Self-Management Program for Chronic Pain and Cognitive Impairment

(STEPS-CI Trial)

Overseen By Mary Janevic, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Serious acute illness, major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called STEPS-CI, designed to help individuals manage chronic pain while dealing with memory issues that interfere with daily life. Participants will learn self-management skills through weekly phone sessions with a health worker and educational videos. The goal is to determine if this program can reduce the impact of pain on daily activities. Suitable candidates have experienced muscle or joint pain for over three months, find that pain sometimes hinders daily tasks, and have mild memory problems. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance daily life for those with chronic pain and memory issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on self-management techniques rather than medication changes.

What prior data suggests that this self-management program is safe for people with chronic pain and cognitive impairment?

Research shows that self-management programs for chronic pain, such as STEPS-CI, are generally safe and manageable. Studies have found that participants in similar programs experienced improved physical and mental abilities. For instance, one study found that participants reported less pain and reduced interference with daily activities after completing the program. No major negative effects were reported, indicating the program's safety for individuals with chronic pain and cognitive difficulties. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STEPS-CI program because it offers a fresh approach to managing chronic pain and cognitive impairment. Unlike traditional treatments that often rely on medication or intensive therapy, STEPS-CI empowers participants through self-management. It combines educational videos with weekly sessions led by a community health worker, fostering a more personal and interactive learning experience. This method not only addresses physical symptoms but also incorporates cognitive components, aiming to enhance overall quality of life.

What evidence suggests that the STEPS-CI program is effective for managing chronic pain and cognitive impairment?

Research has shown that self-management programs for chronic pain can be helpful. In this trial, participants in the STEPS-CI Intervention Group will engage in organized self-management activities, including watching educational videos and attending weekly sessions with a community health worker. Studies have found that such programs often reduce the interference of pain in daily life. Previous trials with similar programs showed good results in reducing pain and improving quality of life. Participants in these programs usually receive educational materials and support, aiding in better pain management. While results can vary, overall evidence suggests these programs are promising for people dealing with both chronic pain and cognitive challenges. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for older adults over 50 with chronic muscle or joint pain and mild cognitive issues that affect daily life. Participants need phone and internet access, speak English, and be open to learning new pain management methods via weekly calls or videos.

Inclusion Criteria

Have a cell or landline phone and internet access

I am over 50 years old.

I experience memory problems that sometimes affect my daily activities.

Exclusion Criteria

Other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder)

Current or prior participation in the parent STEPS study or the RESET (Re-Engaging in Self-Care and Enjoying Today) Study.

I haven't been seriously ill or hospitalized in the last month and don't have major surgery planned in the next three months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group receive education and support from a community health worker in 7 weekly telephone sessions and watch educational videos on chronic pain self-management.

7 weeks

7 visits (telephone)

Follow-up

Participants are monitored for changes in pain interference and cognitive functioning after the treatment phase.

3 weeks

1 visit (telephone)

Control Group Post-Study Session

Control group members are invited to a virtual workshop covering key STEPS-CI content and receive program materials.

1 session

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• STEPS-CI

Trial Overview The STEPS-CI program is being tested to see if it helps people manage chronic pain better through education and support from a health worker over seven weeks of phone sessions, compared to a control group who receive a summary session after the study.

How Is the Trial Designed?

Group I: STEPS-CI Intervention Group Experimental Treatment 1 Intervention

Participants will engage in a behavioral intervention for chronic pain self-management that includes watching brief educational videos on a website and weekly sessions with a community health worker.

Group II: STEPS-CI Control Group Active Control 1 Intervention

Members of the control group will not receive the STEPS-CI intervention. After completing the 8-week follow-up telephone survey, control group members will be invited to take part in a virtual workshop covering key STEPS-CI content and will receive program materials.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The study evaluated a multi-dimensional tool for assessing pain in cognitively impaired adults, revealing that certain pain indicators were more frequently observed and documented, particularly during morning shifts.

Nurses' compliance in recording pain observations was inconsistent, highlighting the need for better training and support to enhance pain assessment practices, which should combine physiological and behavioral indicators based on clinical judgment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain assessment and cognitive impairment: part 2. Davies, E., Male, M., Reimer, V., et al.[2019]

A randomized controlled trial involving 256 older adults (average age 81.8) found that pain self-management training did not significantly improve physical disability or other outcomes compared to an education-only control group.

However, participants in the self-management group reported greater increases in relaxation and exercise/stretching techniques, suggesting that while overall effectiveness was not established, the training may enhance coping strategies for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a randomized controlled trial to examine the efficacy of a chronic pain self-management group for older adults [ISRCTN11899548]. Ersek, M., Turner, JA., Cain, KC., et al.[2021]

The Chronic Pain Self-Management Programme (CPSMP) was found to be feasible and well-received by participants, with over 75% recommending it to others, indicating its potential for broader implementation.

Participants in the CPSMP experienced significant and stable improvements in pain, disability, and psychological factors like anxiety and depression over a 5-month follow-up, although the overall changes were modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. Mehlsen, M., Heegaard, L., Frostholm, L.[2022]

The Stanford Chronic Pain Self-Management Programme (CPSMP) did not significantly reduce pain-related disability or healthcare costs in a study of 424 adults with chronic pain, indicating it may not be an effective treatment for this issue.

