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

Mass General Brigham

Status: Completed

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

Treatments: Behavioral: Active Brains 2; Behavioral: Active Brains 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04044183

2018P002152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups, including a placebo group

Active Brains

Experimental group

Description:

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.

Treatment:

Behavioral: Active Brains 2

Behavioral: Active Brains 1

Active Brains 2

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Active Brains 2

Behavioral: Active Brains 1