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Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain

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ClinicalTrials.gov Identifier: NCT04044183
Recruitment Status : Unknown
Verified September 2020 by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : August 5, 2019
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Study Description
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Brief Summary:
We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain, Active Brains 1 and Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning.

Condition or disease Intervention/treatment Phase
Chronic Pain Mild Cognitive Impairment Older Adults Physical Activity Behavioral: Active Brains 1 Behavioral: Active Brains 2 Not Applicable

Detailed Description:

We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain: Active Brains 1 Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning.

Each group meets for 8 90 minute sessions over a secure video platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 2 assessment points: baseline, and post program. Assessments involve questionnaires, a walk test, and objective step count with ActiGraphs for 1 week.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Active Brains: Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment (MCI) or Memory Related Problems (MRP) and Chronic Pain
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Memory

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Brains
Active Brains uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The Active Brains sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is an 8-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. Active Brains 1 uses a digital monitoring device (i.e., Fitbit) for recording of physical activity.
 Behavioral: Active Brains 1
Active Brains uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The Active Brains sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is an 8-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. Active Brains 1 uses a digital monitoring device (i.e., Fitbit) for recording of physical activity.

Behavioral: Active Brains 2
This active comparison condition controls for the effect of time spent, group member support/feedback, and interventionist support/feedback. The original HEP was adapted to provide population-specific information on chronic pain and MCI/MRP symptoms. Participants also receive lifestyle education consistent from public health recommendations and standards for health promotion (e.g., "Sleep", "Nutrition", "Healthy Weight", and "Medical appointments"). The HEP program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The HEP is conducted in the same format as Active Brains-Fitbit but are not taught the mind-body, walking, or cognitive-behavioral skills. HEP participants are encouraged to set lifestyle goals instead of quota-based walking goals aided by the Fitbit as in the Active Brains-Fitbit condition.
Placebo Comparator: Active Brains 2
This active comparison condition controls for the effect of time spent, group member support/feedback, and interventionist support/feedback. The original HEP was adapted to provide population-specific information on chronic pain and MCI/MRP symptoms. Participants also receive lifestyle education consistent from public health recommendations and standards for health promotion (e.g., "Sleep", "Nutrition", "Healthy Weight", and "Medical appointments"). The HEP program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The HEP is conducted in the same format as Active Brains-Fitbit but are not taught the mind-body, walking, or cognitive-behavioral skills. HEP participants are encouraged to set lifestyle goals instead of quota-based walking goals aided by the Fitbit as in the Active Brains-Fitbit condition.
 Behavioral: Active Brains 1
Active Brains uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The Active Brains sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is an 8-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. Active Brains 1 uses a digital monitoring device (i.e., Fitbit) for recording of physical activity.

Behavioral: Active Brains 2
This active comparison condition controls for the effect of time spent, group member support/feedback, and interventionist support/feedback. The original HEP was adapted to provide population-specific information on chronic pain and MCI/MRP symptoms. Participants also receive lifestyle education consistent from public health recommendations and standards for health promotion (e.g., "Sleep", "Nutrition", "Healthy Weight", and "Medical appointments"). The HEP program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The HEP is conducted in the same format as Active Brains-Fitbit but are not taught the mind-body, walking, or cognitive-behavioral skills. HEP participants are encouraged to set lifestyle goals instead of quota-based walking goals aided by the Fitbit as in the Active Brains-Fitbit condition.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Client Satisfaction Questionnaire 3-Item (CSQ-3) [ Time Frame: 8 Weeks ]
    Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction


Secondary Outcome Measures :
  1. Adherence to DMD (digital monitoring device) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of participant's use of DMD throughout the study

  2. Adherence to Homework [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of participant's completion of homework assigned throughout the study

  3. Therapist Adherence to Session [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of interventionist's delivering the programs by following the established session topics and skills

  4. Feasibility of Quantitative Measures [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of participant's completion of self-report measures

  5. Rescue (Non-Narcotic) Analgesic Use [ Time Frame: 0 Weeks ]
    Single-item question on demographics form

  6. Narcotic Analgesic Use [ Time Frame: 0 Weeks ]
    Single-item question on demographics form

  7. Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: 0 Weeks ]
    Rate of participant's expectations and believed credibility for program, with higher ratings indicating more belief that the program is logical and will help with the intended outcome

  8. Montreal Cognitive Assessment (MoCA) [ Time Frame: 0 Weeks, 8 Weeks ]
    Assesses several cognitive domains and detection of mild cognitive impairment (MCI), with scores ranging from 0-30 and lower scores indicating greater cognitive decline

  9. Godin Leisure-Time Exercise Questionnaire [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of participant's leisure time and physical activity levels by indicating how many days per week are spent doing the activity for more than 15 minutes

  10. Measure of Current Status (MOCS-A) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's self-reported perceived stress self-management skills, with items ranging from 0-4 and a total score ranging from 0-52, and higher scores reflecting more usage of stress self-management skills

