on the W-BQ12 range from 0-72, with higher scores indicating a greater sense of well-being.
Time Frame
Baseline, 8-weeks
Title
Changes in levels of mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ-short form)
Description
Assess the effects of 8 weeks of chair yoga on patient and caregiver levels of mindfulness using the short form of the FFMQ.
Scores on the short-form of the Five Facet Mindfulness Scale range from 0-120, with higher scores indicating higher levels of mindfulness.
Time Frame
Baseline, 8-weeks
Title
Changes in levels of self-compassion as measured by the Self-Compassion Scale (SCS-short form)
Description
Assess the effects of 8 weeks of chair yoga on patient and caregiver levels of self-compassion using the short form of the SCS.
Scores on the short for of the SCS range from 0-60, with higher scores indicating higher levels of self-compassion.
Time Frame
Baseline, 8-weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will have mild cognitive impairment or mild to moderate dementia (MMSE score between 10-26 inclusive) OR a diagnosis from his/her clinician of mild cognitive impairment or mild to moderate dementia
Patient and caregiver have contact at least 3 times per week
Either patient and/or caregiver will have a score of at least 10 on the PSS
Sufficient hearing to follow verbal instructions
Able to sit for 45 minutes without discomfort
Exclusion Criteria:
Patients will not have severe dementia (MMSE score < 10 OR diagnosis from his/her clinician)
Caregivers will not have dementia (MMSE score < 24)
Acute psychotic symptoms
Acute suicidal ideation or intent
Facility Information:
Facility Name
Institute of Community and Family Psychiatry
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E4
Country
Canada
Facility Name
Douglas Mental Health University Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Chair Yoga for Stress in Dementia
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