Trial Outcomes & Findings for CAM in Veterans With Gulf War Illnesses (NCT NCT02180243)

NCT ID: NCT02180243

Last Updated: 2023-09-01

Results Overview

The MCS is comprised of questions about role-emotional, vitality/mental health and social functioning. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2023-09-01

Participant Flow

Participants were recruited between May 2016 and September 2019 via flyers, internet postings with a link to the study recruitment webpage, referrals from primary care providers at the Washington, DC VAMC, and targeted outreach mailings to GW Veterans. Telephone or in-person interviews were conducted to determine eligibility.

Of 187 Veterans who began the consent process, 37 did not meet inclusion criteria and 1 enrolled but did not complete the randomization procedure. Therefore, 149 Veterans were randomized.

Participant milestones

Measure	Mindfulness Meditation / Acupuncture Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. Yoga/Acupuncture: Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.	Gulf War Health Education Eligible participants may be randomized to participate in Gulf War Health Education group classes. Gulf War Health Education: Participants randomized to this group will take part in a health education group.
Overall Study STARTED	75	74
Overall Study COMPLETED	51	60
Overall Study NOT COMPLETED	24	14

Reasons for withdrawal

Measure	Mindfulness Meditation / Acupuncture Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes. Yoga/Acupuncture: Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.	Gulf War Health Education Eligible participants may be randomized to participate in Gulf War Health Education group classes. Gulf War Health Education: Participants randomized to this group will take part in a health education group.
Overall Study Withdrawal by Subject	12	12
Overall Study Lost to Follow-up	12	2

Baseline Characteristics

CAM in Veterans With Gulf War Illnesses

Baseline characteristics by cohort

Measure	Mindfulness Meditation / Acupuncture n=74 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.	Total n=147 Participants Total of all reporting groups
Age, Continuous	53.46 Years STANDARD_DEVIATION 7.15 • n=5 Participants	55.16 Years STANDARD_DEVIATION 7.52 • n=7 Participants	54.31 Years STANDARD_DEVIATION 7.36 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	62 Participants n=7 Participants	119 Participants n=5 Participants
Race/Ethnicity, Customized African American	49 Participants n=5 Participants	53 Participants n=7 Participants	102 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Education	14.55 years STANDARD_DEVIATION 5.13 • n=5 Participants	14.42 years STANDARD_DEVIATION 4.51 • n=7 Participants	14.49 years STANDARD_DEVIATION 4.82 • n=5 Participants
Married	47 Participants n=5 Participants	44 Participants n=7 Participants	91 Participants n=5 Participants
Employed	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The MCS is comprised of questions about role-emotional, vitality/mental health and social functioning. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Veterans RAND 36-item Health Survey - Mental Component Summary Scale Endpoint	44.48 score on a scale Standard Deviation 8.09	40.62 score on a scale Standard Deviation 8.54
Veterans RAND 36-item Health Survey - Mental Component Summary Scale Baseline	42.26 score on a scale Standard Deviation 8.56	41.75 score on a scale Standard Deviation 8.46

PRIMARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. Scores are standardized using a t-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10 where higher scores indicate better health outcomes.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Veterans RAND 36-Item Health Survey - Physical Component Summary Scale Baseline	37.02 score on a scale Standard Deviation 8.78	37.00 score on a scale Standard Deviation 10.53
Veterans RAND 36-Item Health Survey - Physical Component Summary Scale Endpoint	39.41 score on a scale Standard Deviation 8.78	35.69 score on a scale Standard Deviation 10.99

PRIMARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

An eight-item self-reported pain instrument designed at the National Institutes of Health (NIH) to measure the extent to which pain interferes with involvement in cognitive, emotional, physical, recreational, and social activities. Higher scores represent greater symptom severity. Range from 0 - 32.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a Baseline	17.90 score on a scale Standard Deviation 8.96	17.47 score on a scale Standard Deviation 9.30
Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a Endpoint	14.55 score on a scale Standard Deviation 8.14	17.77 score on a scale Standard Deviation 9.66

PRIMARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

An 8-item NIH instrument consisting of eight items that asks about the experience and impact of fatigue. Higher scores represent greater symptom severity. Range from 0 - 32.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a Baseline	20.92 score on a scale Standard Deviation 8.26	20.74 score on a scale Standard Deviation 7.64
Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a Endpoint	17.69 score on a scale Standard Deviation 9.13	20.58 score on a scale Standard Deviation 8.65

