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

January 31, 2020 updated by: Todd Tran, Women's College Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Purpose: The overarching purpose of this study is to determine whether MBSR is appropriate for a larger clinical trial. AIM 1: To explore the feasibility of conducting a randomized control trial (RCT) of an occupational therapist-led, 8-week MBSR program in an interprofessional primary care setting, with the following objectives: 1a. To assess participant recruitment, intervention adherence, and study retention, 1b. To explore the acceptability of delivering technology-based tablets (iPads) for intervention, and data collection in the MBSR program and 1c. To explore the perspectives of participants and healthcare providers with respect to satisfaction (e.g. the intervention and its delivery), perceived value, barriers to and facilitators of acceptability of this 8-week MBSR program in primary care.

AIM 2: To evaluate the impact of MBSR on satisfaction with functional performance and psychosocial outcomes in individuals with SCD or MCI with the following objectives: 2a. To determine the effect sizes of satisfaction with functional performance and psychosocial outcomes Methods: A convergent mixed-methods, feasibility randomized control trial will be used. Participants will be randomized into an 8-week intervention or control group (usual care) and these groups will be compared at three different time points. Initially, data analysis will involve collecting and analyzing the quantitative and qualitative strands separately. Both qualitative and quantitative data will then be merged for comparative analysis to best understand both the feasibility of a larger clinical trial and to explore preliminary clinical outcomes from the study.

Significance: The results gained from this study will help to determine the feasibility of pursuing a future fully powered trial. Ultimately, this line of research will determine if there are potential benefits of MBSR in improving perceived satisfaction of functional performance and alleviating concomitant psychosocial issues that is associated with those living with SCD and MCI.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Not yet recruiting
        • Women's College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Todd D Tran, PhD(cand)
        • Sub-Investigator:
          • Emily Nalder, PhD
        • Sub-Investigator:
          • Tracy Trothen, PhD
        • Sub-Investigator:
          • Marcia Finlayson, PhD
      • Toronto, Ontario, Canada, M4Y 2V6
        • Recruiting
        • Womens College Hospital, Family Health Team
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention (MBSR)
Mindfulness-Based Stress Reduction (MBSR) - Intervention Arm
Behavioral: 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).
NO_INTERVENTION: Control - Usual Care
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure (COPM)
Time Frame: 30 mins
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geriatric Anxiety Inventory (GAI)
Time Frame: 10-15 minutes
The Geriatric Anxiety Inventory (GAI) consists of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms.
10-15 minutes
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 10-15 minutes
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
Perceived Stress Scale (PSS)
Time Frame: 10 minutes
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
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time Frame: 5-10 minutes

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
Quality-of-Life-Alzheimer's Disease (QoL-AD)
Time Frame: 5-10 minutes
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
Acceptance and Action Questionnaire (AAQ)
Time Frame: 5-10 minutes

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: 10-15 minutes
A brief cognitive screening tool to detect MCI
10-15 minutes
Geriatric Depression Scale (GDS)
Time Frame: 10 minutes
A brief screening instrument for late-life depression
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 3, 2019

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (ACTUAL)

March 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0056-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Unsure at the present moment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Feasibility Randomized Control Trial

Clinical Trials on Mindfulness-Based Stress Reduction (MBSR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe