Online Education and Gentle Exercise Intervention

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 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.

Conditions

• Chronic Pain
• Pain

Interventions

BEHAVIORAL

MY-SKILLS - online

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

BEHAVIORAL

MY-Plan control - online

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..

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Colorado State University

  lead OTHER

Principal Investigators

• Arlene Schmid, PhD · Colorado State University

• Christine Fruhauf, PhD · Colorado State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-29

Primary Completion

2021-05-12

Completion

2021-05-12

Countries

• United States

Study Locations