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

NCT04044183 | Completed Results DMC

• 1 other identifier: 2018P002152
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Mild Cognitive Impairment; Older Adults; Physical Activity

Keywords

Chronic Pain; Mild Cognitive Impairment; Older Adults; Physical Activity; Memory Related Problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Proportion of Participants With Valid Digital Monitoring Device Wear

  0 Weeks, 8 Weeks

• Proportion of Participants With Valid Adherence to Homework

  0 Weeks, 8 Weeks

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

  0 Weeks, 8 Weeks

• Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)

  0 Weeks, 8 Weeks

• Proportion of Participants Using Rescue (Non-Narcotic) Analgesics

  0 Weeks

Study Arms (2)

Active Brains

EXPERIMENTAL

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.

Behavioral: Active Brains 1; Behavioral: Active Brains 2

Active Brains 2

PLACEBO COMPARATOR

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.

Behavioral: Active Brains 1; Behavioral: Active Brains 2

Interventions

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; Active Brains 2

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.

Active Brains; Active Brains 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 34487167 DERIVED

• 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.

  PMID: 33208301 DERIVED

MeSH Terms

Conditions

Chronic Pain; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Ana-Maria Vranceanu
• Organization: Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital

avranceanu@mgh.harvard.edu

(617) 724-3953

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Director

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: September 15, 2019
• Primary Completion: December 21, 2020
• Study Completion: June 30, 2021
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)