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Mindfulness-Based Stress Reduction for Gulf War Syndrome

A Randomized Controlled Trial of a Mindfulness Based Intervention for Gulf War Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01267045
Enrollment
55
Registered
2010-12-24
Start date
2010-10-31
Completion date
2014-04-30
Last updated
2015-08-07

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

Conditions

Persian Gulf Syndrome

Keywords

Persian Gulf Syndrome, Pain, Fatigue, Attention, Meditation

Brief summary

This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at equivalent time points for veterans randomized to TAU only. Following completion of all study activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.

Detailed description

A randomized controlled trial with two arms. 55 veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to standard care or standard care plus an 8-week course of course of Mindfulness-Based Stress Reduction (MBSR). Study measures were collected at baseline, immediate post-MBSR (within one week of completion of the MBSR class) and 6 months following completion of the MBSR course. Measures were obtained at equivalent time points for veterans randomized to usual care only. Following completion, veterans randomized to standard care only had the opportunity to enroll in MBSR. This pilot study will whether there is sufficient evidence of benefit to warrant further study, and gathered data that will allow estimation of the sample size needed in future studies. We also obtained measures working memory and attention, in addition to patient self-report measures of symptoms, in order to provide additional assessment of whether MBSR is effective. This project is prerequisite to a larger study.

Interventions

BEHAVIORALMindfulness-based stress reduction

Mindfulness-Based Stress Reduction (MBSR) teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Chart Diagnosis of PTSD

Exclusion criteria

* any past or present psychiatric disorder involving a history of psychosis (schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specified, etc.) * Mania or poorly controlled bipolar * Current suicidal or homicidal ideation * Prior training in mindfulness meditation * Active substance abuse or dependence * Must not have had an inpatient admission for psychiatric reasons within the past month

Design outcomes

Primary

MeasureTime frameDescription
Cognitive Failures Questionnaire2 monthsThe Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. Do you find you forget why you went from one part of the house to another?), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.
The Short-form McGill Pain Questionnaire2 monthsThe Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.
The Short-Form McGill Pain Questionnaire8 monthsThe Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.
Multidimensional Fatigue Inventory - General Fatigue2 monthsThe Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome.

Secondary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)2 monthsThe Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. feeling tired or having little energy), from not at all (0), to nearly every day (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.
PTSD Symptom Severity Interview (PSSI)2 monthsThe PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?) by indicating how often per week he or she experiences that symptom. For each item, not at all is scored as 0; once per week or less/a little is scored as 1; 2 to 4 times per week/somewhat is scored as 2; and 5 or more times per week/very much is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.
PROMIS Fatigue2 monthsThe self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. How often did you feel tired?) with the following scale: 1. = never 2. = rarely 3. = sometimes 4. = often 5. = always Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue.
Five Facet Mindfulness Questionnaire2 monthsThe Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. I disapprove of myself when I have irrational ideas) by indicating how often they agree with the statement on a scale of 1 (never or very rarely true) to 5 (very often or always true). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Participants in this arm undergo the mindfulness training intervention through taking part in Mindfulness-Based Stress Reduction. Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon.
26
Arm 2
Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
29
Total55