  11. The Measurement of Everyday Cognition (eCog) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of participant's cognitively mediated functional abilities, with items ranging from 1-5, with a total score ranging from 12-60, with higher scores indicating greater cognitive decline

  12. Numerical Rating Scale [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being the worst possible pain

  13. The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness

  14. WHO Disability Assessment Schedule 2.0 [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's health and disability, with items ranging from 0-4, and higher scores reflecting greater disability

  15. The Gratitude Questionnaire (GQ-6) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's proneness to experience gratitude in daily life, with items ranging from 1-7, total scores ranging from 6-24, and a higher score indicating greater amount of gratitude

  16. PROMIS Physical Function [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4, and total scores ranging from 8-40, with a higher score reflecting greater physical function

  17. PROMIS Emotional Support [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's perceived feelings of being cared and values for as an individual, with items ranging from 1-5, total scores ranging from 4-20, and a higher score indicating higher perceived social support

  18. PROMIS Depression [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's negative mood, social cognition, and views of self, with items ranging from 1-5, total scores ranging from 8-40, and a higher score reflecting higher levels of depression

  19. PROMIS Anxiety [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's fear, anxious, hyper arousal, and somatic symptoms pertaining to arousal, with items ranging from 1-5, total scores ranging from 8-40, and a high score reflecting higher levels of anxiety

  20. Pain Catastrophizing Scale (PCS) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's pain experience, with items ranging from 0-4, and total scores ranging from 0-52, with higher scores indicating higher levels of pain catastrophizing

  21. UCLA Loneliness Scale [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's feelings of loneliness and social isolation and items range from 0-3, with a higher score reflecting greater feelings of loneliness, with total scores ranging from 0-24

  22. Pain Self Efficacy Questionnaire (PSEQ) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's confidence to do various activities despite their pain, with items ranging from 0-6, and a higher score showing greater levels of confidence with pain self-efficacy, with total scores ranging from 0-60

  23. The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's sleep quality and patterns of sleep with total scores ranging from 0 to 21, with higher scores indicating greater sleep disturbance

  24. Tampa Kinesiophobia Scale [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's fear of movement, with items ranging from 1-4, and a total scores ranging from 17-68, and higher scores indicating higher levels of fear of movement

  25. Chronic Pain Acceptance Questionnaire [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's acceptance of chronic pain, with scores ranging from 0-6, with the total score ranging from 0-48, and higher scores indicating higher levels of acceptance of chronic pain

  26. Self-Compassion Scale (SCS) [ Time Frame: 0 Weeks, 8 Weeks ]
    Rate of a participant's amount of self-compassion, with items ranging from 1-5, and total scores ranging from 12-60 and higher scores indicating higher levels of self-compassion

  27. Demographics [ Time Frame: 0 Weeks ]
    Questionnaire that asks individuals to report on: date of birth, gender, weight, height, handedness, ethnicity, race, martial status, education level, employment status, type of job, income, pain diagnoses, length of chronic pain, other medical conditions, mental health conditions, pain medications, cognitive preservations

  28. Additional Exit Interview Questions [ Time Frame: 8 Weeks ]
    Asks about specific components related to the program and the helpfulness of the program for chronic pain and cognition


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, age 60 years or older
  • Have nonmalignant chronic pain for more than 3 months
  • Has MCI or subjective memory related problems
  • Able to perform a 6-minute walk test at an accelerated pace
  • Owns a smartphone with Bluetooth 4.0
  • Willingness and ability to participate in the Active Brains intervention and to comply with the requirements of the study protocol (including weekly sessions and Fitbit use)
  • Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
  • Cleared by a medical doctor for study participation
  • Leads a sedentary lifestyle

Exclusion Criteria:

  • Diagnosed with medical illness expected to worsen in the next 6 months
  • Serious mental illness or instability for which hospitalization may be likely in the next 6 months
  • Current suicidal ideation reported on self-report
  • Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
  • Current substance use disorder, within the past 6 months
  • Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
  • Regular use of Fitbit in the last 3 months
  • Engagement in regular intensive physical exercise for >30 minute daily
  • Unable to walk without use of assistance (e.g., wheelchair, walker)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044183


Contacts
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Contact: Ana-Maria Vranceanu, PhD 6176437996 avranceanu@mgh.harvard.edu
Contact: Paula Popok, BA 6177240051 ppopok@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ana-Maria Vranceanu, PhD    617-643-7996    avranceanu@mgh.harvard.edu   
Contact: Paula Popok, BA    6177240051    ppopok@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ana-Maria Vranceanu, PhD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ana-Maria Vranceanu, PhD, Associate Professor/Director, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04044183    
Other Study ID Numbers: 2018P002152
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:
Chronic Pain
Mild Cognitive Impairment
Older Adults
Physical Activity
Memory Related Problems
Additional relevant MeSH terms:
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Chronic Pain
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
 Mental Disorders
Pain
Neurologic Manifestations