18 and older, any sex, with Chronic Pain or Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Brief Pain InventoryPrimary· 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.
Online Pilot, MY-Skills (Intervention), Care Receivers
-0.29
± 1.63
Online Pilot, MY-PLAN (Control), Caregivers
-1.38
± 1.83
Online Pilot, MY-PLAN (Control), Care Receivers
-1.32
± 1.87
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 months, the span of time we conducted every intervention cohort.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Colorado State University
Last refreshed: 13 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03440320.