Chronic PainNCT04321239

Positive Psychology for Chronic Pain Self-management

A study testing Positive STEPS in people with Chronic Pain, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Positive STEPS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 14 May 2020to 22 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

English-proficient
Ambulatory with or without assistive device
Community-living
Have a cell or landline phone
Have Internet access (home or elsewhere);
Self-reported chronic musculoskeletal pain (pain in muscles or joints for > 3 months); >4 (0-10 scale) average pain level over last week; >1 day/previous 30 when pain made it difficult to do usual activities.

Who cannot join

Serious acute illness or hospitalization in last month
Planned surgery in next three months
Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Feasibility of a Technology-Enabled Chronic Pain Self-Management Intervention Delivered by Community Health Workers

Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a randomized pilot and feasibility trial of a positive psychology-based chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 50 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.

Conditions: Chronic Pain
Being tested: Positive STEPS
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positive STEPSBehavioural
Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They can choose to report daily step counts either by automatically syncing to an app or by manual reporting via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants will also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.

Study groups in NCT04321239
Study group	Role	What they receive
Intervention group	Experimental	Participants will engage in a 7-week positive psychology-based chronic pain self-management program. Receives: Behavioral: Positive STEPS
Usual care control group	No intervention	After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Interference
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome.
Measured: Baseline and 8 weeks
Change in Self-reported Physical Functioning
The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.
Measured: Baseline and 8 weeks

Secondary outcomes (5)

Participant Global Impression of Change--Pain
How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Measured: Baseline and 8 weeks
Change in Pain Self-efficacy
The Pain Self-Efficacy Questionnaire, a 10-item scale (Nicholas 1989) rating confidence at doing specific things (e.g., chores, accomplishing goals, becoming more active) despite pain; each item scored from 0=not at all confident to 6=completely confident.
Measured: Baseline and 8 weeks
Change in Social Participation
Ability to Participate in Social Roles and Activities, a 4-item subscale from PROMIS-20 rating the amount of trouble (1=not at all to 5=very much) in participating in social roles such as family activities, leisure activities, and work. Raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 29 to 64, with a higher score representing worse outcome.
Measured: Baseline and 8 weeks
Change in Resilience
10-item version of the Connor-Davidson resilience scale rating the degree (0=not true at all to 4=true nearly all the time) respondent can cope/be resilient in various situations. Higher score means more resilience.
Measured: Baseline and 8 weeks
Participant Global Impression of Change - Functioning
How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 202022 Dec 2020

First posted25 Mar 2020
Study start14 May 2020
Primary completion22 Dec 2020
Study completion22 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04321239
Sponsor's protocol ID: HUM00162275
Other IDs: 2P30AG022845-16
Status last verified: Oct 2021
First submitted: 23 Mar 2020
Last updated: 1 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 1. Self-reported survey data (baseline and 8 weeks from baseline) on pain and functioning, as well as other health and demographic information from a telephone survey of 50 pilot study participants. For 25 of these participants, we will also have up to six weeks of daily activity (step count) data. Two anonymized datasets will be created: 1) survey data only; 2) survey data plus, for the subset of 25 participants, activity data linked to survey data. In order to maintain confidentiality, outliers, dates, and personal identifiers will be removed from the data set. 2. Notes from post-program qualitative interviews (n=25). These are in-depth, semi-structured interviews about challenges, facilitators, and satisfaction with various aspects of the program and its implementation. We will share de-identified copies of detailed notes from these interviews (we do not plan on producing verbatim transcripts) but not audiorecordings.

Publications

Janevic M, Robinson-Lane SG, Courser R, Brines E, Hassett AL. A Community Health Worker-Led Positive Psychology Intervention for African American Older Adults With Chronic Pain. Gerontologist. 2022 Oct 19;62(9):1369-1380. doi: 10.1093/geront/gnac010.
PubMed 35394525

