Persian Gulf War Syndrome in Veteran, Sleep Disturbance
Conditions
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).
Interventions
BEHAVIORALMind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
BEHAVIORALSupportive Education
This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
Sponsors
VA Salt Lake City Health Care System
United States Department of Defense
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
38 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale | Week1, Week2, Week 3, Week 4, Week 15 |
| Change from baseline in the measure of the Sleep Diary | Week2, Week 4, Week 15 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive functioning | Pre (Baseline), Post (Week4), Follow-up (Week 15) | Cognitive Failures Questionnaire |
| Mindfulness | Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15) | 5-factor M questionnaire |
| Health-related quality of life | Pre (Baseline), Post (Week4), Follow-up (Week 15) | Medical Outcomes Study Short Form-36 |
| Pain | Pre (Baseline), Post (Week4), Follow-up (Week 15) | Multidimensional Pain Inventory Pain Scale |
| Depression | Pre (Baseline), Post (Week4), Follow-up (Week 15) | Center of Epidemiological Study-Depression Scale |
| Psychological symptoms | Pre (Baseline), Post (Week4), Follow-up (Week 15) | Brief Symptom Inventory 18 |
| PTSD | Pre (Baseline), Post (Week4), Follow-up (Week 15) | PTSD Check List-Military (PCL-M) |
| Fatigue | Pre (Baseline), Post (Week4), Follow-up (Week 15) | Multidimensional Fatigue Inventory |
Countries
United States
Outcome results
None listed