Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
- Conditions
- Sleep DisturbancePost Traumatic Stress Disorder
- Interventions
- Device: Auricular Acupuncture
- Registration Number
- NCT01862653
- Lead Sponsor
- United States Naval Medical Center, San Diego
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Auricular Acupuncture Auricular Acupuncture An insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group.
- Primary Outcome Measures
Name Time Method 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
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.
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.
- Secondary Outcome Measures
Name Time Method 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 ratings will also be measured by the consensus sleep diary sleep quality ratings 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.
Trial Locations
- Locations (1)
Overcoming Adversity and Stress and Injury Support Clinic
🇺🇸San Diego, California, United States