While there were small improvements in emotional distress and illness worry three months after the program, these changes were clinically insignificant, suggesting that the CPSMP may not provide meaningful benefits for individuals suffering from chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a lay-led, group-based self-management program for patients with chronic pain: a randomized controlled trial of the Danish version of the Chronic Pain Self-Management Programme. Mehlsen, M., Hegaard, L., Ørnbøl, E., et al.[2023]

A randomized non-inferiority trial is being conducted with 230 patients suffering from chronic low back pain to compare the effectiveness of traditional in-person cognitive behavioral therapy (CBT) with an innovative interactive voice response (IVR)-based CBT, aiming to enhance access to treatment.

The primary goal is to assess pain intensity immediately after treatment, while secondary outcomes will evaluate pain-related interference, emotional functioning, and quality of life over time, potentially demonstrating that IVR-based CBT can effectively provide care to more patients without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. Heapy, AA., Higgins, DM., LaChappelle, KM., et al.[2022]

The Living Better Beyond Pain (LBBP) program showed clinically significant improvements in daily function and reduced reliance on pain medication among participants, highlighting its efficacy in chronic pain self-management.

Factors influencing participation included dissatisfaction with current pain management, social support from peers, and the need for training, while barriers such as transportation and competing activities were noted, suggesting areas for program improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Pain Self-Management Program for Low-Income Patients: Themes from a Qualitative Inquiry. Turner, BJ., Rodriguez, N., Bobadilla, R., et al.[2021]

In a study of 222 chronic pain patients, factors such as depressive symptoms, fatigue, and pain catastrophizing were found to significantly contribute to complaints of cognitive dysfunction, accounting for 52% of the variance in cognitive difficulties reported.

The study highlighted that female patients with chronic pain are particularly vulnerable to cognitive impairment, indicating a need for targeted interventions that address these specific psychosocial factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive complaints are associated with depression, fatigue, female sex, and pain catastrophizing in patients with chronic pain. Roth, RS., Geisser, ME., Theisen-Goodvich, M., et al.[2022]

A review of 30 pain measurement instruments for cognitively impaired older adults revealed that none had comprehensive reliability and validity data, highlighting a significant gap in effective pain assessment tools for this population.

The study emphasizes the urgent need for the development and rigorous testing of reliable and valid pain assessment instruments to improve pain management in older individuals with cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instruments for the assessment of pain in older persons with cognitive impairment. Stolee, P., Hillier, LM., Esbaugh, J., et al.[2008]

Both mind-body activity programs, Active Brains and Active Brains-Fitbit, were feasible for older adults with chronic pain and cognitive decline, showing improvements in pain intensity, coping, physical function, and cognitive function among participants.

Participants expressed high satisfaction with both programs, indicating that these interventions could be beneficial for enhancing the quality of life in older adults facing chronic pain and cognitive challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. Mace, RA., Gates, MV., Popok, PJ., et al.[2022]

In a study of 41 chronic pain patients, self-reported cognitive concerns were found to align with objective neuropsychological test performance, indicating that patients' perceptions of their cognitive abilities are valid and should be taken seriously.

Higher levels of anxiety were associated with stronger correlations between subjective cognitive complaints and objective performance, suggesting that anxiety may enhance patients' awareness of their cognitive deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between self-reported cognitive difficulties, objective neuropsychological test performance and psychological distress in chronic pain. Baker, KS., Gibson, SJ., Georgiou-Karistianis, N., et al.[2019]

A mixed-methods study involving 23 older adults with chronic pain and cognitive decline identified key themes related to their experiences and preferences for a new mind-body activity program aimed at increasing walking, highlighting the importance of tailored interventions.

Participants showed lower physical functioning compared to norms, but higher self-efficacy was linked to better cognitive, emotional, and physical functioning, suggesting that boosting self-efficacy could enhance the effectiveness of the proposed programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. Mace, RA., Gates, MV., Bullard, B., et al.[2022]

A study involving 147 patients with chronic pain conditions showed that brief motivational interviewing by telephone significantly improved cognitive coping and emotional coping related to anxiety and anger over a 9-month period.

While the intervention did not significantly enhance self-efficacy or behavioral coping, it was particularly effective for patients with rheumatoid arthritis and ankylosing spondylitis compared to those with fibromyalgia syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of a motivational intervention on coping with chronic pain: results of a controlled efficacy study]. Rau, J., Ehlebracht-König, I., Petermann, F.[2021]

Chronic pain is very common in older adults and can lead to serious issues like disability, social isolation, and increased healthcare costs, but current pharmaceutical treatments often have limited effectiveness and significant side effects.

There is a lack of research on how chronic pain treatments affect older adults, particularly regarding the risks of polypharmacy and frailty, highlighting the need for future studies to develop safer and more effective pain management strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The silent epidemic of chronic pain in older adults. Domenichiello, AF., Ramsden, CE.[2020]

Citations

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Chronic Pain Self-management for Older Adults With ... The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0304395911006269

A randomized controlled evaluation of an online chronic ... Results indicated that program utilization was associated with significant decreases in pain severity, pain-related interference and emotional burden, perceived ...