Chronic PainMY-SkillsNCT03440320
Online Education and Gentle Exercise Intervention
A study testing MY-SKILLS - online in people with Chronic Pain and Pain, run by Colorado State University at 1 site in United States.
Trial summary
Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Pain
- What is being tested?
- MY-SKILLS - online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to 12 May 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both members of the caregiving dyad:
- Chronic musculoskeletal pain, present for a minimum of three months
- Moderate or high levels of daily pain-related disability (BPI ≥ 5)
- Part of caregiving dyad
- Adults age 18 and over and able to speak English
- Score >4 out of 6 on the short Mini Mental Status Exam
Show all 11Show fewer
- Ability to stand with or without an assistive device
- Sedentary lifestyle (i.e., any waking behavior characterized by an energy expenditure ≤1.5 metabolic equivalents while in a sitting or reclining posture)
- -Living at home in the community (with or without caregiver)
- Identified as the primary caregiver
- Caregiver at least the past six months
Who cannot join
- Significant cardiovascular disease: New York Heart Association functional class 3 or 4 congestive heart failure; systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 105 mmHg; myocardial infarction within 3 months, chest pain or dizziness with exercise
- Stroke, or Transient Ischemic Attack within 6 months
- Respiratory conditions requiring use of oxygen at home (i.e., COPD)
- Receiving or planning to receive, cancer treatment in the next 6 months
- Alzheimer's disease, dementia; expectation of death in the next 12 months
- In current physical rehabilitation, drug/alcohol treatment, or exercise research study
- Completed self-management education in the last year
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group.
Aim 2: Assess feasibility and acceptability of an online intervention, the Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will include 30 caregiving dyads randomly assigned to the two groups (15 dyads for Education and Gentle Exercise, and 15 dyads for control group; N = 30 dyads/60 participants). The primary hypothesis is that Education and Gentle Exercise will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities.
Read the detailed description
The long-term goal of this study is to advance best practices in complementary and integrative health (CIH) to improve health for caregivers and individuals with chronic disabilities. This proposal is focused on merging exercise and education to improve pain for individuals in a caregiving dyad. The objective of this study is to develop and test the online Education and Gentle Exercise intervention, thus, addressing the critical need for innovative pain interventions focusing on the caregiving dyad. To achieve this objective and support a future randomized controlled trial (RCT), the researchers will conduct a mixed-methods study, including a small RCT.
Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group.
Aim 2: Assess feasibility and acceptability of online Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will be assigned to one of the the two groups. The primary hypothesis is that the online Education and Gentle Exercise intervention will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted online to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities. To assess change on the primary outcome (pain-related disability) and secondary outcome measures, members of the caregiving dyad will complete pre and post-assessments guided by the Biopsychosocial model.
- Conditions
- Chronic Pain, Pain
- Being tested
- MY-SKILLS - online, MY-Plan control - online
- Keywords
- Caregiving Dyad, Pain-related Disability
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY-SKILLS - onlineBehavioural
Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain
MY-Plan control - onlineBehavioural
Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..
| Study group | Role | What they receive |
|---|---|---|
| MY-Skills Intervention - online | Experimental | Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain. Receives: Behavioral: MY-SKILLS - online |
| MY-Plan control - online | Active comparator | Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain. Receives: Behavioral: MY-Plan control - online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Change from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity and interference.
Caregiver and care receiver completed the assessment on their own pain.
Measured: Administered at baseline and again following the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start29 Mar 2018
- Primary completion12 May 2021
- Study completion12 May 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Model description
- Online intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Arlene Schmid, Colorado State University
- Investigators
- Arlene Schmid, PhD, Principal investigator, Colorado State UniversityChristine Fruhauf, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440320
- Sponsor's protocol ID
- 17-7581H
- Other IDs
- R34AT009688
- Acronym
- MY-Skills
- Status last verified
- Jun 2025
- First submitted
- 31 Jan 2018
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmid AA, Fruhauf CA, Fox AL, Sharp JL, Portz JD, Leach HJ, Van Puymbroeck M. A pilot study to establish feasibility and acceptability of a yoga and self-management education intervention to support caregivers and care receivers with persistent pain. Front Rehabil Sci. 2024 Oct 3;5:1397220. doi: 10.3389/fresc.2024.1397220. eCollection 2024.
