Mindfulness-Based Stress Reduction With Older Adults Living With Cognitive Impairment in Primary Care.

NCT03867474 | Unknown

• 1 other identifier: 2017-0056-E
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

Mindfulness, Primary Care, MBSR, Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Geriatric Anxiety Inventory (GAI)

  10-15 minutes

• Patient Health Questionnaire-9 (PHQ-9)

  10-15 minutes

• Perceived Stress Scale (PSS)

  10 minutes

• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

  5-10 minutes

• Quality-of-Life-Alzheimer's Disease (QoL-AD)

  5-10 minutes

Other Outcomes (2)

• Montreal Cognitive Assessment (MoCA)

  10-15 minutes

• Geriatric Depression Scale (GDS)

  10 minutes

Study Arms (2)

Intervention (MBSR)

EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR) - Intervention Arm

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Control - Usual Care

NO INTERVENTION

Control

Interventions

Mindfulness-Based Stress Reduction (MBSR) BEHAVIORAL

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).

Intervention (MBSR)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 60 years
• English fluency
• living independently in the community
• self-reported demographic information that includes either the label of SCD or MCI

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• Queen's University: collaborator

Study Sites (2)

Womens College Hospital, Family Health Team

Toronto, Ontario, M4Y 2V6, Canada

RECRUITING

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

NOT YET RECRUITING

Related Publications (2)

• Tran T, Donnelly C, Nalder E, Trothen T, Finlayson M. Mindfulness-based stress reduction for community-dwelling older adults with subjective cognitive decline (SCD) and mild cognitive impairment (MCI) in primary care: a mixed-methods feasibility randomized control trial. BMC Prim Care. 2023 Feb 9;24(1):44. doi: 10.1186/s12875-023-02002-y.

  PMID: 36759766 DERIVED

• Tran T, Donnelly C, Nalder EJ, Trothen T, Finlayson M. Occupational therapist-led mindfulness-based stress reduction for older adults living with subjective cognitive decline or mild cognitive impairment in primary care: a feasibility randomised control trial protocol. BMJ Open. 2020 Jun 23;10(6):e035299. doi: 10.1136/bmjopen-2019-035299.

  PMID: 32580984 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Enrollment, Randomization and Blinding
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: October 3, 2019
• Primary Completion: February 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)