Trial Outcomes & Findings for Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health (NCT NCT05097521)
NCT ID: NCT05097521
Last Updated: 2026-05-04
Results Overview
Measure of pain severity. Scores range from 0-10, with higher scores indicating more severe pain.
COMPLETED
3603 participants
Change from baseline to 6 months
2026-05-04
Participant Flow
Participant milestones
| Measure |
Veterans Using Practitioner-delivered CIH Therapies Only
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
Veterans Using Self-care CIH Therapies Only
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings
|
|---|---|---|---|
|
Overall Study
STARTED
|
1688
|
1618
|
297
|
|
Overall Study
COMPLETED
|
1688
|
1618
|
297
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health
Baseline characteristics by cohort
| Measure |
Veterans Using Practitioner-delivered CIH Therapies Only
n=1688 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1618 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
Veterans Using Self-care CIH Therapies Only
n=297 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Total
n=3603 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 Years
STANDARD_DEVIATION 14 • n=54 Participants
|
54 Years
STANDARD_DEVIATION 13 • n=60 Participants
|
57 Years
STANDARD_DEVIATION 13 • n=114 Participants
|
57 Years
STANDARD_DEVIATION 14 • n=1 Participants
|
|
Sex: Female, Male
Female
|
227 Participants
n=54 Participants
|
438 Participants
n=60 Participants
|
78 Participants
n=114 Participants
|
743 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1461 Participants
n=54 Participants
|
1180 Participants
n=60 Participants
|
219 Participants
n=114 Participants
|
2860 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
163 Participants
n=54 Participants
|
172 Participants
n=60 Participants
|
26 Participants
n=114 Participants
|
361 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1451 Participants
n=54 Participants
|
1357 Participants
n=60 Participants
|
259 Participants
n=114 Participants
|
3067 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
74 Participants
n=54 Participants
|
89 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
175 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=54 Participants
|
19 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
34 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=54 Participants
|
25 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
50 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
17 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
39 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
266 Participants
n=54 Participants
|
347 Participants
n=60 Participants
|
87 Participants
n=114 Participants
|
700 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
1241 Participants
n=54 Participants
|
1068 Participants
n=60 Participants
|
193 Participants
n=114 Participants
|
2502 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
37 Participants
n=54 Participants
|
20 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
60 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
89 Participants
n=54 Participants
|
121 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
218 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
1688 Participants
n=54 Participants
|
1618 Participants
n=60 Participants
|
297 Participants
n=114 Participants
|
3603 Participants
n=1 Participants
|
|
Smoking Status
Current smoker
|
402 Participants
n=54 Participants
|
355 Participants
n=60 Participants
|
82 Participants
n=114 Participants
|
839 Participants
n=1 Participants
|
|
Smoking Status
Former smoker
|
652 Participants
n=54 Participants
|
525 Participants
n=60 Participants
|
97 Participants
n=114 Participants
|
1274 Participants
n=1 Participants
|
|
Smoking Status
Never smoker
|
632 Participants
n=54 Participants
|
731 Participants
n=60 Participants
|
117 Participants
n=114 Participants
|
1480 Participants
n=1 Participants
|
|
Smoking Status
Unknown
|
10 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
18 Participants
n=1 Participants
|
|
Elixhauser Comorbidity Index
|
5.1 units on a scale
STANDARD_DEVIATION 3.1 • n=54 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 3.0 • n=60 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 3.3 • n=114 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 3.1 • n=1 Participants
|
|
Pain Type
Back Pain
|
1266 Participants
n=54 Participants
|
1188 Participants
n=60 Participants
|
188 Participants
n=114 Participants
|
2642 Participants
n=1 Participants
|
|
Pain Type
Joint Pain
|
1310 Participants
n=54 Participants
|
1254 Participants
n=60 Participants
|
234 Participants
n=114 Participants
|
2798 Participants
n=1 Participants
|
|
Pain Type
Neck Pain
|
667 Participants
n=54 Participants
|
641 Participants
n=60 Participants
|
96 Participants
n=114 Participants
|
1404 Participants
n=1 Participants
|
|
Pain Type
Musculoskeletal Chest Pain
|
200 Participants
n=54 Participants
|
201 Participants
n=60 Participants
|
42 Participants
n=114 Participants
|
443 Participants
n=1 Participants
|
|
Pain Type
Fibromyalgia
|
56 Participants
n=54 Participants
|
100 Participants
n=60 Participants
|
19 Participants
n=114 Participants
|
175 Participants
n=1 Participants
|
|
Pain Type
Other Pain
|
483 Participants
n=54 Participants
|
596 Participants
n=60 Participants
|
123 Participants
n=114 Participants
|
1202 Participants
n=1 Participants
|
|
Opioid Use during Prior 90 Days
None
|
1239 Participants
n=54 Participants
|
1203 Participants
n=60 Participants
|
206 Participants
n=114 Participants
|
2648 Participants
n=1 Participants
|
|
Opioid Use during Prior 90 Days
Ongoing Opioid Prescription
|
202 Participants
n=54 Participants
|
168 Participants
n=60 Participants
|
47 Participants
n=114 Participants
|
417 Participants
n=1 Participants
|
|
Opioid Use during Prior 90 Days
New Opioid Prescription
|
67 Participants
n=54 Participants
|
61 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
139 Participants
n=1 Participants
|
|
Opioid Use during Prior 90 Days
Recently Quit
|
180 Participants
n=54 Participants
|
186 Participants
n=60 Participants
|
33 Participants
n=114 Participants
|
399 Participants
n=1 Participants
|
|
Pain Clinic Visit in Past 30 Days
|
219 Participants
n=54 Participants
|
227 Participants
n=60 Participants
|
48 Participants
n=114 Participants
|
494 Participants
n=1 Participants
|
|
Physical Therapy Use in Past 30 Days
|
278 Participants
n=54 Participants
|
318 Participants
n=60 Participants
|
45 Participants
n=114 Participants
|
641 Participants
n=1 Participants
|
|
Whole Health Use in Past 30 Days
|
227 Participants
n=54 Participants
|
391 Participants
n=60 Participants
|
145 Participants
n=114 Participants
|
763 Participants
n=1 Participants
|
|
Mental Health Conditions
Anxiety
|
710 Participants
n=54 Participants
|
964 Participants
n=60 Participants
|
173 Participants
n=114 Participants
|
1847 Participants
n=1 Participants
|
|
Mental Health Conditions
Depression
|
801 Participants
n=54 Participants
|
1001 Participants
n=60 Participants
|
220 Participants
n=114 Participants
|
2022 Participants
n=1 Participants
|
|
Mental Health Conditions
PTSD
|
700 Participants
n=54 Participants
|
901 Participants
n=60 Participants
|
179 Participants
n=114 Participants
|
1780 Participants
n=1 Participants
|
|
Mental Health Service in Past 30 Days
|
327 Participants
n=54 Participants
|
535 Participants
n=60 Participants
|
134 Participants
n=114 Participants
|
996 Participants
n=1 Participants
|
|
Service-Connected Percentage
Less than 50%
|
541 Participants
n=54 Participants
|
419 Participants
n=60 Participants
|
67 Participants
n=114 Participants
|
1027 Participants
n=1 Participants
|
|
Service-Connected Percentage
50% or more
|
1147 Participants
n=54 Participants
|
1199 Participants
n=60 Participants
|
230 Participants
n=114 Participants
|
2576 Participants
n=1 Participants
|
|
Distance to Nearest Primary Care Site
2 miles or less
|
114 Participants
n=54 Participants
|
124 Participants
n=60 Participants
|
23 Participants
n=114 Participants
|
261 Participants
n=1 Participants
|
|
Distance to Nearest Primary Care Site
2 to 15 miles
|
952 Participants
n=54 Participants
|
931 Participants
n=60 Participants
|
175 Participants
n=114 Participants
|
2058 Participants
n=1 Participants
|
|
Distance to Nearest Primary Care Site
Greater than 15 miles
|
527 Participants
n=54 Participants
|
443 Participants
n=60 Participants
|
78 Participants
n=114 Participants
|
1048 Participants
n=1 Participants
|
|
Distance to Nearest Primary Care Site
Unknown
|
95 Participants
n=54 Participants
|
120 Participants
n=60 Participants
|
21 Participants
n=114 Participants
|
236 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Measure of pain severity. Scores range from 0-10, with higher scores indicating more severe pain.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=297 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=952 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1426 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI) Severity Scale
Baseline
|
6.3 units on a scale
Standard Deviation 1.7
|
5.9 units on a scale
Standard Deviation 1.7
|
6.0 units on a scale
Standard Deviation 1.7
|
|
Brief Pain Inventory (BPI) Severity Scale
Six-Month Follow-Up
|
5.9 units on a scale
Standard Deviation 1.7
|
5.3 units on a scale
Standard Deviation 1.9
|
5.4 units on a scale
Standard Deviation 1.8
|
|
Brief Pain Inventory (BPI) Severity Scale
Difference
|
-0.3 units on a scale
Standard Deviation 1.6
|
-0.6 units on a scale
Standard Deviation 1.6
