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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373745
• Other study ID #: 2021P00281
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: Ana-Maria Vranceanu, PhD
• Phone: 6176437996
• Email: avranceanu[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Cognitive Dysfunction
• Mild Cognitive Impairment
• Older Adults
• Physical Activity

Intervention

Behavioral:
• Active Brains 1
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
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Doorley JD, Mace RA, Popok PJ, Grunberg VA, Ragnhildstveit A, Vranceanu AM. Feasibility Randomized Controlled Trial of a Mind-Body Activity Program for Older Adults With Chronic Pain and Cognitive Decline: The Virtual "Active Brains" Study. Gerontologist. 2022 Aug 12;62(7):1082-1094. doi: 10.1093/geront/gnab135. — View Citation

Mace RA, Doorley JD, Popok PJ, Vranceanu AM. Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study. JMIR Res Protoc. 2021 Jan 4;10(1):e25351. doi: 10.2196/25351. — View Citation

Mace RA, Gates MV, Bullard B, Lester EG, Silverman IH, Quiroz YT, Vranceanu AM. Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Apr 3;61(3):449-459. doi: 10.1093/geront/gnaa084. — View Citation

Mace RA, Gates MV, Popok PJ, Kulich R, Quiroz YT, Vranceanu AM. Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Nov 15;61(8):1326-1337. doi: 10.1093/geront/gnaa179. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in PROMIS Pain Interference - Short Form 6b V1.0	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.	0 Weeks, 8 Weeks, 6 Months
Other	Pain Catastrophizing Scale	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.	0 Weeks, 8 Weeks, 6 Months
Other	Tampa Kinesiophobia Scale	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.	0 Weeks, 8 Weeks, 6 Months
Other	Pain Self-Efficacy	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.	0 Weeks, 8 Weeks, 6 Months
Other	Self-Compassion Scale	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.	0 Weeks, 8 Weeks, 6 Months
Other	Measure of Current Status	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.	0 Weeks, 8 Weeks, 6 Months
Other	Gratitude Questionnaire	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.	0 Weeks, 8 Weeks, 6 Months
Other	Toronto Mindfulness Scale	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.	0 Weeks, 8 Weeks, 6 Months
Other	NIH Toolbox Item Bank v2.0 - Loneliness (Ages 18+) - Fixed Form	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.	0 Weeks, 8 Weeks, 6 Months
Other	PROMIS Satisfaction with Social Roles and Activities	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.	0 Weeks, 8 Weeks, 6 Months
Other	Memory Compensation Questionnaire	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.	0 Weeks, 8 Weeks, 6 Months
Other	The Pain, Enjoyment of Life and General Activity (PEG) Scale	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.	1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks
Other	Global Cognitive and Social Engagement	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.	0 Weeks, 8 Weeks, 6 Months
Other	Quota-Based Pacing	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.	0 Weeks, 8 Weeks, 6 Months
Other	Pain Interference Weekly Measure	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.	1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks
Primary	Change in PROMIS Physical Function	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.	0 Weeks, 8 Weeks, 6 Months
Primary	Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer	Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.	0 Weeks, 8 Weeks, 6 Months
Primary	Change in six-minute walk test (6MWT)	Assesses distance walked in 6 minutes.	0 Weeks, 8 Weeks, 6 Months
Secondary	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition.	0 Weeks, 8 Weeks, 6 Months
Secondary	Everyday Cognition Scale (eCog-12)	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.	0 Weeks, 8 Weeks, 6 Months
Secondary	PROMIS Depression	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.	0 Weeks, 8 Weeks, 6 Months
Secondary	PROMIS Anxiety	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.	0 Weeks, 8 Weeks, 6 Months
Secondary	Numerical Rating Scale	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.	0 Weeks, 8 Weeks, 6 Months