PubMed 39421567Portz JD, Schmid A, Fruhauf C, Fox A, Van Puymbroeck M, Sharp J, Leach H. Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study. JMIR Form Res. 2023 May 24;7:e39158. doi: 10.2196/39158.
PubMed 37223971
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Education and Gentle Exercise Intervention
- ClinicalTrials.gov ID
- NCT03440320
- Acronym / sponsor ID
- MY-Skills / 17-7581H
- Conditions
- Chronic Pain, Pain
- Keywords
- Caregiving Dyad, Pain-related Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group.
Aim 2: Assess feasibility and acceptability of an online intervention, the Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will include 30 caregiving dyads randomly assigned to the two groups (15 dyads for Education and Gentle Exercise, and 15 dyads for control group; N = 30 dyads/60 participants). The primary hypothesis is that Education and Gentle Exercise will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities.
Detailed description
The long-term goal of this study is to advance best practices in complementary and integrative health (CIH) to improve health for caregivers and individuals with chronic disabilities. This proposal is focused on merging exercise and education to improve pain for individuals in a caregiving dyad. The objective of this study is to develop and test the online Education and Gentle Exercise intervention, thus, addressing the critical need for innovative pain interventions focusing on the caregiving dyad. To achieve this objective and support a future randomized controlled trial (RCT), the researchers will conduct a mixed-methods study, including a small RCT.
Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group.
Aim 2: Assess feasibility and acceptability of online Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will be assigned to one of the the two groups. The primary hypothesis is that the online Education and Gentle Exercise intervention will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted online to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities. To assess change on the primary outcome (pain-related disability) and secondary outcome measures, members of the caregiving dyad will complete pre and post-assessments guided by the Biopsychosocial model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Online intervention
| Arm | Type | Receives |
|---|---|---|
| MY-Skills Intervention - online | Experimental | Behavioral: MY-SKILLS - onlineParticipants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain. |
| MY-Plan control - online | Active comparator | Behavioral: MY-Plan control - onlineParticipants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Chronic musculoskeletal pain, present for a minimum of three months
- Moderate or high levels of daily pain-related disability (BPI ≥ 5)
- Part of caregiving dyad
- Adults age 18 and over and able to speak English
- Score >4 out of 6 on the short Mini Mental Status Exam
Key exclusion criteria (7 listed)
- Significant cardiovascular disease: New York Heart Association functional class 3 or 4 congestive heart failure; systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 105 mmHg; myocardial infarction within 3 months, chest pain or dizziness with exercise
- Stroke, or Transient Ischemic Attack within 6 months
- Respiratory conditions requiring use of oxygen at home (i.e., COPD)
- Receiving or planning to receive, cancer treatment in the next 6 months
- Alzheimer's disease, dementia; expectation of death in the next 12 months
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 |
|---|---|---|
| MY-SKILLS - onlineParticipants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain | Behavioural | MY-Skills Intervention - online |
| MY-Plan control - onlineParticipants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain.. | Behavioural | MY-Plan control - online |
Primary outcome
Brief Pain Inventory
Time frame: Administered at baseline and again following the 8-week intervention
Change from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity and interference. Caregiver and care receiver completed the assessment on their own pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39421567Schmid AA, Fruhauf CA, Fox AL, Sharp JL, Portz JD, Leach HJ, Van Puymbroeck M. A pilot study to establish feasibility and acceptability of a yoga and self-management education intervention to support caregivers and care receivers with persistent pain. Front Rehabil Sci. 2024 Oct 3;5:1397220. doi: 10.3389/fresc.2024.1397220. eCollection 2024.
- Derived from this study: PubMed 37223971Portz JD, Schmid A, Fruhauf C, Fox A, Van Puymbroeck M, Sharp J, Leach H. Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study. JMIR Form Res. 2023 May 24;7:e39158. doi: 10.2196/39158.
- Individual participant dataSharing planned: No
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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.
Arlene Schmid, PhD principal investigator
Colorado State University
Christine Fruhauf, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MY-SKILLS - online in people with Chronic Pain and Pain, run by Colorado State University 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 11 inclusion and 7 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 13 Jun 2025. 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 9 Jul 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?
Brief Pain Inventory (time frame: Administered at baseline and again following the 8-week intervention). 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 NCT03440320, which also lists 2 linked publications.
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 13 Jun 2025.