Post Traumatic Stress Disorder, Sleep Disturbance
Conditions
Keywords
Post Traumatic Stress Disorder, Sleep Disturbance, Acupuncture
Brief summary
Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. The purpose of this research will be to conduct a prospective, randomized, wait list controlled, small scale feasibility study to examine if the use of an auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or standard therapy alone.
Interventions
DEVICEAuricular Acupuncture
Subjects receiving the auricular acupuncture intervention will be treated in a quiet private room sitting in a comfortable chair. The external ear cartilage of both ears will be cleaned with isopropyl alcohol swabs. A clean insertion technique will be used with stainless steel SEIRIN D type acupuncture needles (0.20mm diameter, 15mm length) on each of the identified acupuncture points (Shen men, Point zero, brain, thalamus, Pineal, Master cerebral, Insomnia 1, Kidney, Heart, Insomnia 2, Occiput, Forehead) to bilateral ears for a total of 30 minutes. Acupuncture will be administered by a board certified Psychiatrist with supplemental privileges to perform acupuncture.
Sponsors
United States Department of Defense
United States Naval Medical Center, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-50 years * Male gender * veteran of OIF/OEF * comorbid mental health problems such as depression, anxiety are allowed * self-reported sleep disturbance (defined as having one or more of the following-sleep onset latency greater than 30 minutes, two or more awakenings per night, total sleep time less than six hours per night, presence of nightmares. * sleep disturbances must have started after a deployment
Exclusion criteria
* Axis I mental disorders incompatible with active military service * History of moderate to severe traumatic brain injury * Sleep Apnea * Current use of Continuous Positive Airway Pressure Devices * Significant Co-morbid conditions (heart, lung, liver disease, etc.) * Other treatment programs that involve cognitive processing therapy * No concurrent use of acupuncture during study * taking any anticoagulation medication * essential tremors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Acupuncture as a Treatment for Sleep Disturbance | One month | Acceptability of Acupuncture as a treatment for sleep disturbance will be measured at one month by a likert type question. |
| Change in Objective Sleep Times | Baseline (upon entering study) and at one month | Change in sleep times will be measured by actigraphy for seven days at baseline and again for seven days at one month. |
| Change in Subjective Sleep Times | Baseline (upon entering study) and at one month | Change in subjective sleep times will be measured by sleep diary for one week at baseline and again for seven days at one month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post Traumatic Stress Disorder Symptoms | Baseline (upon enterning the study) and week 3 & at week 5 | Change in Post Traumatic Stress Disorder Symptoms will be measured by the Post Traumatic Stress Disorder Checklist at baseline, at week 3, and at week 5. |
| Change in Sleep Quality | Baseline (upon entering study) and at one month | Change in sleep quality will be measured by Pittsburgh Sleep Quality Index Scores at baseline and at one month |
| Change in Depression | Baseline (upon entering study) and at week 3 & at week 5 | Change in depression will be measured by Patient Health Questionnaire, version 9 (PHQ-9) scores at baseline, at week 3, and at week 5. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjects Feedback on Study | Week 5 | An open ended question will examine subject feedback regarding this study. |
Countries
United States
Outcome results
None listed