|
-0.5 units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Measure of pain-related functional interference. Scores range from 0-10, with higher scores indicating greater pain-related functional interference.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=230 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=947 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1426 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Brief Pain Inventory (BPI) Interference Scale
Baseline
|
6.8 units on a scale
Standard Deviation 2.1
|
6.3 units on a scale
Standard Deviation 2.2
|
6.6 units on a scale
Standard Deviation 2.2
|
|
Brief Pain Inventory (BPI) Interference Scale
Six-Month Follow-Up
|
6.4 units on a scale
Standard Deviation 2.3
|
5.7 units on a scale
Standard Deviation 2.4
|
5.9 units on a scale
Standard Deviation 2.4
|
|
Brief Pain Inventory (BPI) Interference Scale
Difference
|
-0.5 units on a scale
Standard Deviation 2.0
|
-0.6 units on a scale
Standard Deviation 2.0
|
-0.7 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Single-item scale which assesses how much a patient perceives their pain has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse pain outcomes following the specified intervention.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=297 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1688 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1618 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC) for Improvement in Pain
'Much Better' or 'Slightly Better' pain
|
104 Participants
|
821 Participants
|
868 Participants
|
|
Patient Global Impression of Change (PGIC) for Improvement in Pain
'Neutral', 'Slightly Worse', or 'Much Worse' pain
|
193 Participants
|
867 Participants
|
750 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Single-item scale which assesses how much a patient perceives their mental health has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse mental health outcomes following the specified intervention.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=297 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1681 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1611 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC) for Improvement in Mental Health
'Neutral', 'Slightly Worse', or 'Much Worse' mental health
|
182 Participants
|
1203 Participants
|
909 Participants
|
|
Patient Global Impression of Change (PGIC) for Improvement in Mental Health
'Much Better' or 'Slightly Better' mental health
|
115 Participants
|
478 Participants
|
702 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Single-item scale which assesses how much a patient perceives their fatigue has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse fatigue outcomes following the specified intervention.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=297 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1678 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1607 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC) for Improvement in Fatigue
'Much Better' or 'Slightly Better' fatigue
|
89 Participants
|
441 Participants
|
556 Participants
|
|
Patient Global Impression of Change (PGIC) for Improvement in Fatigue
'Neutral', 'Slightly Worse', or 'Much Worse' fatigue
|
208 Participants
|
1237 Participants
|
1051 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Single-item scale which assesses how much a patient perceives their overall well-being has improved following a specified intervention. Item rated on a 5-point scale ranging from 1 to 5, with 1 being "much better" and 5 being "much worse". Higher scores represent worse overall well-being outcomes following the specified intervention.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=297 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1676 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1605 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Patient Global Impression of Change (PGIC) for Improvement in Overall Well-being
'Much Better' or 'Slightly Better' overall well-being
|
125 Participants
|
665 Participants
|
844 Participants
|
|
Patient Global Impression of Change (PGIC) for Improvement in Overall Well-being
'Neutral', 'Slightly Worse', or 'Much Worse' overall well-being
|
172 Participants
|
1011 Participants
|
761 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Assesses physical function, fatigue, pain, and social health; score derived from the PROMIS10 Global Health measure which assesses physical and mental health and generates two summary scores: Global Physical Health and Global Mental Health. Scores are reported on a T-score metric wherein the mean score of the general population is standardized to 50 with a standard deviation of 10. A score of 50 indicates average physical health, as compared to the general population. Higher scores indicate better physical health.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=229 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=937 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1409 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