Baseline characteristics

CharacteristicArm 1Arm 2Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants0 Participants1 Participants
Age, Categorical
Between 18 and 65 years
25 Participants29 Participants54 Participants
Age, Continuous51.3 years
STANDARD_DEVIATION 6.8
48.6 years
STANDARD_DEVIATION 7.4
49.9 years
STANDARD_DEVIATION 6
Cognitive Failures Questionnaire59.6 units on a scale
STANDARD_DEVIATION 16.5
58.3 units on a scale
STANDARD_DEVIATION 18.7
58.9 units on a scale
STANDARD_DEVIATION 17.5
Gastrointestinal Condition
Current GI condition diagnosis
10 participants19 participants29 participants
Gastrointestinal Condition
No GI condition diagnosis
16 participants10 participants26 participants
McGill Pain Questionnaire score75 units on a scale
STANDARD_DEVIATION 32.5
81.2 units on a scale
STANDARD_DEVIATION 41.9
77.1 units on a scale
STANDARD_DEVIATION 31.3
Medication Use at Baseline
Amphetamine
2 participants3 participants5 participants
Medication Use at Baseline
Antidepressant
13 participants14 participants27 participants
Medication Use at Baseline
Benzodiazepine
4 participants4 participants8 participants
Medication Use at Baseline
Opiate
14 participants5 participants19 participants
Multidimensional Fatigue Inventory
General Fatigue
16.0 units on a scale
STANDARD_DEVIATION 2.8
15.5 units on a scale
STANDARD_DEVIATION 3.2
15.8 units on a scale
STANDARD_DEVIATION 3
Multidimensional Fatigue Inventory
Mental Fatigue
15.5 units on a scale
STANDARD_DEVIATION 3.6
15.6 units on a scale
STANDARD_DEVIATION 3.2
15.5 units on a scale
STANDARD_DEVIATION 3.3
Multidimensional Fatigue Inventory
Physical Fatigue
14.4 units on a scale
STANDARD_DEVIATION 2.7
15.3 units on a scale
STANDARD_DEVIATION 2.9
14.9 units on a scale
STANDARD_DEVIATION 2.8
Multidimensional Fatigue Inventory
Reduced Activity
14.9 units on a scale
STANDARD_DEVIATION 4.1
14.3 units on a scale
STANDARD_DEVIATION 3.8
14.6 units on a scale
STANDARD_DEVIATION 3.9
Multidimensional Fatigue Inventory
Reduced Motivation
11.5 units on a scale
STANDARD_DEVIATION 2.4
11.6 units on a scale
STANDARD_DEVIATION 2.4
11.5 units on a scale
STANDARD_DEVIATION 2.4
Musculoskeletal Pain
Current musculoskeletal pain diagnosis
20 participants27 participants47 participants
Musculoskeletal Pain
No musculoskeletal pain diagnosis
6 participants2 participants8 participants
Neurologic Pain
Current neurologic pain diagnosis
14 participants15 participants29 participants
Neurologic Pain
No neurologic pain diagnosis
12 participants14 participants26 participants
PTSD Symptom Scale Interview29 units on a scale
STANDARD_DEVIATION 11.2
26.2 units on a scale
STANDARD_DEVIATION 10.6
27.5 units on a scale
STANDARD_DEVIATION 10.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
2 Participants8 Participants10 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants1 Participants7 Participants
Race (NIH/OMB)
White
17 Participants17 Participants34 Participants
Region of Enrollment
United States
26 participants29 participants55 participants
Respiratory Conditions
Current respiratory condition diagnosis
10 participants12 participants22 participants
Respiratory Conditions
No respiratory condition diagnosis
16 participants17 participants33 participants
Sex: Female, Male
Female
3 Participants5 Participants8 Participants
Sex: Female, Male
Male
23 Participants24 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 260 / 29
serious
Total, serious adverse events
0 / 262 / 29

Outcome results

Primary

Cognitive Failures Questionnaire

The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. Do you find you forget why you went from one part of the house to another?), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.

Time frame: 8 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Cognitive Failures Questionnaire46.6 units on a scaleStandard Deviation 15.4
Arm 2Cognitive Failures Questionnaire61.9 units on a scaleStandard Deviation 18.6
Primary

Cognitive Failures Questionnaire

The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. Do you find you forget why you went from one part of the house to another?), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Cognitive Failures Questionnaire46.9 units on a scaleStandard Deviation 18.1
Arm 2Cognitive Failures Questionnaire58.6 units on a scaleStandard Deviation 18.1
Primary

Multidimensional Fatigue Inventory - General Fatigue

The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Multidimensional Fatigue Inventory - General Fatigue14.9 units on a scaleStandard Deviation 3.6
Arm 2Multidimensional Fatigue Inventory - General Fatigue15.5 units on a scaleStandard Deviation 2.9
Primary

Multidimensional Fatigue Inventory - General Fatigue

The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome.

Time frame: 8 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Multidimensional Fatigue Inventory - General Fatigue13.6 units on a scaleStandard Deviation 3.4
Arm 2Multidimensional Fatigue Inventory - General Fatigue15.3 units on a scaleStandard Deviation 3.6
Primary

The Short-form McGill Pain Questionnaire

The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Arm 1The Short-form McGill Pain Questionnaire54.0 units on a scaleStandard Deviation 44.2
Arm 2The Short-form McGill Pain Questionnaire65.5 units on a scaleStandard Deviation 43.4
Primary

The Short-Form McGill Pain Questionnaire

The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.

