N/A
N=21
Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain
Chronic Pain · Mild Cognitive Impairment · Older Adults · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT04044183 ↗Enrolled (actual)
21
Serious AEs
—
Results posted
Jul 2023
Primary outcome: Primary: Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint — 8; 9; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Brains 1 (Behavioral); Active Brains 2 (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint |
8; 9; 0; 1; 1; 1 | — |
| SECONDARY Proportion of Participants With Valid Digital Monitoring Device Wear |
8; 0; 1; 11 | — |
| SECONDARY Proportion of Participants With Valid Adherence to Homework |
8; 0; 1; 11 | — |
| SECONDARY Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills |
97.3; 91.4 | — |
| SECONDARY Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures) |
85; 99 | — |
| SECONDARY Proportion of Participants Using Rescue (Non-Narcotic) Analgesics |
4; 5 | — |
| SECONDARY Proportion of Participants Using Narcotic Analgesics |
2; 4 | — |
| SECONDARY Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint |
9; 11; 0; 0; 5; 4 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
24.8; 26.3; 26.2; 26.6 | — |
| SECONDARY Godin Leisure-Time Exercise Questionnaire |
36; 20; 74; 30.8 | — |
| SECONDARY Measure of Current Status (MOCS-A) |
30.4; 25.6; 36.1; 28.3 | — |
| SECONDARY The Measurement of Everyday Cognition (eCog) |
2.3; 1.9; 2; 1.8 | — |
| SECONDARY Numerical Rating Scale |
5.9; 4.4; 3.9; 4.3; 6.2; 5.7 | — |
| SECONDARY The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) |
31.9; 33.8; 33.9; 35.3 | — |
| SECONDARY WHO Disability Assessment Schedule 2.0 |
17.1; 23.9; 16; 22.2 | — |
| SECONDARY The Gratitude Questionnaire (GQ-6) |
36.2; 32.5; 35.5; 35.9 | — |
| SECONDARY PROMIS Physical Function |
39.9; 37.1; 43.4; 38.2 | — |
| SECONDARY PROMIS Emotional Support |
51.1; 49.4; 52.1; 48.8 | — |
| SECONDARY T-Score for PROMIS Depression |
51.6; 55.6; 52.5; 54.3 | — |
| SECONDARY T-Score for PROMIS Anxiety |
51; 52.9; 47.9; 53.7 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
9.4; 11.6; 7.1; 11 | — |
| SECONDARY UCLA Loneliness Scale |
12.9; 13.4; 12.6; 13.3 | — |
| SECONDARY Pain Self Efficacy Questionnaire (PSEQ) |
38; 35.5; 42.9; 38 | — |
| SECONDARY Tampa Kinesiophobia Scale |
31.9; 37.6; 31.2; 35.8 | — |
| SECONDARY Chronic Pain Acceptance Questionnaire |
30.1; 24.3; 31; 27.1 | — |
| SECONDARY Self-Compassion Scale (SCS) |
45.6; 44.4; 43.2; 43.6 | — |
| SECONDARY ActiGraph Average Steps |
3643.1; 3195.3; 4283.8; 2604.4 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
407.6; 415.6; 426.6; 435.2 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04044183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.