Clinical trial NCT01543997: Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms
Official title: Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disturbance
Persian Gulf War Syndrome in Veteran
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: VA Salt Lake City Health Care System
name: United States Department of Defense
First posted: 2012-03-05
Enrollment: 75
Sex: ALL
Minimum age (years): 38
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate clinical benefits of a novel sleep-focused mind-body program on Gulf War Illness (GWI) symptoms.

Detailed description: This randomized study investigates whether two treatment conditions:Mind-Body Bridging (MBB) and Supportive Education (SED) are effective in improving sleep disturbance and self-reported indicators of other co-morbid symptoms in veterans with GWI. The two treatment conditions will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).

Eligibility criteria: Inclusion Criteria:

* Veteran from First Gulf War
* Suffering from sleep disturbance
* Has other chronic symptoms of Gulf War Illness:

  * fatigue
  * chronic headaches
  * joint/muscle pain
  * cognitive difficulties
  * memory/concentration problems
  * shortness of breath
  * gastrointestinal symptoms

Exclusion Criteria:

* terminally ill
* a highly unstable medical or psychiatric condition
* Parkinson disease
* dementia of any cause
* Nocturia
* delayed/advanced sleep phase syndrome
* Narcolepsy

Primary outcomes:
measure: Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
timeFrame: Week1, Week2, Week 3, Week 4, Week 15
measure: Change from baseline in the measure of the Sleep Diary
timeFrame: Week2, Week 4, Week 15
Secondary outcomes:
measure: Pain
timeFrame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
measure: Fatigue
timeFrame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
measure: Cognitive functioning
timeFrame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
measure: Mindfulness
timeFrame: Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)
measure: Health-related quality of life
timeFrame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
measure: PTSD
timeFrame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
measure: Depression
timeFrame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
measure: Psychological symptoms
timeFrame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Pain Research Center
state: Utah
city: Salt Lake City
country: United States
facility: VA SLC Health Care System
state: Utah
Study officials:
affiliation: University of Utah
name: Yoshio Nakamura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakamura Y, Lipschitz DL, Donaldson GW, Kida Y, Williams SL, Landward R, Glover DW, West G, Tuteja AK. Investigating Clinical Benefits of a Novel Sleep-Focused Mind-Body Program on Gulf War Illness Symptoms: A Randomized Controlled Trial. Psychosom Med. 2017 Jul/Aug;79(6):706-718. doi: 10.1097/PSY.0000000000000469.