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The SF-MPQ-2 measures continuous pain, intermittent pain, predominantly neuropathic pain, and affective descriptors. Higher scores indicate greater pain. Symptomatic pain on scale from 0 - 45.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Short-form McGill Pain Questionnaire (SF-MPQ-2) Baseline	16.88 score on a scale Standard Deviation 8.75	17.01 score on a scale Standard Deviation 9.58
Short-form McGill Pain Questionnaire (SF-MPQ-2) Endpoint	15.80 score on a scale Standard Deviation 9.46	19.42 score on a scale Standard Deviation 10.83

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The MFSI is a 30-item measurement tool that assesses the multidimensional nature of fatigue across five domains: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The range is from 24 to 96 with a higher score indicating higher levels of fatigue.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF) Baseline	37.40 score on a scale Standard Deviation 22.56	37.78 score on a scale Standard Deviation 23.57
Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF) Endpoint	27.69 score on a scale Standard Deviation 23.15	38.17 score on a scale Standard Deviation 27.59

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The items were selected from the 18 item Neuro-QOL Bank v1.0 - Applied Cognition - General Concerns. Scores range from 1 (very often) to 5 (none) for each cognitive symptom. Higher scores indicate better cognitive function. Range from 18 - 90.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Quality of Life in Neurological Disorders (Neuro-QoL) Baseline	48.85 score on a scale Standard Deviation 17.41	49.11 score on a scale Standard Deviation 17.77
Quality of Life in Neurological Disorders (Neuro-QoL) Endpoint	55.18 score on a scale Standard Deviation 18.39	48.65 score on a scale Standard Deviation 18.99

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The PHQ is a 9-item questionnaire, used to assess symptoms and functional impairment of depression to derive an overall severity score and a tentative depression diagnosis. Each item score ranges from 0-3 with higher scores indicating more severe depressive symptoms. Range from 0 - 27.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Patient Health Questionnaire-Depression Module (PHQ-9) Baseline	11.64 score on a scale Standard Deviation 6.42	12.29 score on a scale Standard Deviation 7.47
Patient Health Questionnaire-Depression Module (PHQ-9) Endpoint	9.76 score on a scale Standard Deviation 6.86	13.32 score on a scale Standard Deviation 8.44

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The PCL-C is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria with a range of 17-85. Higher scores indicate greater symptom expression.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Posttraumatic Symptom Checklist - Civilian Version (PCL-C) Baseline	31.95 score on a scale Standard Deviation 18.86	31.63 score on a scale Standard Deviation 22.04
Posttraumatic Symptom Checklist - Civilian Version (PCL-C) Endpoint	26.06 score on a scale Standard Deviation 18.84	34.71 score on a scale Standard Deviation 22.66

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The PSS is a 10-item scale that measures the degree to which situations in one's life over the past month are appraised as unpredictable, uncontrollable and overwhelming. Scores range from 0 to 40 with higher scores indicating higher perceived stress.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
Perceived Stress Scale (PSS) Baseline	18.68 score on a scale Standard Deviation 7.07	18.41 score on a scale Standard Deviation 8.44
Perceived Stress Scale (PSS) Endpoint	17.24 score on a scale Standard Deviation 6.81	19.17 score on a scale Standard Deviation 7.30

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants may have begun but not completed questionnaires assigned via mobile tablet resulting in differences in N for a given timepoint.

The Brief Symptom Inventory is a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Each subscale is averaged for all items, whereby a score of 4 would indicate the highest possible score.

Outcome measures

Measure	Mindfulness Meditation / Acupuncture n=73 Participants Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group. Mindfulness meditation /Acupuncture: Individuals randomized to this group will receive iRest Yoga Nidra and auricular acupuncture, administered one right after the other.	Gulf War Health Education n=73 Participants Eligible participants may be randomized to participate in Gulf War Health Education group. Gulf War Health Education: Participants randomized to this group will receive a weekly one-hour education session.
The Brief Symptom Inventory (BSI) Endpoint	0.97 score on a scale Standard Deviation 0.76	1.32 score on a scale Standard Deviation 0.99
The Brief Symptom Inventory (BSI) Baseline	1.12 score on a scale Standard Deviation 0.73	1.16 score on a scale Standard Deviation 0.86

Adverse Events

Mindfulness Meditation/Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gulf War Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew Reinhard, PsyD

War Related Illness and Injury Study Center

Phone: 202-745-8000

Email: matthew.reinhard@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place