Feasibility Randomized Control Trial Clinical Trial
Official title:
Mixed-methods, Feasibility Randomized Control Trial of Mindfulness-Based Stress Reduction (MBSR) With Older Adults Living With Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI): a Primary Care Context
| Verified date | March 2019 |
| Source | Women's College Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
People living with subjective cognitive decline (SCD) or mild cognitive impairment (MCI)
experience less efficiency in performing complex everyday tasks, which may result in a
general sense of discontentment and decreased satisfaction with their overall functional
performance. Additionally, SCD and MCI have been associated with concomitant anxiety,
depressive mood, perceived stress, a decrease in emotional well-being and quality-of-life
(QoL) among community-dwelling older adults. These concomitant psychosocial issues may result
in emotional distress which further exacerbates cognitive decline.
At the present time, there is a lack of evidence that supports pharmacologic interventions to
ameliorate concomitant psychosocial issues with this particular population due to medication
side-effects, drug-drug interaction and polypharmacy. Consequently, exploring alternative
non-pharmacological interventions to assist in ameliorating psychosocial issues is an
important consideration. Secondly, evaluating perceived satisfaction on functional
performance with those living with SCD and MCI, and assessing interventions that may support
this is also worthwhile to pursue. Primary care providers are often the first point of
contact when older adults and their families become concerned about memory problems. Health
care professionals, on an interdisciplinary Family Health Team (FHT), such as occupational
therapists, are well-positioned to holistically address both the psychosocial and functional
needs in a client/family centred way with this growing population in primary care. The study
proposes to offer a Mindfulness-Based Stress Reduction (MBSR) program, which is an 8-week
program that has been shown to be beneficial in alleviating emotional distress among adults
living with physical and psychological issues in the general population.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 2020 |
| Est. primary completion date | February 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - age = 60 years - English fluency - living independently in the community - self-reported demographic information that includes either the label of SCD or MCI Exclusion Criteria: - history of prior participation in any MBSR or other mindfulness-based interventions, or participation in regular (weekly) mindfulness or yoga practice - low mood as indicated by a 5 or greater on the Geriatric Depression Scale (GDS) - alcoholism and/or other substance abuse defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) (American Psychiatric Association, 2013 - Montreal Cognitive Assessment (MoCA) of 23 (+/- 4) or under; and - if participating in other concurrent group(s) e.g. cognitive behavioural therapy (CBT) or memory training programs in the community, while in the study. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Women's College Hospital | Toronto | Ontario |
| Canada | Womens College Hospital, Family Health Team | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Women's College Hospital | Queen's University |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Montreal Cognitive Assessment (MoCA) | A brief cognitive screening tool to detect MCI | 10-15 minutes | |
| Other | Geriatric Depression Scale (GDS) | A brief screening instrument for late-life depression | 10 minutes | |
| Primary | Canadian Occupational Performance Measure (COPM) | A client-centred semi-structured interview of client's self-perception of occupational performance issues in the areas of self-care, productivity, and leisure. Five-step process 1. Identification of issues 2. weighting,3. scoring, 4.reassessment and 5. follow-up | 30 mins | |
| Secondary | Geriatric Anxiety Inventory (GAI) | The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms. | 10-15 minutes | |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). | 10-15 minutes | |
| Secondary | Perceived Stress Scale (PSS) | Assessment of global appraisal of stress instead of focusing on a particular event. The focus of the question is reporting on the lives of respondents as i. unpredictable ii. uncontrollable or iii. overloaded. It's a 4-point scale (0-Never and 4-Very Often) with ten questions | 10 minutes | |
| Secondary | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) | A brief measure designed to capture mindfulness in a jargon free and comprehensive way based on Jon Kabat-Zinn's definition of mindfulness. The 10-questionnaire has a 4-point scale (1 - rarely and 10-Almost Always). |
5-10 minutes | |
| Secondary | Quality-of-Life-Alzheimer's Disease (QoL-AD) | The survey has 13-items covering domains (physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole). | 5-10 minutes | |
| Secondary | Acceptance and Action Questionnaire (AAQ) | To measure psychological flexibility and inflexibility. Experiential avoidance is significantly associated with a wide array of behavioral problems as well as psychopathology (Wolgast, 2014) |
5-10 minutes |