Lyme Disease
Conditions
Keywords
yoga, telehealth, chronic pain
Brief summary
Primary Aims: Modify an existing teleyoga intervention to use with Lyme disease (LD) patients and address the technical challenges of at-home teleyoga
Detailed description
Participants with symptoms of Lyme disease (n=15) will participate individually in a weekly tele-yoga class using an iPad loaned by the study. Participants will choose where to attend these remote treatment sessions. Yoga treatment will last 12 weeks. Participants' subjective pain will be rated at baseline and end-of-treatment using a standard pain scale. Also assessed will be participant adherence to study protocol by tracking treatment attendance
Interventions
BEHAVIORALTeleyoga
12 weekly 75 minute therapist-led teleyoga sessions
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of probable Lyme disease * Has not begun new pain medications or other treatments in the last month * English literacy * Wireless internet connection at home
Exclusion criteria
* Participation in another concurrent clinical trial * Back surgery within the last 12 months * Unstable, coexisting mental illness or psychiatric condition * Active, current suicidal intent or plan * Attended or practiced yoga ≥ 1 x in the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain Score From Baseline | Measured at baseline and again at the end of 12 weeks of treatment | Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Treatment Protocol | at study completion, an average of 7 months | Percentage of participants who attend ≥65 percent of treatment sessions; values range from 0 percent to 100 percent with higher percentages indicative of a better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1:1 Sessions Yoga will be delivered in either a 1-on-1 format between the yoga therapist and the participant.
Participants will receive at-home teleyoga classes via video conferencing. | 5 |
| Group Sessions Yoga will be delivered in a group format between the yoga therapist and the participant.
Participants will receive at-home teleyoga classes via video conferencing. | 10 |
| Total | 15 |
Baseline characteristics
| Characteristic | 1:1 Sessions | Total | Group Sessions |
|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 14.3 | 41.3 years STANDARD_DEVIATION 13.5 | 43.5 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 11 Participants | 6 Participants |
| Region of Enrollment United States | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Female | 4 Participants | 12 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 10 |
| other Total, other adverse events | 0 / 5 | 0 / 10 |
| serious Total, serious adverse events | 0 / 5 | 0 / 10 |
Outcome results
Primary
Change of Pain Score From Baseline
Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes
Time frame: Measured at baseline and again at the end of 12 weeks of treatment
Population: 2 dyads dropped out
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1:1 Sessions | Change of Pain Score From Baseline | Average PEG Score at Baseline | 5.7 score on a scale |
| 1:1 Sessions | Change of Pain Score From Baseline | Average PEG score at end of treatment | 2.9 score on a scale |
| Group Sessions | Change of Pain Score From Baseline | Average PEG Score at Baseline | 4.8 score on a scale |
| Group Sessions | Change of Pain Score From Baseline | Average PEG score at end of treatment | 4.6 score on a scale |
Secondary
Adherence to the Treatment Protocol
Percentage of participants who attend ≥65 percent of treatment sessions; values range from 0 percent to 100 percent with higher percentages indicative of a better outcome
Time frame: at study completion, an average of 7 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1:1 Sessions | Adherence to the Treatment Protocol | 5 Participants |
| Group Sessions | Adherence to the Treatment Protocol | 7 Participants |