Merging Yoga and Self-Management to Develop Skills



Status:Recruiting
Conditions:Chronic Pain, Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:5/11/2018
Start Date:March 29, 2018
End Date:December 31, 2020
Contact:Arlene Schmid, PhD
Email:arlene.schmid@colostate.edu
Phone:(970) 491-7562

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Aim 1: Develop and manualize the MY-Skills 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 MY-Skills
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 MY-Skills
intervention workbooks for participants and training and teaching manuals for
interventionists leading the MY-Skills intervention group and control group.

Aim 2: Assess feasibility and acceptability of MY-Skills and research procedures including
planned assessments. In this small RCT, the researchers will examine feasibility and
acceptability of the 8-week MY-Skills 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 My-Skills and 15 dyads for control group; N
= 30 dyads/60 participants). The primary hypothesis is that MY-Skills 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
MY-Skills. After each intervention session, interventionists, caregivers, and care recipients
will rate their satisfaction with the session content and activities.

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
MY-Skills 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 MY-Skills 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 MY-Skills
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 MY-Skills
intervention workbooks for participants and training and teaching manuals for
interventionists leading the MY-Skills intervention group and control group.

Aim 2: Assess feasibility and acceptability of MY-Skills and research procedures including
planned assessments. In this small RCT, the researchers will examine feasibility and
acceptability of the 8-week MY-Skills 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 My-Skills and 15 dyads for control group; N
= 30 dyads/60 participants). The primary hypothesis is that MY-Skills 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
MY-Skills. 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.

Inclusion Criteria:

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

- 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)

Inclusion for care recipient only:

-Living at home in the community (with or without caregiver)

Inclusion for caregiver only:

- Identified as the primary caregiver

- Caregiver at least the past six months

Exclusion Criteria:

- 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
We found this trial at
1
site
Fort Collins, Colorado 80523
Principal Investigator: Christine A Fruhauf, PhD
Phone: 970-491-7562
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mi
from
Fort Collins, CO
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