PROMIS10 Global Assessment of Physical Health
Baseline
|
35.0 T-Score
Standard Deviation 5.7
|
37.4 T-Score
Standard Deviation 6.0
|
36.8 T-Score
Standard Deviation 6.3
|
|
PROMIS10 Global Assessment of Physical Health
Six-Month Follow-Up
|
35.7 T-Score
Standard Deviation 6.2
|
38.3 T-Score
Standard Deviation 6.2
|
37.9 T-Score
Standard Deviation 6.6
|
|
PROMIS10 Global Assessment of Physical Health
Difference
|
0.7 T-Score
Standard Deviation 5.5
|
0.9 T-Score
Standard Deviation 5.0
|
1.1 T-Score
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Assesses emotional distress and mental health; score derived from the PROMIS10 Global Health measure which assesses physical and mental health and generates two summary scores: Global Physical Health and Global Mental Health. Scores are reported on a T-score metric wherein the mean score of the general population is standardized to 50 with a standard deviation of 10. A score of 50 indicates average mental health, as compared to the general population. Higher scores indicate better mental health.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=292 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1629 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1569 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
PROMIS10 Global Assessment of Mental Health
Baseline
|
37.3 T-Score
Standard Deviation 8.7
|
41.0 T-Score
Standard Deviation 9.2
|
38.9 T-Score
Standard Deviation 8.8
|
|
PROMIS10 Global Assessment of Mental Health
Six-Month Follow-Up
|
38.2 T-Score
Standard Deviation 8.9
|
41.5 T-Score
Standard Deviation 9.4
|
39.7 T-Score
Standard Deviation 8.8
|
|
PROMIS10 Global Assessment of Mental Health
Difference
|
1.0 T-Score
Standard Deviation 6.4
|
0.5 T-Score
Standard Deviation 6.5
|
0.9 T-Score
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
6 items are rated on a 5-point Likert scale ranging from 1 to 5. Scores range from 6 to 30, with higher scores indicating better life engagement/purpose in life.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=294 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1623 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1555 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Life Engagement Test (LET)
Baseline
|
21.4 units on a scale
Standard Deviation 5.0
|
23.2 units on a scale
Standard Deviation 4.9
|
22.6 units on a scale
Standard Deviation 5.1
|
|
Life Engagement Test (LET)
Six-Month Follow-Up
|
21.7 units on a scale
Standard Deviation 5.4
|
23.2 units on a scale
Standard Deviation 4.9
|
22.7 units on a scale
Standard Deviation 5.2
|
|
Life Engagement Test (LET)
Difference
|
0.2 units on a scale
Standard Deviation 4.0
|
0.0 units on a scale
Standard Deviation 3.7
|
0.1 units on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Measure of perceived stress consisting of 4 items which are each rated on a 5-point scale ranging from 0 to 4. Scores range from 0 to 16, with higher scores indicating greater perceived stress.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=290 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1630 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1552 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Perceived Stress Scale (PSS-4)
Six-Month Follow-Up
|
7.1 units on a scale
Standard Deviation 3.5
|
5.7 units on a scale
Standard Deviation 3.5
|
6.4 units on a scale
Standard Deviation 3.4
|
|
Perceived Stress Scale (PSS-4)
Difference
|
-0.4 units on a scale
Standard Deviation 3.1
|
-0.3 units on a scale
Standard Deviation 3.0
|
-0.4 units on a scale
Standard Deviation 2.9
|
|
Perceived Stress Scale (PSS-4)
Baseline
|
7.5 units on a scale
Standard Deviation 3.6
|
5.9 units on a scale
Standard Deviation 3.5
|
6.8 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Measure of depressed mood and anhedonia consisting of 2 items which are each rated on a 7-point scale ranging from 0 to 6. Scores range from 0 to 12, with higher scores indicating more depressive symptoms.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=294 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1630 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1563 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Patient Health Questionnaire (PHQ2)
Baseline
|
3.0 units on a scale
Standard Deviation 2.0
|
2.3 units on a scale
Standard Deviation 1.9
|
2.6 units on a scale
Standard Deviation 1.9
|
|
Patient Health Questionnaire (PHQ2)
Six-Month Follow-Up
