Mindfulness-Based Stress Reduction for Gulf War Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01267045
First received: December 23, 2010
Last updated: July 20, 2015
Last verified: July 2015
Results First Received: November 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Persian Gulf Syndrome
Intervention: Behavioral: Mindfulness-based stress reduction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.)

Participant Flow for 2 periods

Period 1:   2-month Outcomes
    Arm 1   Arm 2
STARTED   26   29 
COMPLETED   22   26 
NOT COMPLETED   4   3 

Period 2:   6-month Outcome
    Arm 1   Arm 2
STARTED   22   26 
COMPLETED   22   23 
NOT COMPLETED   0   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Arm 2 Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   29   55 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   25   29   54 
>=65 years   1   0   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.3  (6.8)   48.6  (7.4)   49.9  (6.0) 
Gender 
[Units: Participants]
     
Female   3   5   8 
Male   23   24   47 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   1   2   3 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   2   8   10 
White   17   17   34 
More than one race   0   0   0 
Unknown or Not Reported   6   1   7 
Region of Enrollment 
[Units: Participants]
     
United States   26   29   55 
McGill Pain Questionnaire score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 75  (32.5)   81.2  (41.9)   77.1  (31.3) 
[1] 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.
Multidimensional Fatigue Inventory [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
General Fatigue   16.0  (2.8)   15.5  (3.2)   15.8  (3.0) 
Physical Fatigue   14.4  (2.7)   15.3  (2.9)   14.9  (2.8) 
Reduced Activity   14.9  (4.1)   14.3  (3.8)   14.6  (3.9) 
Reduced Motivation   11.5  (2.4)   11.6  (2.4)   11.5  (2.4) 
Mental Fatigue   15.5  (3.6)   15.6  (3.2)   15.5  (3.3) 
[1] 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.")
Cognitive Failures Questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 59.6  (16.5)   58.3  (18.7)   58.9  (17.5) 
[1] 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).
PTSD Symptom Scale Interview 
[Units: Units on a scale]
Mean (Standard Deviation)
 29  (11.2)   26.2  (10.6)   27.5  (10.9) 
Medication Use at Baseline [1] 
[Units: Participants]
     
Opiate   14   5   19 
Antidepressant   13   14   27 
Benzodiazepine   4   4   8 
Amphetamine   2   3   5 
[1] This is a summary of the prevalence of medication use among the study participants. Since each participant could endorse anywhere from none of these medications to all four types of medication, the total number is unlikely to add up to the exact number of participants.
Musculoskeletal Pain 
[Units: Participants]
     
Current musculoskeletal pain diagnosis   20   27   47 
No musculoskeletal pain diagnosis   6   2   8 
Neurologic Pain 
[Units: Participants]
     
Current neurologic pain diagnosis   14   15   29 
No neurologic pain diagnosis   12   14   26 
Gastrointestinal Condition 
[Units: Participants]
     
Current GI condition diagnosis   10   19   29 
No GI condition diagnosis   16   10   26 
Respiratory Conditions 
[Units: Participants]
     
Current respiratory condition diagnosis   10   12   22 
No respiratory condition diagnosis   16   17   33 


  Outcome Measures
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1.  Primary:   The Short-form McGill Pain Questionnaire   [ Time Frame: 2 months ]

2.  Primary:   The Short-Form McGill Pain Questionnaire   [ Time Frame: 8 months ]

3.  Primary:   Multidimensional Fatigue Inventory - General Fatigue   [ Time Frame: 2 months ]

4.  Primary:   Multidimensional Fatigue Inventory - General Fatigue   [ Time Frame: 8 months ]

5.  Primary:   Cognitive Failures Questionnaire   [ Time Frame: 2 months ]

6.  Primary:   Cognitive Failures Questionnaire   [ Time Frame: 8 months ]

7.  Secondary:   Patient Health Questionnaire (PHQ-9)   [ Time Frame: 2 months ]

8.  Secondary:   Patient Health Questionnaire (PHQ-9)   [ Time Frame: 8 months ]

9.  Secondary:   PTSD Symptom Severity Interview (PSSI)   [ Time Frame: 2 months ]

10.  Secondary:   PTSD Symptom Severity Interview (PSSI)   [ Time Frame: 8 months ]

11.  Secondary:   PROMIS Fatigue   [ Time Frame: 2 months ]

12.  Secondary:   PROMIS Fatigue   [ Time Frame: 8 months ]

13.  Secondary:   Five Facet Mindfulness Questionnaire   [ Time Frame: 2 months ]

14.  Secondary:   Five Facet Mindfulness Questionnaire   [ Time Frame: 8 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David J. Kearney, MD
Organization: VA Puget Sound Health Care System
phone: 206-277-1445
e-mail: David.Kearney@VA.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01267045     History of Changes
Other Study ID Numbers: SPLD-008-10S
Study First Received: December 23, 2010
Results First Received: November 4, 2014
Last Updated: July 20, 2015