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Completed

NCT Number: NCT04044183

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

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.

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Key information

Conditions

Chronic Pain Behavior Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Motor Activity Neurocognitive Disorders Neurologic Manifestations Older Adults Pain Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active Brains 1

Behavioral

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.

Active Brains 2

Behavioral

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.

Primary outcomes

  1. Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint

    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 outcomes

  1. Proportion of Participants With Valid Digital Monitoring Device Wear

    Time frame: 0 Weeks, 8 Weeks

    The proportion of patients with valid ActiGraph (digital monitoring device) wear for greater than or equal to 6 days (7+ hr/day) at baseline and 5 days at post test

  2. Proportion of Participants With Valid Adherence to Homework

    Time frame: 0 Weeks, 8 Weeks

    Proportion of participants completing at least 5 out of 7 days of homework assigned throughout the study

  3. Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills

    Time frame: 0 Weeks, 8 Weeks

    Percentage of audio recordings, progress notes, and checklists that were completed with 100% of content delivered for each session

  4. Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)

    Time frame: 0 Weeks, 8 Weeks

    Percentage of questionnaires that were entirely missing in >25% of participants and/or had an internal reliability below .70

  5. Proportion of Participants Using Rescue (Non-Narcotic) Analgesics

    Time frame: 0 Weeks

    Single-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline

  6. Proportion of Participants Using Narcotic Analgesics

    Time frame: 0 Weeks

    Single-item question on demographics form indicating whether participant used narcotic analgesics at baseline

  7. Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint

    Time frame: 0 Weeks

    Number of participants rating expectations and believed credibility for the program above and below the scale midpoint, 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. Scores range from 0-119, with higher scores indicating greater levels of activity.

  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. Total scores are an average of the items (range = 1-5), 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, total scores ranging from 0-100, 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. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher perceived social support.

  18. T-Score for PROMIS Depression

    Time frame: 0 Weeks, 8 Weeks

    Rate of a participant's depressive symptoms, with items ranging from 1-5. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher depression.

  19. T-Score for PROMIS Anxiety

    Time frame: 0 Weeks, 8 Weeks

    Rate of a participant's fear, anxious, hyper arousal, and somatic symptoms pertaining to arousal. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher 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. 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

  24. 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

  25. 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

  26. ActiGraph Average Steps

    Time frame: 0 weeks, 8 weeks

    Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.

  27. Six-Minute Walk Test (6MWT)

    Time frame: 0 weeks, 8 weeks

    The Six-Minute Walk Test (6MWT) measures the distances participants can walk at an accelerated pace in meters over a 6-minute span.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Active Brains: Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment (MCI) or Memory Related Problems (MRP) and Chronic Pain

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 5, 2019
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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