|
2.7 units on a scale
Standard Deviation 1.9
|
2.1 units on a scale
Standard Deviation 1.9
|
2.4 units on a scale
Standard Deviation 1.9
|
|
Patient Health Questionnaire (PHQ2)
Difference
|
-0.3 units on a scale
Standard Deviation 1.6
|
-0.3 units on a scale
Standard Deviation 1.6
|
-0.2 units on a scale
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
2-item measure of perceived health competency with each item rated on a 5-point scale from 1 to 5. Scores range from 2 to 10, with higher scores indicating greater perceived health competency.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=294 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1630 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1565 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Perceived Health Competency Scale (PHCS-2)
Baseline
|
2.7 units on a scale
Standard Deviation 1.2
|
3.0 units on a scale
Standard Deviation 1.2
|
2.8 units on a scale
Standard Deviation 1.2
|
|
Perceived Health Competency Scale (PHCS-2)
Six-Month Follow-Up
|
2.9 units on a scale
Standard Deviation 1.2
|
3.0 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.2
|
|
Perceived Health Competency Scale (PHCS-2)
Difference
|
0.1 units on a scale
Standard Deviation 1.2
|
0.0 units on a scale
Standard Deviation 1.3
|
0.1 units on a scale
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Altarum Consumer Engagement/Ownership Subscale measures perceived role in and responsibility for one's health. Scores range from 5-25, with higher scores indicating greater responsibility and ownership.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=294 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1622 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1556 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Altarum Consumer Engagement (ACE)
Six-Month Follow-Up
|
7.4 units on a scale
Standard Deviation 4.0
|
6.7 units on a scale
Standard Deviation 4.0
|
6.4 units on a scale
Standard Deviation 3.9
|
|
Altarum Consumer Engagement (ACE)
Difference
|
0.4 units on a scale
Standard Deviation 3.8
|
-0.1 units on a scale
Standard Deviation 3.7
|
0.0 units on a scale
Standard Deviation 3.6
|
|
Altarum Consumer Engagement (ACE)
Baseline
|
7.0 units on a scale
Standard Deviation 3.8
|
6.8 units on a scale
Standard Deviation 3.9
|
6.4 units on a scale
Standard Deviation 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 6 monthsPopulation: Results are reported for participants who had measurable scores in both the baseline and six-month survey for this measure. Statistical analyses were not performed for the "Veterans Using Self-care CIH Therapies Only" group as the sample size did not meet the minimum threshold necessary to detect between-group differences of interest, as detailed in the Study Protocol.
Items 5 and 6 from the 6-item Self-Efficacy for Managing Chronic Disease (SEMCD) scale with each item rated on a scale of 1 to 10. Scored as the 2-item mean, with higher scores indicating greater self-efficacy.
Outcome measures
| Measure |
Veterans Using Self-care CIH Therapies Only
n=293 Participants
Veterans using self-care (yoga, meditation, Tai Chi, Qi Gong) CIH therapies only, as received in VHA and community practice settings.
|
Veterans Using Practitioner-delivered CIH Therapies Only
n=1613 Participants
Veterans using practitioner-delivered CIH therapies (acupuncture, therapeutic massage, chiropractic care) only, as received in VHA and community practice settings.
|
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
n=1549 Participants
Veterans using a combination of practitioner-delivered (chiropractic care, acupuncture, therapeutic massage) and self-care (Tai Chi/Qigong, yoga, meditation) CIH therapies (dual-care) as received in VHA and community practice settings.
|
|---|---|---|---|
|
Self-Efficacy for Managing Chronic Disease (SEMCD)
Baseline
|
6.0 units on a scale
Standard Deviation 2.2
|
6.3 units on a scale
Standard Deviation 2.2
|
6.5 units on a scale
Standard Deviation 2.2
|
|
Self-Efficacy for Managing Chronic Disease (SEMCD)
Six-Month Follow-Up
|
6.0 units on a scale
Standard Deviation 2.2
|
6.3 units on a scale
Standard Deviation 2.2
|
6.5 units on a scale
Standard Deviation 2.2
|
|
Self-Efficacy for Managing Chronic Disease (SEMCD)
Difference
|
0.0 units on a scale
Standard Deviation 2.1
|
0.0 units on a scale
Standard Deviation 2.2
|
0.1 units on a scale
Standard Deviation 2.2
|
Adverse Events
Veterans Using Practitioner-delivered CIH Therapies Only
Veterans Using a Combination of Practitioner-delivered and Self-care CIH Therapies (Dual-care)
Veterans Using Self-care CIH Therapies Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stephanie L. Taylor
VA Greater Los Angeles Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place