Trial Outcomes & Findings for Mindfulness-Based Stress Reduction for Gulf War Syndrome (NCT NCT01267045)
NCT ID: 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.
COMPLETED
NA
55 participants
2 months
2015-08-07
Participant Flow
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
| 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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 6.8 • n=99 Participants
|
48.6 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
49.9 years
STANDARD_DEVIATION 6.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
29 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
McGill Pain Questionnaire score
|
75 units on a scale
STANDARD_DEVIATION 32.5 • n=99 Participants
|
81.2 units on a scale
STANDARD_DEVIATION 41.9 • n=107 Participants
|
77.1 units on a scale
STANDARD_DEVIATION 31.3 • n=206 Participants
|
|
Multidimensional Fatigue Inventory
General Fatigue
|
16.0 units on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
|
15.5 units on a scale
STANDARD_DEVIATION 3.2 • n=107 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 3.0 • n=206 Participants
|
|
Multidimensional Fatigue Inventory
Physical Fatigue
|
14.4 units on a scale
STANDARD_DEVIATION 2.7 • n=99 Participants
|
15.3 units on a scale
STANDARD_DEVIATION 2.9 • n=107 Participants
|
14.9 units on a scale
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
Multidimensional Fatigue Inventory
Reduced Activity
|
14.9 units on a scale
STANDARD_DEVIATION 4.1 • n=99 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 3.8 • n=107 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
Multidimensional Fatigue Inventory
Reduced Motivation
|
11.5 units on a scale
STANDARD_DEVIATION 2.4 • n=99 Participants
|
11.6 units on a scale
STANDARD_DEVIATION 2.4 • n=107 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Multidimensional Fatigue Inventory
Mental Fatigue
|
15.5 units on a scale
STANDARD_DEVIATION 3.6 • n=99 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 3.2 • n=107 Participants
|
15.5 units on a scale
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
Cognitive Failures Questionnaire
|
59.6 units on a scale
STANDARD_DEVIATION 16.5 • n=99 Participants
|
58.3 units on a scale
STANDARD_DEVIATION 18.7 • n=107 Participants
|
58.9 units on a scale
STANDARD_DEVIATION 17.5 • n=206 Participants
|
|
PTSD Symptom Scale Interview
|
29 units on a scale
STANDARD_DEVIATION 11.2 • n=99 Participants
|
26.2 units on a scale
STANDARD_DEVIATION 10.6 • n=107 Participants
|
27.5 units on a scale
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Medication Use at Baseline
Opiate
|
14 participants
n=99 Participants
|
5 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Medication Use at Baseline
Antidepressant
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Medication Use at Baseline
Benzodiazepine
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Medication Use at Baseline
Amphetamine
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Musculoskeletal Pain
Current musculoskeletal pain diagnosis
|
20 participants
n=99 Participants
|
27 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Musculoskeletal Pain
No musculoskeletal pain diagnosis
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Neurologic Pain
Current neurologic pain diagnosis
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Neurologic Pain
No neurologic pain diagnosis
|
12 participants
n=99 Participants
|
14 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Gastrointestinal Condition
Current GI condition diagnosis
|
10 participants
n=99 Participants
|
19 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Gastrointestinal Condition
No GI condition diagnosis
|
16 participants
n=99 Participants
|
10 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Respiratory Conditions
Current respiratory condition diagnosis
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Respiratory Conditions
No respiratory condition diagnosis
|
16 participants
n=99 Participants
|
17 participants
n=107 Participants
|
33 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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
Arm 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place