Time frame: 8 months

ArmMeasureValue (MEAN)Dispersion
Arm 1The Short-Form McGill Pain Questionnaire57.1 units on a scaleStandard Deviation 44.7
Arm 2The Short-Form McGill Pain Questionnaire76.6 units on a scaleStandard Deviation 49.3
Secondary

Five Facet Mindfulness Questionnaire

The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. I disapprove of myself when I have irrational ideas) by indicating how often they agree with the statement on a scale of 1 (never or very rarely true) to 5 (very often or always true). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.

Time frame: 8 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Five Facet Mindfulness Questionnaire129.4 units on a scaleStandard Deviation 22.4
Arm 2Five Facet Mindfulness Questionnaire114.6 units on a scaleStandard Deviation 19.6
Secondary

Five Facet Mindfulness Questionnaire

The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. I disapprove of myself when I have irrational ideas) by indicating how often they agree with the statement on a scale of 1 (never or very rarely true) to 5 (very often or always true). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Five Facet Mindfulness Questionnaire126.5 units on a scaleStandard Deviation 22.7
Arm 2Five Facet Mindfulness Questionnaire115.0 units on a scaleStandard Deviation 15.1
Secondary

Patient Health Questionnaire (PHQ-9)

The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. feeling tired or having little energy), from not at all (0), to nearly every day (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Patient Health Questionnaire (PHQ-9)10.2 units on a scaleStandard Deviation 6.2
Arm 2Patient Health Questionnaire (PHQ-9)12.4 units on a scaleStandard Deviation 6.7
Secondary

Patient Health Questionnaire (PHQ-9)

The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. feeling tired or having little energy), from not at all (0), to nearly every day (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.

Time frame: 8 months

ArmMeasureValue (MEAN)Dispersion
Arm 1Patient Health Questionnaire (PHQ-9)9.5 units on a scaleStandard Deviation 4.7
Arm 2Patient Health Questionnaire (PHQ-9)12.3 units on a scaleStandard Deviation 6.8
Secondary

PROMIS Fatigue

The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. How often did you feel tired?) with the following scale: 1. = never 2. = rarely 3. = sometimes 4. = often 5. = always Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Arm 1PROMIS Fatigue56.0 T-scoreStandard Deviation 8.6
Arm 2PROMIS Fatigue61.5 T-scoreStandard Deviation 9.3
Secondary

PROMIS Fatigue

The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. How often did you feel tired?) with the following scale: 1. = never 2. = rarely 3. = sometimes 4. = often 5. = always Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue.

Time frame: 8 months

ArmMeasureValue (MEAN)Dispersion
Arm 1PROMIS Fatigue57.5 T-scoreStandard Deviation 9.6
Arm 2PROMIS Fatigue62.0 T-scoreStandard Deviation 10
Secondary

PTSD Symptom Severity Interview (PSSI)

The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?) by indicating how often per week he or she experiences that symptom. For each item, not at all is scored as 0; once per week or less/a little is scored as 1; 2 to 4 times per week/somewhat is scored as 2; and 5 or more times per week/very much is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Arm 1PTSD Symptom Severity Interview (PSSI)20.7 units on a scaleStandard Deviation 9.1
Arm 2PTSD Symptom Severity Interview (PSSI)24.7 units on a scaleStandard Deviation 10.2
Secondary

PTSD Symptom Severity Interview (PSSI)

The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?) by indicating how often per week he or she experiences that symptom. For each item, not at all is scored as 0; once per week or less/a little is scored as 1; 2 to 4 times per week/somewhat is scored as 2; and 5 or more times per week/very much is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.

Time frame: 8 months

ArmMeasureValue (MEAN)Dispersion
Arm 1PTSD Symptom Severity Interview (PSSI)21.7 units on a scaleStandard Deviation 10.8
Arm 2PTSD Symptom Severity Interview (PSSI)23.6 units on a scaleStandard Deviation 10.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026