Self-Management Program for Chronic Pain and Cognitive Impairment

(STEPS-CI Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

Disqualifiers: Serious acute illness, major surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.

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 data supports the effectiveness of the treatment STEPS-CI for chronic pain and cognitive impairment?

The research indicates that pain self-management training, a component of the STEPS-CI treatment, has been effective in increasing the use of relaxation and exercise/stretching in older adults with chronic pain, although it did not show significant differences in physical disability or pain intensity compared to an education-only group. This suggests that while the treatment may help improve coping strategies, more research is needed to confirm its overall effectiveness for chronic pain and cognitive impairment. ^{1 2 3 4 5}

Is the Self-Management Program for Chronic Pain and Cognitive Impairment safe for humans?

The safety of self-management programs for chronic pain, like the one studied in older adults, generally appears to be acceptable, as no significant safety concerns were reported in the trials. However, more research is needed to fully understand the safety and effectiveness of these programs, especially in older adults with chronic pain. ^{1 6 7 8 9}

How is the STEPS-CI treatment different from other treatments for chronic pain and cognitive impairment?

STEPS-CI is unique because it combines self-management techniques specifically tailored for individuals with both chronic pain and cognitive impairment, focusing on teaching pain coping skills and gradually increasing physical activity, such as walking, to improve overall well-being and potentially delay further cognitive decline. ^{1 10 11 12 13}

Eligibility Criteria

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)

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

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

Trial Timeline

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)

Treatment Details

Interventions

• STEPS-CI (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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 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 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]

References

1. United States 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]. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Instruments for the assessment of pain in older persons with cognitive impairment. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Pain assessment and cognitive impairment: part 2. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive complaints are associated with depression, fatigue, female sex, and pain catastrophizing in patients with chronic pain. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The silent epidemic of chronic pain in older adults. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Relationship between self-reported cognitive difficulties, objective neuropsychological test performance and psychological distress in chronic pain. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Chronic Pain Self-Management Program for Low-Income Patients: Themes from a Qualitative Inquiry. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Impact of a motivational intervention on coping with chronic pain: results of a controlled efficacy study]. [2021]

11. United States 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. [2022]

13. England 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. [2022]