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Mindfulness-based Stress Reduction in Addition to Usual Care Is Associated with Improvements in Pain, Fatigue, and Cognitive Failures Among Veterans with Gulf War Illness
Center of Excellence in Substance Abuse Treatment and Education (CESATE), VA Puget Sound Health Care System, Seattle, WashDepartment of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle
Many Gulf War I veterans report ongoing negative health consequences. The constellation of pain, fatigue, and concentration/memory disturbances is referred to as “Gulf War illness.” Prior research suggests that mindfulness-based stress reduction may be beneficial for these symptoms, but mindfulness-based stress reduction has not been studied for veterans with Gulf War illness. The objective of this trial was to conduct a pilot study of mindfulness-based stress reduction for veterans with Gulf War illness.
Methods
Veterans (N = 55) with Gulf War illness were randomly assigned to treatment as usual plus mindfulness-based stress reduction or treatment as usual only. Mindfulness-based stress reduction was delivered in 8 weekly 2.5-hour sessions plus a single 7-hour weekend session. Pain, fatigue, and cognitive failures were the primary outcomes, assessed at baseline, after mindfulness-based stress reduction, and 6 months follow-up. Secondary outcomes included symptoms of posttraumatic stress disorder and depression.
Results
In intention-to-treat analyses, at 6-month follow-up, veterans randomized to mindfulness-based stress reduction plus treatment as usual reported greater reductions in pain (f = 0.33; P = .049), fatigue (f = 0.32; P = .027), and cognitive failures (f = 0.40; P < .001). Depressive symptoms showed a greater decline after mindfulness-based stress reduction (f = 0.22; P = .050) and at 6 months (f = 0.27; P = .031) relative to treatment as usual only. Veterans with posttraumatic stress disorder at baseline randomized to mindfulness-based stress reduction plus treatment as usual experienced significantly greater reductions in symptoms of posttraumatic stress disorder after mindfulness-based stress reduction (f = 0.44; P = .005) but not at 6 months follow-up (f = 0.31; P = .082).
Conclusions
Mindfulness-based stress reduction in addition to treatment as usual is associated with significant improvements in self-reported symptoms of Gulf War illness, including pain, fatigue, cognitive failures, and depression.
Attendance rates for Gulf War I veterans randomized to a mindfulness intervention (mindfulness-based stress reduction) were high.
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The addition of mindfulness-based stress reduction to usual care was associated with reductions in pain, fatigue, and cognitive failures compared with usual care alone at 6-month follow-up.
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Veterans with posttraumatic stress disorder at baseline randomized to mindfulness-based stress reduction in addition to usual care reported significant reductions in posttraumatic stress disorder symptoms immediately after mindfulness-based stress reduction and reductions at the level of a trend at 6-month follow-up.
Approximately 700,000 US military personnel were deployed to the Persian Gulf in 1990 and 1991. At least one fourth have reported negative health consequences,
Research Advisory Committee on Gulf War Veterans' Illnesses Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations.
including musculoskeletal pain, fatigue, and concentration/memory disturbances, the constellation of which is referred to as “Gulf War syndrome,” “Gulf War illness,” or “chronic multisymptom illness.”
Hunt SC. VA Approaches to the management of chronic multi-symptom illness in Gulf War I veterans. Presentation at the Third Committee Meeting, April 12, 2012, Irvine, California, 2012.
Research Advisory Committee on Gulf War Veterans' Illnesses Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations.
Research Advisory Committee on Gulf War Veterans' Illnesses Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations.
Centers for Disease Control and Prevention Unexplained illness among Persian Gulf War veterans in an air National Guard unit: preliminary report–August 1990-March 1995.
To date, one clinical trial for Gulf War illness has evaluated an integrative approach, which showed a modest benefit of cognitive behavioral therapy or exercise on symptoms of Gulf War illness, which declined over time.
Mindfulness has been defined as “the awareness that emerges by way of paying attention on purpose, in the present moment, and nonjudgmentally to the unfolding of experience moment by moment.”
Mindfulness-based interventions are intended to foster the ability to attend to thoughts, emotions, and bodily sensations with an attitude of curiosity, openness, acceptance, and love,
In mindfulness-based interventions, mindfulness skills are usually developed through a daily discipline of meditation and informal mindfulness practices. Evidence indicates that mindfulness-based interventions are associated with small to modest improvements in general symptom severity, pain, depression, and anxiety,
The effect of mindfulness training on mood and measures of fatigue, activity, and quality of life in patients with chronic fatigue syndrome on a hospital waiting list: a series of exploratory studies.
abilities, extant research on these types of interventions has not specifically assessed their effect on the memory and cognitive deficits commonly found among veterans with Gulf War illness.
This evidence raises the possibility that mindfulness-based interventions might be particularly well suited for symptom management of Gulf War illness. A widely available clinical method of teaching mindfulness is an 8-week class series called “mindfulness-based stress reduction.”
We conducted a pilot study to assess the impact of participation in mindfulness-based stress reduction as an adjunct to treatment as usual for veterans with Gulf War illness presenting as chronic multisymptom illness.
It was hypothesized that participation in mindfulness-based stress reduction would be associated with improvement in pain, fatigue, and cognitive impairments for veterans with Gulf War illness, relative to treatment as usual only. As a secondary aim, we sought to assess the influence of mindfulness-based stress reduction on symptoms of depression and posttraumatic stress disorder, which are common among previously deployed veterans.
Materials and Methods
The study was approved by the institutional review board at VA Puget Sound Health Care System and registered with clinicaltrials.gov NCT01267045.
Participants
Fifty-five participants were randomized to treatment as usual plus mindfulness-based stress reduction or treatment as usual only (Figure 1). Participants met criteria for Gulf War illness, defined as deployment to the Gulf War theater of operations between August 1990 and August 1991 and self-report of at least 2 of the following symptoms that began after August 1990, lasted at least 6 months, and were present at the time of the interview: (1) fatigue that limits usual activity; (2) musculoskeletal pain involving 2 or more regions of the body; and (3) cognitive symptoms (memory, concentration, or attention difficulties).
determined psychiatric exclusion criteria: (1) history of psychosis, (2) current mania, and (3) current suicidal or homicidal ideation. Additional exclusion criteria were prior participation in mindfulness-based stress reduction, active substance/alcohol abuse that posed a safety threat (current drinking and a past-year history of alcohol-related seizures or delirium tremens), or inpatient psychiatric admission within the past month.
Procedures
Recruitment sources included flyers in clinics and letters sent to Gulf War I veterans. Informed consent was obtained. After the baseline assessment, participants were stratified by baseline Patient Health Questionnaire-9 depression score ≥10 and randomly assigned (using concealed allocation) to treatment as usual plus mindfulness-based stress reduction or treatment as usual only. Measures were completed at baseline, 8 weeks later (the post–mindfulness-based stress reduction time point), and 6 months after the post–mindfulness-based stress reduction time point. The research assessor was blinded to the randomization arm. Participants continued to receive treatment as usual without intervention from the study team and received a small amount of monetary compensation for the research assessments. No compensation was provided to attend mindfulness-based stress reduction classes.
Clinical Assessment
Primary Outcomes
The following measures of pain, fatigue, and cognitive dysfunction were the primary outcomes: Pain was assessed by the Short-form McGill Pain Questionnaire,
a 25-item questionnaire that assesses proneness to commit cognitive errors in everyday tasks (Cronbach's α = 0.95).
Secondary Outcomes
Posttraumatic stress disorder symptoms were assessed using the Posttraumatic Stress Disorder Symptom Scale-Interview, a 17-item semistructured interview that assesses current posttraumatic stress disorder diagnostic status (Cronbach's α = 0.87).
(Cronbach's α = 0.86). In addition, the extensively validated National Institutes of Health Patient Reported Outcomes Measurement Information System measure for fatigue
was administered as an ancillary measure and is included here because of the suboptimal psychometric properties of the Multidimensional Fatigue Inventory general fatigue subscale found in our data. Mindfulness Skills were assessed using the Five Facet Mindfulness Questionnaire
King DW, King LA, Vogt DS, Knight J, Samper RE. Deployment risk and resilience inventory (DRRI): a collection of measures for studying deployment-related experiences of military personnel and veterans, Military Psychology, 18, 2006, 89–120.
A single experienced instructor led each mindfulness-based stress reduction group of 20 to 25 veterans; the courses were offered for clinical purposes. Within each mindfulness-based stress reduction group, 2 to 6 veterans were participants in the current study. Each mindfulness-based stress reduction class series met once per week (2.5 hours per session) for 8 weeks, plus a 7-hour session on a Saturday between weeks 6 and 7. Participants received instruction on mindfulness meditation practices, including body scan meditation, breathing meditation, gentle yoga, walking meditation, and loving-kindness meditation. The instructions for these practices were intended to foster increased awareness of thoughts, bodily sensations, and emotions, with an attitude of curiosity, openness, and acceptance. Throughout mindfulness-based stress reduction, participants were assigned to practice meditation led by audio CD for 30 to 45 minutes per day, 6 days per week. Homework also included informal mindfulness practices, such as bringing mindful attention to everyday activities such as walking or eating. Each participant was given a workbook and the book Full Catastrophe Living,
University of Massachusetts Medical Center/Worcester Stress Reduction Clinic. Full Catastrophe Living: Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness.
which outlined learning goals and homework assignments, and provided supplemental reading material.
Statistical Analyses
Patient characteristics are presented using descriptive statistics. Independent sample t tests and chi-square tests were used to evaluate baseline differences between treatment arms. Mean scores at baseline, post–mindfulness-based stress reduction, and 6-month follow-up were derived from linear mixed-effects models. Mixed-effects models account for within-subject correlation of responses over time and allow use of all available data across all time points to increase statistical efficiency. Randomization arm and time point were treated as fixed effects. Time × treatment interaction was assessed to determine whether subjects randomized to mindfulness-based stress reduction differed from those randomized to usual care with respect to change from baseline to post–mindfulness-based stress reduction and 6-month time points on outcomes; the significance level is presented for the time × treatment interaction. Between-group effect sizes were calculated using linear mixed-effects models as Cohen's f (0.10 small; 0.25 medium; 0.40 large). The primary analysis was conducted on an intention-to-treat basis. For secondary analyses, identical comparisons were conducted limiting the intervention group to those randomized to mindfulness-based stress reduction who attended ≥4 classes (“completer” analyses).
Additional secondary analyses were performed limiting the patient population to those who met symptom criteria for posttraumatic stress disorder at baseline.
All statistical analyses were performed using Stata (Release 11; StataCorp LP, College Station, Tex).
Results
The treatment groups did not differ significantly on demographic characteristics, trauma exposure, medication use, baseline prevalence of chronic conditions, disability status, scores on the primary or secondary outcome measures (Table 1), or deployment-related exposures (Table 2). Receipt of other treatments from baseline to 6-month follow-up also did not differ according to randomization arm (Table 1).
Table 1Baseline Characteristics of Participants
Characteristic
MBSR (n = 26)
Treatment as Usual (n = 29)
P Value
Age (y, mean ± SD)
51.3 ± 6.8
48.6 ± 7.4
.16
Women, n (%)
3 (11.5)
5 (17.2)
.55
Ethnicity, n (%)
.24
White
17 (72)
17 (58.6)
African American
2 (8.0)
8 (27.6)
Asian
1 (4)
2 (6.9)
Native American
0 (0.0)
1 (3.5)
Other
3 (12)
1 (3.5)
Married, n (%)
16 (61.5)
15 (51.7)
.52
McGill Pain Questionnaire scores
75.0 ± 32.5
81.2 ± 41.9
.55
Multidimensional Fatigue Inventory scores
General fatigue
16.0 ± 2.8
15.5 ± 3.2
.53
Physical fatigue
14.4 ± 2.7
15.3 ± 2.9
.28
Reduced activity
14.9 ± 4.1
14.3 ± 3.8
.63
Reduced motivation
11.5 ± 2.4
11.6 ± 2.4
.92
Mental fatigue
15.5 ± 3.6
15.6 ± 3.2
.97
Cognitive Failures Questionnaire
59.6 ± 16.5
58.3 ± 18.7
.78
PTSD Symptom Scale Interview
29.0 ± 11.2
26.2 ± 10.6
.35
Total No. of traumas
4.23 ± 2.8
4.72 ± 3.7
.58
Direct experience
2.76 ± 2.8
2.65 ± 2.2
.79
Learned about traumatic event
0.52 ± 1.1
0.30 ± .7
.88
Witnessed traumatic event
1.72 ± 1.6
1.65 ± 1.6
.40
Conditions listed in medical record at baseline, n (%)
Table 2Participant Exposure to Biological, Chemical, and Nuclear Agents
Characteristic
MBSR (n = 26) No. (%)
Treatment as Usual (n = 29) No. (%)
P Value
Pyridostigmine pills and vaccines
20 (77)
26 (90)
.33
Chemical and biological weapons
7 (27)
9 (31)
.81
Pesticides and insect repellent
18 (69)
22 (76)
.75
Smoke and diesel fume
22 (85)
28 (97)
.24
Depleted uranium
10 (38)
6 (21)
.13
Nonmilitary food
19 (73)
23 (79)
.78
Exploding artillery or missiles
14 (54)
20 (69)
.33
Entering enemy tank, bunker, or facility
12 (46)
17 (59)
.45
Values present the number and percentage of participants responding in the affirmative to items from VA Deployment Risk and Resiliency Inventory 2 Section F.
19 of 26 veterans (73%) randomized to mindfulness-based stress reduction were treatment completers. The mean number of mindfulness-based stress reduction class sessions attended was 5.7 (median number of sessions attended = 7; range, 0-9 sessions). Research compliance was high; 85% completed the post-test assessment; 82% completed the 6-month assessment.
Intention-To-Treat Analyses
Primary Outcomes
Table 3 and Figure 2 show the mean scores for outcome measures over time. Veterans randomized to mindfulness-based stress reduction did not report greater reductions in pain at immediate post-test but reported greater reductions at 6 months, with a medium to large effect size (f = 0.33; P = .049). Reductions in cognitive failures were greater for veterans randomized to mindfulness-based stress reduction at both immediate post-test and at 6 months with large effect sizes: f = 0.44 (P = .002) and f = 0.40 (P < .001), respectively. Those randomized to mindfulness-based stress reduction did not report greater reduction in fatigue (Multidimensional Fatigue Inventory) at immediate post-test but reported greater reductions in fatigue at 6 months with a medium to large effect size (f = 0.32; P = .027).
Table 3Mean Summary Scores and Cohen's f Effect Sizes* for Mindfulness-Based Stress Reduction (n = 26) vs Treatment as Usual (n = 29) for Intention-To-Treat and Completer Analyses
Summary Scores
Intention-To-Treat Analysis
Completer Analysis
Baseline Mean ± SD
Post-treatment Mean ± SD
6 Months Mean ± SD
Baseline Mean ± SD
Post-treatment Mean ± SD
6 Months Mean ± SD
Primary Outcomes
MPQ-2
MBSR
75.0 ± 32.5
54.0 ± 44.2
57.1 ± 44.7
69.6 ± 26.4
40.9 ± 23.9
46.6 ± 24.2
TAU
81.2 ± 41.9
65.5 ± 43.4
76.6 ± 49.3
81.2 ± 41.9
65.5 ± 43.4
76.6 ± 49.3
Effect size*
0.13
0.33
0.28
0.40
P value
.45
.05
.12
.01
MFI General Fatigue
MBSR
16.0 ± 2.8
14.9 ± 3.6
13.6 ± 3.4
16.3 ± 2.7
14.7 ± 3.2
13.6 ± 3.4
TAU
15.5 ± 3.2
15.5 ± 2.9
15.3 ± 3.6
15.5 ± 3.2
15.5 ± 2.9
15.3 ± 3.6
Effect size*
0.18
0.32
0.25
0.33
P value
.27
.03
.13
.02
CFQ
MBSR
59.6 ± 16.5
46.9 ± 18.1
46.6 ± 15.4
59.3 ± 16.1
58.3 ± 17.7
44.1 ± 14.8
TAU
58.3 ± 18.7
58.6 ± 18.1
61.9 ± 18.6
58.3 ± 18.7
58.6 ± 18.1
61.9 ± 18.6
Effect size*
0.44
0.40
0.64
0.49
P value
.002
<.001
<.001
<.001
Secondary Outcomes
PSS-I
MBSR
29.0 ± 11.2
20.7 ± 9.1
21.7 ± 10.8
28.3 ± 12.1
19.1 ± 9.1
20.4 ± 11.5
TAU
26.2 ± 10.6
24.7 ± 10.2
23.6 ± 10.7
26.2 ± 10.6
24.7 ± 10.2
23.6 ± 10.7
Effect size*
0.40
0.27
0.55
0.37
P value
.004
.08
.001
.02
PHQ-9
MBSR
14.4 ± 5.5
10.2 ± 6.2
9.5 ± 4.7
14.5 ± 5.4
9.2 ± 5.6
8.9 ± 4.8
TAU
12.8 ± 5.2
12.4 ± 6.7
12.3 ± 6.8
12.8 ± 5.2
12.4 ± 6.7
12.3 ± 6.8
Effect size*
0.22
0.27
0.31
0.38
P value
.05
.03
.01
.01
PROMIS fatigue
MBSR
62.2 ± 5.4
56.0 ± 8.6
57.5 ± 9.6
62.4 ± 5.0
55.3 ± 9.0
58.0 ± 10.0
TAU
62.1 ± 8.8
61.5 ± 9.3
62.0 ± 10.0
62.1 ± 8.8
61.5 ± 9.3
62.0 ± 10.0
Effect size*
0.35
0.26
0.43
0.23
P value
.02
.05
.008
.07
FFMQ
MBSR
115.8 ± 17.3
126.5 ± 22.7
129.4 ± 22.4
116.9 ± 18.0
129.7 ± 23.3
131.3 ± 20.9
TAU
115.1 ± 16.3
115.0 ± 15.1
114.6 ± 19.6
115.1 ± 16.3
115.0 ± 15.1
114.6 ± 19.6
Effect size*
0.28
0.38
0.30
0.48
P value
.046
.005
.03
.003
*Cohen's f 0 .10 small; 0.25 medium; 0.40 large.
Bolded values are statistically significant.
CFQ = Cognitive Failures Questionnaire; FFMQ = Five Facet Mindfulness Questionnaire; MBSR = mindfulness-based stress reduction; MFI = Multidimensional Fatigue Inventory; MPQ-2 = McGill Pain Questionnaire 2; PHQ-9 = Patient Health Questionnaire-9; PROMIS = Patient Reported Outcomes Measurement Information System; PSS-I = PTSD Symptom Score Interview; SD = standard deviation; TAU = treatment as usual.
Depressive symptoms showed a greater decline for those randomized to mindfulness-based stress reduction at immediate post-test and at 6 months with a medium effect size: f = 0.22 (P = .050) and f = 0.27 (P = .031), respectively. The National Institutes of Health Patient Reported Outcomes Measurement Information System fatigue measure showed greater reductions for veterans randomized to mindfulness-based stress reduction at both immediate post-test (f = 0.35; P = .015) and at 6 months (f = 0.26; P = .047) relative to treatment as usual only. Veterans randomized to mindfulness-based stress reduction demonstrated a greater increase in mindfulness skills, with a medium to large effect size at immediate post-test (f = 0.28; P = .046) and at 6 months (f = 0.38; P = .005) relative to treatment as usual only.
Because posttraumatic stress disorder is frequently comorbid with Gulf War illness,
For veterans with posttraumatic stress disorder at baseline who were randomized to mindfulness-based stress reduction plus treatment as usual, there were greater reductions in symptoms of posttraumatic stress disorder at the immediate post-test (with a large effect size, f = 0.44; P = .005), whereas at 6 months there was a trend toward greater reduction in posttraumatic stress disorder symptoms (f = 0.31; P = .082) compared with treatment as usual only.
Completer Analyses
Veterans randomized to mindfulness-based stress reduction who attended at least 4 classes (completers) were compared with veterans randomized to treatment as usual (Table 3). Analyses of primary outcome measures were similar to the intention-to-treat results. For secondary outcomes, mindfulness-based stress reduction completer results were similar to those of intention-to-treat analyses. For the National Institutes of Health Patient Reported Outcomes Measurement Information System fatigue measure, compared with usual care, mindfulness-based stress reduction completers reported greater reductions in fatigue at the post–mindfulness-based stress reduction time point (f = 0.43; P = .008), whereas at 6 months there was a trend toward significance (f = 0.23; P = .073).
Discussion
In this small trial, we found that veterans with Gulf War illness randomized to mindfulness-based stress reduction plus treatment as usual had significantly greater improvements, compared with treatment as usual alone, on the primary outcome measures of pain, fatigue, and cognitive failures when assessed 6 months after the intervention. We also found improvement in key secondary outcomes for those randomized to mindfulness-based stress reduction, including symptoms of posttraumatic stress disorder (among veterans who met diagnostic criteria for posttraumatic stress disorder at baseline), which improved at immediate post-test in intention-to-treat analyses but diminished somewhat at 6-month follow-up. At both follow-up time points, we found that veterans with Gulf War illness randomized to mindfulness-based stress reduction demonstrated increased mindfulness skills, with large effect sizes, suggesting that they learned the skills intended by the intervention. Overall, this study provides initial evidence to support offering mindfulness-based stress reduction as an intervention for Gulf War illness presenting as chronic multisymptom illness.
Outcomes of a mindfulness-based intervention have not been previously reported for Gulf War illness. However, our findings are consistent with studies of mindfulness-based interventions on symptoms that occur as a component of Gulf War illness.
The effect of mindfulness training on mood and measures of fatigue, activity, and quality of life in patients with chronic fatigue syndrome on a hospital waiting list: a series of exploratory studies.
Mindfulness-based cognitive therapy for people with chronic fatigue syndrome still experiencing excessive fatigue after cognitive behaviour therapy: a pilot randomized study.
The effect of mindfulness training on mood and measures of fatigue, activity, and quality of life in patients with chronic fatigue syndrome on a hospital waiting list: a series of exploratory studies.
Mindfulness-based cognitive therapy for people with chronic fatigue syndrome still experiencing excessive fatigue after cognitive behaviour therapy: a pilot randomized study.
It has been postulated that mindfulness allows uncoupling of the cognitive and emotional elements from the sensory experience of chronic pain, which could decrease distress or suffering.
An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results.
and interventions that reduce anxiety and reactivity could be especially helpful. Gulf War illness also can include changes in concentration and memory, and our study findings are consistent with a small prior literature that shows a negative correlation between measures of mindfulness and cognitive failures.
we found improvements in depressive symptoms. One possibility is that the observed changes in the self-reported primary outcomes could be mediated by the changes in depression or anxiety, but this initial study was not designed to test this hypothesis. Of note, our intention-to-treat analyses included 3 veterans randomized to mindfulness-based stress reduction who attended zero classes. Seventy-three percent of veterans randomized to mindfulness-based stress reduction attended at least 4 classes, which is similar to our prior experience with mindfulness-based stress reduction among veterans.
