Trial Outcomes & Findings for Mindfulness-Based Stress Reduction for Gulf War Syndrome (NCT NCT01267045)

Last Updated: 2015-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

2 months

Results posted on

2015-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction. Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a class series 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.	Arm 2 Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
2-month Outcomes STARTED	26	29
2-month Outcomes COMPLETED	22	26
2-month Outcomes NOT COMPLETED	4	3
6-month Outcome STARTED	22	26
6-month Outcome COMPLETED	22	23
6-month Outcome NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness-Based Stress Reduction for Gulf War Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=26 Participants 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.	Arm 2 n=29 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	51.3 years STANDARD_DEVIATION 6.8 • n=5 Participants	48.6 years STANDARD_DEVIATION 7.4 • n=7 Participants	49.9 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	29 participants n=7 Participants	55 participants n=5 Participants
McGill Pain Questionnaire score	75 units on a scale STANDARD_DEVIATION 32.5 • n=5 Participants	81.2 units on a scale STANDARD_DEVIATION 41.9 • n=7 Participants	77.1 units on a scale STANDARD_DEVIATION 31.3 • n=5 Participants
Multidimensional Fatigue Inventory General Fatigue	16.0 units on a scale STANDARD_DEVIATION 2.8 • n=5 Participants	15.5 units on a scale STANDARD_DEVIATION 3.2 • n=7 Participants	15.8 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants
Multidimensional Fatigue Inventory Physical Fatigue	14.4 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants	15.3 units on a scale STANDARD_DEVIATION 2.9 • n=7 Participants	14.9 units on a scale STANDARD_DEVIATION 2.8 • n=5 Participants
Multidimensional Fatigue Inventory Reduced Activity	14.9 units on a scale STANDARD_DEVIATION 4.1 • n=5 Participants	14.3 units on a scale STANDARD_DEVIATION 3.8 • n=7 Participants	14.6 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants
Multidimensional Fatigue Inventory Reduced Motivation	11.5 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants	11.6 units on a scale STANDARD_DEVIATION 2.4 • n=7 Participants	11.5 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants
Multidimensional Fatigue Inventory Mental Fatigue	15.5 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants	15.6 units on a scale STANDARD_DEVIATION 3.2 • n=7 Participants	15.5 units on a scale STANDARD_DEVIATION 3.3 • n=5 Participants
Cognitive Failures Questionnaire	59.6 units on a scale STANDARD_DEVIATION 16.5 • n=5 Participants	58.3 units on a scale STANDARD_DEVIATION 18.7 • n=7 Participants	58.9 units on a scale STANDARD_DEVIATION 17.5 • n=5 Participants
PTSD Symptom Scale Interview	29 units on a scale STANDARD_DEVIATION 11.2 • n=5 Participants	26.2 units on a scale STANDARD_DEVIATION 10.6 • n=7 Participants	27.5 units on a scale STANDARD_DEVIATION 10.9 • n=5 Participants
Medication Use at Baseline Opiate	14 participants n=5 Participants	5 participants n=7 Participants	19 participants n=5 Participants
Medication Use at Baseline Antidepressant	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Medication Use at Baseline Benzodiazepine	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Medication Use at Baseline Amphetamine	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Musculoskeletal Pain Current musculoskeletal pain diagnosis	20 participants n=5 Participants	27 participants n=7 Participants	47 participants n=5 Participants
Musculoskeletal Pain No musculoskeletal pain diagnosis	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants
Neurologic Pain Current neurologic pain diagnosis	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Neurologic Pain No neurologic pain diagnosis	12 participants n=5 Participants	14 participants n=7 Participants	26 participants n=5 Participants
Gastrointestinal Condition Current GI condition diagnosis	10 participants n=5 Participants	19 participants n=7 Participants	29 participants n=5 Participants
Gastrointestinal Condition No GI condition diagnosis	16 participants n=5 Participants	10 participants n=7 Participants	26 participants n=5 Participants
Respiratory Conditions Current respiratory condition diagnosis	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants
Respiratory Conditions No respiratory condition diagnosis	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=26 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
The Short-form McGill Pain Questionnaire	54.0 units on a scale Standard Deviation 44.2	65.5 units on a scale Standard Deviation 43.4

PRIMARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=23 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
The Short-Form McGill Pain Questionnaire	57.1 units on a scale Standard Deviation 44.7	76.6 units on a scale Standard Deviation 49.3

PRIMARY outcome

Timeframe: 2 months

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.

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=26 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Multidimensional Fatigue Inventory - General Fatigue	14.9 units on a scale Standard Deviation 3.6	15.5 units on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=23 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Multidimensional Fatigue Inventory - General Fatigue	13.6 units on a scale Standard Deviation 3.4	15.3 units on a scale Standard Deviation 3.6

PRIMARY outcome

Timeframe: 2 months

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.

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=26 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Cognitive Failures Questionnaire	46.9 units on a scale Standard Deviation 18.1	58.6 units on a scale Standard Deviation 18.1

PRIMARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=23 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Cognitive Failures Questionnaire	46.6 units on a scale Standard Deviation 15.4	61.9 units on a scale Standard Deviation 18.6

SECONDARY outcome

Timeframe: 2 months

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.

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=26 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Patient Health Questionnaire (PHQ-9)	10.2 units on a scale Standard Deviation 6.2	12.4 units on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=23 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Patient Health Questionnaire (PHQ-9)	9.5 units on a scale Standard Deviation 4.7	12.3 units on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: 2 months

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.

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=26 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
PTSD Symptom Severity Interview (PSSI)	20.7 units on a scale Standard Deviation 9.1	24.7 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=23 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
PTSD Symptom Severity Interview (PSSI)	21.7 units on a scale Standard Deviation 10.8	23.6 units on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: 2 months

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.

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=26 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
PROMIS Fatigue	56.0 T-score Standard Deviation 8.6	61.5 T-score Standard Deviation 9.3

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=23 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
PROMIS Fatigue	57.5 T-score Standard Deviation 9.6	62.0 T-score Standard Deviation 10.0

SECONDARY outcome

Timeframe: 2 months

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.

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=26 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Five Facet Mindfulness Questionnaire	126.5 units on a scale Standard Deviation 22.7	115.0 units on a scale Standard Deviation 15.1

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Outcome measures
Measure	Arm 1 n=22 Participants Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course The most 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.	Arm 2 n=23 Participants Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Five Facet Mindfulness Questionnaire	129.4 units on a scale Standard Deviation 22.4	114.6 units on a scale Standard Deviation 19.6

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=26 participants at risk Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course. The most 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 b	Arm 2 n=29 participants at risk Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Cardiac disorders Chest pains	0.00% 0/26	3.4% 1/29 • Number of events 1
Psychiatric disorders Suicidal ideation	0.00% 0/26	3.4% 1/29 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

David J. Kearney, MD

VA Puget Sound Health Care System

Phone: 206-277-1445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place