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of a Technology-Enabled Chronic Pain Self-Management Intervention Delivered by Community Health Workers
ClinicalTrials.gov ID: NCT04321239
Acronym / sponsor ID: HUM00162275
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Weill Medical College of Cornell University
Study start: 14 May 2020 (actual)
Primary completion: 22 Dec 2020 (actual)
Study completion: 22 Dec 2020 (actual)
First posted: 25 Mar 2020 (actual)
Results: Posted 1 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Behavioral: Positive STEPSParticipants will engage in a 7-week positive psychology-based chronic pain self-management program.
Usual care control group	No intervention	–After completing the follow-up telephone survey, individuals in the control condition will be given access to the online program, a wearable physical activity tracker to use and keep, and will be invited to attend a one-time 2.5-hour in-person or telephone workshop that summarizes intervention content and that will be led jointly by study staff and a community health worker.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

English-proficient
Ambulatory with or without assistive device
Community-living
Have a cell or landline phone
Have Internet access (home or elsewhere);

Key exclusion criteria (3 listed)

Serious acute illness or hospitalization in last month
Planned surgery in next three months
Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Positive STEPSIndividuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They can choose to report daily step counts either by automatically syncing to an app or by manual reporting via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants will also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.	Behavioural	Intervention group

Primary outcome

Change in Pain Interference
Time frame: Baseline and 8 weeks
The Pain Interference 6-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Adult Profile. Items ask how much pain in the last 7 days has interfered with daily activities such as household chores and social activities (1=not at all to 5=very much); raw total scale scores range from 6 (low interference) to 30 (high interference). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 42 to 76, with a higher score representing worse outcome.
Change in Self-reported Physical Functioning
Time frame: Baseline and 8 weeks
The Physical Functioning 4-item subscale of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Adult Profile. Items ask how much difficulty participant has in doing daily activities such as household chores, using stairs, and walking 15 minutes (1=without any difficulty to 5=unable to do); raw total scale scores range from 4 (high functioning) to 20 (low functioning). When converted to T-scores (normed such that a score of 50 is the population mean and 10 T-score points=1 standard deviation), the possible range is 23 to 57, with a higher score representing worse outcome.

5 secondary outcomes

Participant Global Impression of Change--Pain
Time frame: Baseline and 8 weeks
Change in Pain Self-efficacy
Time frame: Baseline and 8 weeks
Change in Social Participation
Time frame: Baseline and 8 weeks
Change in Resilience
Time frame: Baseline and 8 weeks
Participant Global Impression of Change - Functioning
Time frame: 8 weeks

Results and safety

Results posted to the registry on 1 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	25	22
Usual Care Control Group	26	24

Primary outcome: Change in Pain Interference

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: T-score

Measure	Intervention Group n = 21	Usual Care Control Group n = 23
Value	-3.82 (5.2)	.32 (5.0)

Population analysed: Participants who had data on both baseline and follow-up measure. Change score is the follow-up minus baseline score, such that a greater, negative change value is a better outcome.

Primary outcome: Change in Self-reported Physical Functioning

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: T-score

Measure	Intervention Group n = 22	Usual Care Control Group n = 24
Value	43.7 (7.7)	40.9 (6.3)

Population analysed: Participants who had both baseline and follow-up data on this measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Two months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	2 of 25 (8%)	0 of 25 (0%)	0 of 25
Usual Care Control Group	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35394525Janevic M, Robinson-Lane SG, Courser R, Brines E, Hassett AL. A Community Health Worker-Led Positive Psychology Intervention for African American Older Adults With Chronic Pain. Gerontologist. 2022 Oct 19;62(9):1369-1380. doi: 10.1093/geront/gnac010.
Individual participant dataSharing planned: Yes. 1. Self-reported survey data (baseline and 8 weeks from baseline) on pain and functioning, as well as other health and demographic information from a telephone survey of 50 pilot study participants. For 25 of these participants, we will also have up to six weeks of daily activity (step count) data. Two anonymized datasets will be created: 1) survey data only; 2) survey data plus, for the subset of 25 participants, activity data linked to survey data. In order to maintain confidentiality, outliers, dates, and personal identifiers will be removed from the data set. 2. Notes from post-program qualitative interviews (n=25). These are in-depth, semi-structured interviews about challenges, facilitators, and satisfaction with various aspects of the program and its implementation. We will share de-identified copies of detailed notes from these interviews (we do not plan on producing verbatim transcripts) but not audiorecordings.

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Recruiting
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Not yet recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Janevic, PhD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Positive STEPS in people with Chronic Pain, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Interference (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.