Chronic Pain
Conditions
Keywords
chronic pain, mindfulness, complementary therapies, models, biopsychosocial, rural Veterans health
Brief summary
This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3), the investigators will conduct a single-arm pilot study of 40 rural VA patients with chronic pain to assess study feasibility (recruitment and retention), intervention feasibility (fidelity of intervention delivery and participant engagement rates), acceptability, and effectiveness at addressing pre-defined capabilities, opportunities and motivations.
Detailed description
Pain is a complex biophysical, psychological, and social condition and there is a growing evidence base to support several complementary and integrative health (CIH) approaches, which can address pain in a more holistic way. While the VA has become a leader in advancing CIH through its Whole Health Initiative, there remain many barriers, especially for rural patients. This pilot study will assess the feasibility of an innovative telehealth evidence-based intervention for rural VA patients with chronic pain: the Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP). RAMP was developed with multiple-levels of VA stakeholders (including rural patients). It was designed to deliver multiple CIH self-management strategies (pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies) in one intervention, to overcome existing barriers to care and improve rural Veterans' pain and important biopsychosocial outcomes.
Interventions
BEHAVIORALRAMP program
The RAMP program is a 12-week virtual program consisting of an individual session (50 minutes) with a Whole Health Coach followed by 11 weekly interactive group sessions (90 minutes each) with pre-recorded expert led education videos, mind-body skill training and practice, and facilitated discussions.
Sponsors
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veteran participants must be rural dwelling * Patient's Veterans Affairs (VA) primary care provider is in the Southeast region of the US * Email address in the VA electronic health record (EHR) * Report pain at least most days in the past 3 months * Brief Pain Inventory (BPI) Pain Interference subscale score of 4 or greater * Willingness and ability to complete study activities including meeting remotely via videoconferencing when program sessions are held
Exclusion criteria
* Participation in a prior project conducted by the study team on mindfulness for pain (NCT0456158) or an engagement activities advisor for the current project * Current enrollment in a research study for pain * Current enrollment in a similar facilitated, multi-week, multi-modal CIH program * Severe, poorly controlled psychiatric or substance use disorder (based on chart review using structured checklists, conducted by trained staff who are trained and supervised by a clinical psychologist)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Recruited | 3 months | Number of participants recruited |
| Female Participants Recruited | 3 months | Percentage of Female Participants Recruited |
| Racial/Ethnic Minoritized Participants Recruited | 3 months | Percentage of Racial/Ethnic Minoritized Participants Recruited |
| Participant Satisfaction | 3 months | Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale |
| Participant Engagement | 3 months | Percentage of participants who participated in at least 7 out of 12 sessions either by attending the group session (i.e., synchronous participation) or reporting that they completed any of the session activities on their own (i.e., asynchronous participation) |
| Fidelity of Intervention Delivery | 3 months | Two experts in developing and delivering mind-body interventions for pain independently observed 10% of sessions via videoconference using a structured checklist. |
| Survey Response Rate | 3 month | Percentage of participants completing post-treatment data collection |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed