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SDR 15-197 – HSR&D Study

SDR 15-197
Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
Tracy L Simpson PhD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, WA
Funding Period: April 2017 - January 2022

Nearly 700,000 US military personnel were deployed to the Persian Gulf in 1990-1991. At least one fourth report negative health consequences including pain, fatigue, and concentration/mood disturbances, known as Chronic Multisymptom Illness (CMI). Although several studies have examined causes of CMI among Gulf War (GW) Veterans, studies of treatment remain limited. Current CMI management includes an integrative approach informed by the biopsychosocial model, with self-management components. Mindfulness-based interventions (MBIs) teach meditation practices intended to enhance present moment awareness and emphasize continued practices after program completion. A widely available mindfulness program is an 8-week program called Mindfulness-Based Stress Reduction (MBSR). Preliminary evidence suggests that MBIs reduce symptoms of CMI. Another widely available self-management program is the Chronic Disease Self-Management Program (CSMP).

Aim 1: Among GW Veterans with CMI, evaluate if MBSR produces greater improvement than CDSMP in symptoms of CMI (pain, fatigue, cognitive failures) at 6-months post-treatment. Aim 2: Assess patient satisfaction and acceptability of either treatment using a mixed methods approach involving a) qualitative semi-structured interviews of GW Veterans and b). a measure of patient satisfaction.Exploratory Aims: Evaluate if MBSR is produces greater improvement than CDSMP in symptoms of CMI among non-GW Veterans, as well as other domains of health for both GW Veterans and non-GW Veterans with CMI. Other domains assessed will be depressive symptoms, PTSD symptoms, substance use, and Health-Related Quality of Life (HRQOL). Additional analyses will explore baseline moderators of response.

A randomized controlled trial comparing MBSR to CDSMP. Participants: At least 154 GW Veterans with CMI, and up to 154 non-GW Veterans with CMI. Interventions: Group MBSR or an augmented 8-week version of CDSMP. Hypotheses and Analyses: GW Veterans randomized to MBSR will report significantly greater reductions in pain, fatigue and cognitive failures at 6-month follow-up as compared to CDSMP, and will be more satisfied with care.

Aim 1 (Primary outcomes for GW participants): Eighty-seven GW Veterans were randomized to receive either MBSR (n = 44) or CDSMP (n = 43). Participants were assessed at baseline, immediate post-treatment, and 3- and 6-months post-treatment on the following indicators of chronic multi-system illness: pain (McGill Pain Questionnaire); fatigue (MDFI General Fatigue measure), and cognitive failures (Cognitive Failures Questionnaire). Intent-to-treat multilevel mixed effects models with random effects for repeated measures were used to compare the two groups on these three primary outcomes. At no timepoint did we find a significant between-group difference on any of these outcomes, including at our primary endpoint of 6-months, at which time the p values ranged from 0.55 to 0.99.
Of note, in addition to the lack of between-group differences on the primary outcomes among the GW participants, we did not see appreciable improvements over time for participants in either condition on any of these outcomes.
Aim 2 (Mixed methods acceptability and satisfaction among GW participants):
Quantitative Findings: The Client Satisfaction Questionnaire (CSQ-8) was used to assess Veteran treatment satisfaction in this study. Among Gulf War Veterans, a larger proportion of those assigned to MBSR were very or completely satisfied with the treatment (87%) than those assigned to CDSMP (71%). This difference did not, however, reach statistical significance.
Treatment completion was defined as having attended at least 4 of the 8 sessions; 70% of those assigned to CDSMP and 55% of those assigned to MBSR met this attendance threshold, a difference that was not statistically significant (p = 0.143).
Qualitative Findings: Sixty-four qualitative interviews were conducted with Gulf War Veterans; 29 assigned to CDSMP and 35 assigned to MBSR. Veterans who did not complete treatment were also interviewed and invited to speak to the groups' acceptability; 5 non-completers were interviewed for CDSMP and 13 non-completers were interviewed for MBSR. Details regarding the qualitative acceptability findings are presented below by condition.
CDSMP: Veterans in CDSMP reported that they enjoyed participating in the groups with other Veterans. They also appreciated the content, including making and being held accountable to action plans, and they found it valuable that instructors shared their personal experiences with pain and fatigue. Veterans who were naïve to health education found the content about nutrition and navigating pain satisfactory. Veterans who were experienced in these areas generally reported satisfaction with these lessons as well, but noted that they did not feel that they learned anything new and that their satisfaction was in being able to teach and support other Veterans. A few Veterans in this group who were highly experienced in pain and health management found the content of CDSMP to be too simple and beginner level; these Veterans reported low acceptability of CDSMP.
MBSR: Veterans in MBSR reported they felt relaxed and calm when doing MBSR exercises. Many Veterans in this treatment condition shared that the group made them feel like they were not alone. Many also reported that MBSR taught them about themselves and their relationships, and that they used those skills in their lives. The few Veterans who did not find MBSR acceptable reported that they felt MBSR went against their religious values, that it was too emotional and felt like a support group, and that MBSR was condescending in that being told to have a beginner's mind was being talked down to for their experience and age.
A few Veterans in both CDSMP and MBSR said that the groups were not acceptable to them because of the nature of groups generally, and they emphasized their lack of interest in participating group-based patient education.
Exploratory Aim: The same pattern of non-significant between-group differences on the primary outcomes was found for the non-GW Veterans included in the study (MBSR: n = 67; CDSMP: n = 64) except that there was a significant between-group difference favoring the MBSR group at the immediate post-test regarding cognitive failures (p = 0.020). Treatment completion among the non-GW participants did not differ by treatment assignment; 68% of Veterans assigned to MBSR or to CDSMP attended four or more sessions.
When the GW and non-GW Veterans were combined, there were no significant between-group differences on the primary outcomes at any timepoint nor on treatment completion (MBSR: 62.61%; CDSMP: 68.42%, ns).

Contrary to expectation, we did not find that Gulf War Veterans randomized to receive MBSR had better outcomes on pain, fatigue, or cognitive failures than Gulf War Veterans randomized to receive CDSMP. Moreover, although Gulf War Veterans generally reported finding both interventions acceptable via quantitative and qualitative assessments, we found little to suggest that that either intervention was associated with much improvement over time. This same pattern of results was apparent for the non-Gulf War Veteran study participants with chronic multi-system illness - solid acceptability and treatment satisfaction but neither significant between group differences nor appreciable within-subject improvements over time. We also found that among the Gulf War participants, our target intervention, MBSR, was associated with lower treatment completion than was CDSMP. Thus, although it is possible that MBSR would be helpful to some Gulf War Veterans, study results suggest that it is not an intervention that should be widely disseminated or recommended for this population of Veterans. Similarly, although some non-Gulf War Veterans with chronic multi-system illness may find MBSR helpful, the current study provides no support for including it in the primary treatment options made available to these Veterans. For both groups of Veterans, CDSMP had similarly disappointing results and thus is not a recommended alternative treatment option.

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NIH Reporter

Grant Number: I01HX001828-01A1

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None at this time.

DRA: Military and Environmental Exposures, Other Conditions
DRE: TRL - Applied/Translational
Keywords: none
MeSH Terms: none

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