Mindfulness-Based Stress Reduction for Gulf War Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01267045
First received: December 23, 2010
Last updated: December 15, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Persian Gulf Syndrome
Behavioral: Mindfulness-based stress reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Mindfulness Based Intervention for Gulf War Syndrome

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The Short-form McGill Pain Questionnaire [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  • The Short-Form McGill Pain Questionnaire [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.

  • Multidimensional Fatigue Inventory - General Fatigue [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  • Multidimensional Fatigue Inventory - General Fatigue [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.

  • Cognitive Failures Questionnaire [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  • Cognitive Failures Questionnaire [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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.

  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    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.

  • PTSD Symptom Severity Interview (PSSI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  • PTSD Symptom Severity Interview (PSSI) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.

  • PROMIS Fatigue [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    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.


  • PROMIS Fatigue [ Time Frame: 8 months ] [ Designated as safety issue: No ]

    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.


  • Five Facet Mindfulness Questionnaire [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  • Five Facet Mindfulness Questionnaire [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 55
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
Behavioral: Mindfulness-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.
No Intervention: Arm 2
Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Were deployed to the Gulf War theater of operations between Aug. 1990 and Aug. 1991

Report at least two of the following:

  • Fatigue
  • Musculoskeletal pain
  • neuro-cognitive dysfunction

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267045

Locations
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Principal Investigator: David J. Kearney, MD VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
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: December 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Persian Gulf Syndrome
Pain
Fatigue
Attention
Meditation

Additional relevant MeSH terms:
Persian Gulf Syndrome
Syndrome
Disease
Occupational Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2015