Mindfulness-Based Stress Reduction for Gulf War Syndrome

NCT01267045 | Completed Results

• 1 other identifier: SPLD-008-10S
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Persian Gulf Syndrome

Keywords

Persian Gulf Syndrome; Pain; Fatigue; Attention; Meditation

Outcome Measures

Primary Outcomes (6)

• The Short-form McGill Pain Questionnaire

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

  2 months

• The Short-Form McGill Pain Questionnaire

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

  8 months

• Multidimensional Fatigue Inventory - General Fatigue

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

  2 months

• Multidimensional Fatigue Inventory - General Fatigue

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

  8 months

• Cognitive Failures Questionnaire

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

  2 months

• Cognitive Failures Questionnaire

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

  8 months

Secondary Outcomes (8)

• Patient Health Questionnaire (PHQ-9)

  2 months

• Patient Health Questionnaire (PHQ-9)

  8 months

• PTSD Symptom Severity Interview (PSSI)

  2 months

• PTSD Symptom Severity Interview (PSSI)

  8 months

• PROMIS Fatigue

  2 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course

Behavioral: Mindfulness-based stress reduction

Arm 2

NO INTERVENTION

Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)

Interventions

Mindfulness-based stress reduction BEHAVIORAL

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.

Arm 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chart Diagnosis of PTSD

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Persian Gulf Syndrome; Pain; Fatigue

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: David J. Kearney, MD
• Organization: VA Puget Sound Health Care System

David.Kearney@VA.gov

206-277-1445

Study Officials

• David J Kearney, MD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2014
• Last Updated: August 7, 2015
• Results First Posted: December 17, 2014

Record last verified: 2015-07

Locations

US (1)