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Positive Psychology for Chronic Pain Self-management

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive STEPS
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Usual care control group

Arm Description

Participants will engage in a 7-week positive psychology-based chronic pain self-management program.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 23, 2020
Last Updated
October 1, 2021
Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA), Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04321239
Brief Title
Positive Psychology for Chronic Pain Self-management
Official Title
Feasibility of a Technology-Enabled Chronic Pain Self-Management Intervention Delivered by Community Health Workers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA), Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will engage in a 7-week positive psychology-based chronic pain self-management program.
Arm Title
Usual care control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive STEPS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Interference
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in Self-reported Physical Functioning
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Participant Global Impression of Change--Pain
Description
How participant thinks their pain has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Time Frame
Baseline and 8 weeks
Title
Change in Pain Self-efficacy
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in Social Participation
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in Resilience
Description
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.
Time Frame
Baseline and 8 weeks
Title
Participant Global Impression of Change - Functioning
Description
How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Janevic, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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. 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.
IPD Sharing Time Frame
Data will be available for sharing upon the date of online publication of the results of the primary aims.
Citations:
PubMed Identifier
35394525
Citation
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.
Results Reference
derived

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Positive Psychology for Chronic Pain Self-management

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