CAM in Veterans With Gulf War Illnesses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02180243

Acronym

GW-CAM

Enrollment

150

Registered

2014-07-02

Start date

2016-05-12

Completion date

2021-10-01

Last updated

2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gulf War Veterans' Illness

Keywords

meditation, acupuncture, Gulf War Veterans' Illness, Gulf War health education, iRest yoga

Brief summary

The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE) and iRest Yoga Nidra (mindfulness meditation)/auricular (ear) acupuncture for Veterans with Gulf War Veterans' Illnesses (GWVI).

Detailed description

Gulf War Veterans have reported irritable bowel syndrome, chronic fatigue, musculoskeletal pain, sleep difficulties, and neurocognitive dysfunction (for example, concentration, memory, and attention problems). The most effective treatment approach for what appears to a broad spectrum problem found in GWVI may require complementary alternative medicine (CAM) approaches to enhance positive outcomes. Mindfulness meditation and acupuncture are each broad spectrum CAM treatments designed to target multiple biological systems simultaneously, and thus may be well suited for GWVI. Gulf War Health Education group will promote wellness and prevention by utilizing a proactive patient care model.

Interventions

BEHAVIORALMindfulness meditation/Acupuncture

Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.

OTHERGulf War Health Education

Participants randomized to this group will take part in a health education group.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

RBANS assessment was blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* U.S. Veteran * Deployed to the Gulf War between 1990-1991 * Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment)

Exclusion criteria

* Addiction to drugs or alcohol * Experiences hallucinations or delusions * Currently manic * Currently suicidal * Hearing difficulties that would interfere with group participation * Current involvement in a meditation or acupuncture group

Design outcomes

Primary

Measure	Time frame	Description
Veterans RAND 36-item Health Survey - Mental Component Summary Scale	8 weeks	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.
Veterans RAND 36-Item Health Survey - Physical Component Summary Scale	8 weeks	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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Adult Short Form v1.0 - Pain Interference 8a	8 weeks	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.
Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a	8 weeks	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.

Secondary

Measure	Time frame	Description
Posttraumatic Symptom Checklist - Civilian Version (PCL-C)	8 weeks	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.
Short-form McGill Pain Questionnaire (SF-MPQ-2)	8 weeks	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.
The Brief Symptom Inventory (BSI)	8 weeks	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.
Perceived Stress Scale (PSS)	8 weeks	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.
Multidimensional Fatigue Symptom Inventory - Short Form (MFSI-SF)	8 weeks	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.
Quality of Life in Neurological Disorders (Neuro-QoL)	8 weeks	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.
Patient Health Questionnaire-Depression Module (PHQ-9)	8 weeks	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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
Mindfulness Meditation / Acupuncture 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.	74
Gulf War Health Education 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.	73
Total	147

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	12	2
Overall Study	Withdrawal by Subject	12	12

Baseline characteristics

Characteristic	Gulf War Health Education	Total	Mindfulness Meditation / Acupuncture
Age, Continuous	55.16 Years STANDARD_DEVIATION 7.52	54.31 Years STANDARD_DEVIATION 7.36	53.46 Years STANDARD_DEVIATION 7.15
Education	14.42 years STANDARD_DEVIATION 4.51	14.49 years STANDARD_DEVIATION 4.82	14.55 years STANDARD_DEVIATION 5.13
Employed	41 Participants	80 Participants	39 Participants
Married	44 Participants	91 Participants	47 Participants
Race/Ethnicity, Customized African American	53 Participants	102 Participants	49 Participants
Race/Ethnicity, Customized Other	7 Participants	15 Participants	8 Participants
Race/Ethnicity, Customized White	13 Participants	30 Participants	17 Participants
Sex: Female, Male Female	11 Participants	28 Participants	17 Participants
Sex: Female, Male Male	62 Participants	119 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 74	0 / 73
other Total, other adverse events	0 / 74	0 / 73
serious Total, serious adverse events	0 / 74	0 / 73

Outcome results

Primary

Patient-Reported Outcomes Measurement Information System Adult Short Form v1.0 - Fatigue 8a

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.

Time frame: 8 weeks