Recruiting

Mindfulness-Based Stress Reduction

Sponsor:

Women's College Hospital

Code:

NCT03867474

Conditions

Feasibility Randomized Control Trial

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Mindfulness-Based Stress Reduction (MBSR)

Study Details

Brief summary:

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.

Conditions

Feasibility Randomized Control Trial

Study ID

NCT03867474

Start date

Oct 3, 2019

Status verified date

Mar, 2019

Completion date

Aug, 2020

Anticipated

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention (MBSR)

Mindfulness-Based Stress Reduction (MBSR) - Intervention Arm

no intervention: Control - Usual Care

Control

Interventions

Mindfulness-Based Stress Reduction (MBSR)

The intervention group will be delivered in a group-based format, for one three-hour session per week for an 8-week period. Each session will consist of mindfulness practice (e.g. lying down body scan, sitting meditation, mindful eating, mindful movements such as walking and light hatha yoga movements) along with an inquiry about the practice. Strategies on stress reactivity, responding to stress, and some basic content on cognitive behaviour therapy principles will also be taught. Participants will be placed in dyads during the group. Homework practice will be given to complete on a daily basis for approximately 30-45 minutes. During week six participants will attend an all-day silent meditation retreat on a Saturday (Total of 10 sessions = 8 sessions, 1 orientation, and 1 all-day retreat).

Primary outcome measure

  • Canadian Occupational Performance Measure (COPM) [ Time Frame: 30 mins ]

Central Contacts and Locations

Locations

Womens College Hospital, Family Health Team

Recruiting

Toronto, Ontario, Canada, M4Y 2V6

Contacts

More Information

Sponsor

Women's College Hospital

Last update posted

Feb 5, 2020

Last verified

Mar, 2019

Keywords

  • Mindfulness, Primary Care, MBSR, Cognitive Impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women's College Hospital on 2020-02-05.