The apparent acceptability of mindfulness-based stress reduction is consistent with the larger body of literature that shows that veterans use complementary and alternative medicine at high rates.
The reduction in symptoms of posttraumatic stress disorder found in our study is generally consistent with prior studies of mindfulness-based interventions for posttraumatic stress disorder. Uncontrolled studies have shown improvement in posttraumatic stress disorder symptoms over time after mindfulness-based stress reduction,
A recent well-designed randomized controlled trial (N = 116) compared mindfulness-based stress reduction with an active control and found that those randomized to mindfulness-based stress reduction had greater improvement in posttraumatic stress disorder symptom severity, depression, and quality of life at 2-month follow-up.
However, a prior small randomized controlled trial (N = 47) compared mindfulness-based stress reduction with usual care for veterans with posttraumatic stress disorder and did not find a significant overall effect on symptoms of posttraumatic stress disorder, although a subset had clinically meaningful improvement in a post hoc analysis.
The findings of the current study provide additional evidence to indicate that participation in mindfulness-based stress reduction is associated with reductions in symptoms of posttraumatic stress disorder; this supports the need for additional, more definitive trials.
This study was not intended to address questions or propose theories regarding the cause or causes of Gulf War illness, but rather to focus on the suffering and health concerns currently experienced by this cohort of veterans. The perspective of the study was that serious health conditions such as Gulf War illness, regardless of original cause, involve symptoms and functional impairments that may be amenable to amelioration by learning and practicing mindfulness.
Study Limitations
This study has a number of limitations. This was designed as a pilot study; thus, we did not adjust for multiple comparisons, so that we would not miss potential associations that could lead to additional treatments for Gulf War illness.
Although the treatment as usual arm accounts for changes due to regression to the mean, it does not allow conclusions regarding whether changes occurred because of the mechanism conceptualized by the intervention vs nonspecific effects of group participation. An additional limitation is that we did not track change in medication use over the course of the study, such as opiates, which might influence study results. In addition, the reliability statistic for the Multidimensional Fatigue Inventory general fatigue subscale was suboptimal in our data, but we included a well-validated overlapping measure of fatigue (the National Institutes of Health Patient Reported Outcomes Measurement Information System fatigue measure), which showed improvement, supporting a significant effect of mindfulness-based stress reduction on fatigue.
Conclusions
The findings in this small trial provide initial support for offering mindfulness-based stress reduction to veterans with Gulf War illness and warrant larger randomized controlled trials of mindfulness-based stress reduction for Gulf War illness.
Acknowledgments
This material is based on work supported by the US Department of Veterans Affairs, Office of Research and Development, Clinical R&D Program.
References
Research Advisory Committee on Gulf War Veterans' Illnesses
Gulf War Illness and the Health of Gulf War Veterans: Scientific Findings and Recommendations.
Hunt SC. VA Approaches to the management of chronic multi-symptom illness in Gulf War I veterans. Presentation at the Third Committee Meeting, April 12, 2012, Irvine, California, 2012.
The effect of mindfulness training on mood and measures of fatigue, activity, and quality of life in patients with chronic fatigue syndrome on a hospital waiting list: a series of exploratory studies.
King DW, King LA, Vogt DS, Knight J, Samper RE. Deployment risk and resilience inventory (DRRI): a collection of measures for studying deployment-related experiences of military personnel and veterans, Military Psychology, 18, 2006, 89–120.
Mindfulness-based cognitive therapy for people with chronic fatigue syndrome still experiencing excessive fatigue after cognitive behaviour therapy: a pilot randomized study.
An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results.