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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044183
• Other study ID #: 2018P002152
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 30, 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint	Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction	8 Weeks
Secondary	Proportion of Participants With Valid Digital Monitoring Device Wear	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	0 Weeks, 8 Weeks
Secondary	Proportion of Participants With Valid Adherence to Homework	Proportion of participants completing at least 5 out of 7 days of homework assigned throughout the study	0 Weeks, 8 Weeks
Secondary	Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills	Percentage of audio recordings, progress notes, and checklists that were completed with 100% of content delivered for each session	0 Weeks, 8 Weeks
Secondary	Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)	Percentage of questionnaires that were entirely missing in >25% of participants and/or had an internal reliability below .70	0 Weeks, 8 Weeks
Secondary	Proportion of Participants Using Rescue (Non-Narcotic) Analgesics	Single-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline	0 Weeks
Secondary	Proportion of Participants Using Narcotic Analgesics	Single-item question on demographics form indicating whether participant used narcotic analgesics at baseline	0 Weeks
Secondary	Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint	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	0 Weeks
Secondary	Montreal Cognitive Assessment (MoCA)	Assesses several cognitive domains and detection of mild cognitive impairment (MCI), with scores ranging from 0-30 and lower scores indicating greater cognitive decline	0 Weeks, 8 Weeks
Secondary	Godin Leisure-Time Exercise Questionnaire	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.	0 Weeks, 8 Weeks
Secondary	Measure of Current Status (MOCS-A)	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	0 Weeks, 8 Weeks
Secondary	The Measurement of Everyday Cognition (eCog)	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.	0 Weeks, 8 Weeks
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 the worst possible pain	0 Weeks, 8 Weeks
Secondary	The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)	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	0 Weeks, 8 Weeks
Secondary	WHO Disability Assessment Schedule 2.0	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	0 Weeks, 8 Weeks
Secondary	The Gratitude Questionnaire (GQ-6)	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	0 Weeks, 8 Weeks
Secondary	PROMIS Physical Function	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	0 Weeks, 8 Weeks
Secondary	PROMIS Emotional Support	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.	0 Weeks, 8 Weeks
Secondary	T-Score for PROMIS Depression	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.	0 Weeks, 8 Weeks
Secondary	T-Score for PROMIS Anxiety	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.	0 Weeks, 8 Weeks
Secondary	Pain Catastrophizing Scale (PCS)	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	0 Weeks, 8 Weeks
Secondary	UCLA Loneliness Scale	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	0 Weeks, 8 Weeks
Secondary	Pain Self Efficacy Questionnaire (PSEQ)	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	0 Weeks, 8 Weeks
Secondary	Tampa Kinesiophobia Scale	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	0 Weeks, 8 Weeks
Secondary	Chronic Pain Acceptance Questionnaire	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	0 Weeks, 8 Weeks
Secondary	Self-Compassion Scale (SCS)	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	0 Weeks, 8 Weeks
Secondary	ActiGraph Average Steps	Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.	0 weeks, 8 weeks
Secondary	Six-Minute Walk Test (6MWT)	The Six-Minute Walk Test (6MWT) measures the distances participants can walk at an accelerated pace in meters over a 6-minute span.	0 weeks, 8 weeks