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Completed

NCT Number: NCT05373745

Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain

The investigators aim to conduct a fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors. Both programs will be delivered virtually (Zoom).

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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

The investigators aim to conduct a fully powered randomized controlled trial to establish efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how the two programs may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors, and type of early cognitive decline. Both programs will be delivered virtually (Zoom).

Each group meets for eight, 90 minutes sessions over the secure Zoom platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 3 assessment points: baseline, post program and 6-month follow-up. Assessments involve self-report questionnaires, a walk test and a neuropsychological evaluation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female outpatients, age 60 years or older
  • Have nonmalignant chronic pain for more than 3 months
  • Reports early cognitive decline (subjective or objective)
  • Telephone Interview for Cognitive Status-30 score greater than or equal to 17
  • Functional Activities Questionnaire score less than 9
  • Able to perform a 6-minute walk test at an accelerated pace
  • English fluency/literacy
  • Willingness and ability to participate and use an ActiGraph watch and smartphone app to view and sync the step count and sleep data
  • 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 and no self-reported concerns about physical functioning on the revised Physical Activity Readiness Questionnaire (PAR-Q; score 0)

Exclusion criteria

  • Diagnosed with dementia or neurodegenerative disease
  • Diagnosed with medical illness expected to worsen in the next 6 months
  • Diagnosed with serious untreated mental illness (i.e., schizophrenia) or untreated substance use disorder
  • Current suicidal ideation reported on self-report
  • Engaging in regular mindfulness practice > 45 min/week or has completed a course of cognitive behavioral therapy in the past 3 months
  • Regular use of a digital-monitoring device
  • Engagement in regular intensive physical exercise for >30 minute daily

Treatment and study plan

Active Brains 1

Behavioral

Active Brains 1 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 teach skills and strategies to manage early cognitive concerns and chronic pain. 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 wrist-worn digital monitoring device (ActiGraph) 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. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline 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 Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Primary outcomes

  1. Change in PROMIS Physical Function

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Change in rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function.

  2. Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.

  3. Change in six-minute walk test (6MWT)

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Assesses distance walked in 6 minutes.

Secondary outcomes

  1. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition.

  2. Everyday Cognition Scale (eCog-12)

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of participant's cognitively mediated functional abilities, with items ranging from 1-5. Scores are calculated by averaging the 12 items, and range from 1-5, with higher scores indicating greater cognitive decline.

  3. PROMIS Depression

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's negative mood, social cognition and views of self, with items ranging from 1-5. Higher T scores indicate higher levels of depression.

  4. PROMIS Anxiety

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's fear, anxious, hyperarousal and somatic symptoms pertaining to arousal, with items ranging from 1-5. Higher T scores indicate higher levels of anxiety.

  5. Numerical Rating Scale

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain.

Other outcomes

  1. Change in PROMIS Pain Interference - Short Form 6b V1.0

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Change in the self-reported consequences of pain on relevant aspects of a person's life, with items ranging from 0 to 5. Higher T scores indicate greater pain interference.

  2. Pain Catastrophizing Scale

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's hopelessness, helplessness, and rumination about pain, with items ranging from 0 to 4, total scores ranging from 0 to 52, and higher scores indicating higher levels of pain catastrophizing.

  3. Tampa Kinesiophobia Scale

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's fear of movement, with items ranging from 1-4, total scores ranging from 17 to 68, and higher scores indicating higher levels of fear of movement.

  4. Pain Self-Efficacy

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's confidence to do various activities despite their pain, with items ranging from 0-6, total scores ranging from 0-60, and a higher score showing greater levels of confidence with pain self-efficacy.

  5. Self-Compassion Scale

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's amount of self-compassion, with items ranging from 1-5. Scores are calculated by averaging the 12 items, and range from 1-5, with higher scores indicating higher levels of self-compassion.

  6. Measure of Current Status

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's self-reported perceived stress self-management skills, with items ranging from 0-4, total scores ranging from 0-52, and higher scores reflecting more usage of stress self-management skills.

  7. Gratitude Questionnaire

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's proneness to experience gratitude in daily life, with items ranging from 1-7, total scores ranging from 6-42, and a higher score indicating greater amount of gratitude.

  8. Toronto Mindfulness Scale

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's state mindfulness in the moment, with items ranging from 1-4, total scores ranging from 13-52, and a higher score indicating a greater amount of state-level mindfulness.

  9. NIH Toolbox Item Bank v2.0 - Loneliness (Ages 18+) - Fixed Form

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Measure of an individual's perceptions that one is alone, lonely, or socially isolated from others, with items ranging from 1-5. Higher T scores indicate a greater degree of loneliness.

  10. PROMIS Satisfaction with Social Roles and Activities

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's perceived satisfaction with social functioning, with items ranging from 1-5. Higher T scores indicate higher satisfaction with social functioning.

  11. Memory Compensation Questionnaire

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's use of cognitive compensatory strategies for actual or perceived memory loss, with items ranging from 0-4, total scores ranging from 0-52, and higher scores reflecting greater use of compensatory strategies.

  12. The Pain, Enjoyment of Life and General Activity (PEG) Scale

    Time frame: 1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks

    Rate of a participant's chronic pain level, measured by pain intensity and pain interference. Items range from 0-10, and total scores range from 0-30, with higher scores indicating greater levels of chronic pain.

  13. Global Cognitive and Social Engagement

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's perceived engagement in mentally stimulating social and cognitive activities, with items ranging from 0-4, total scores ranging from 0 to 20, and higher scores indicating higher perceived activity engagement.

  14. Quota-Based Pacing

    Time frame: 0 Weeks, 8 Weeks, 6 Months

    Rate of a participant's perceived use of quota-based activity pacing. Items range from 0-4, and total scores range from 0-16, with higher scores indicating greater use of quota-based pacing.

  15. Pain Interference Weekly Measure

    Time frame: 1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks

    Brief measure assessing the degree to which pain interferes with a participant's ability to meet their step count goal and degree to which it contributes to memory-related problems. Items range from 1-5, total scores range from 2-10, with higher scores indicating higher pain interference. Only administered to the Active Brains 1 group.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 13, 2022
Registry last updated
Jun 12, 2026

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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