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Positive Psychology for Chronic Pain Self-management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321239
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Mary Janevic, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Positive STEPS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Positive Psychology for Chronic Pain Self-management
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intervention group
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Behavioral: Positive STEPS
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.

No Intervention: Usual care control group
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.



Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Participant Global Impression of Change [ Time Frame: Baseline and 8 weeks ]
    Two items: 1) How participant thinks their pain has changed from baseline (much worse (-3) to much better(+3)). 2) How participant thinks their functioning has changed from baseline (much worse (-3) to much better(+3)).

  2. Change in pain self-efficacy [ Time Frame: Baseline and 8 weeks ]
    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.

  3. Change in social participation [ Time Frame: Baseline and 8 weeks ]
    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

  4. Change in resilience [ Time Frame: Baseline and 8 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321239


Contacts
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Contact: Mary Janevic, PhD 734 647 3194 mjanevic@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mary Janevic, PhD         
Sponsors and Collaborators
University of Michigan
National Institute on Aging (NIA)
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Mary Janevic, PhD University of Michigan
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Responsible Party: Mary Janevic, Associate Research Scientist, University of Michigan
ClinicalTrials.gov Identifier: NCT04321239    
Other Study ID Numbers: HUM00162275
2P30AG022845-16 ( U.S. NIH Grant/Contract )
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available for sharing upon the date of online publication of the results of the primary aims.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms