Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder

Study Overview
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Brief Summary
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The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study also examined the degree of veteran acceptance for a group ear acupuncture procedure.

Detailed Description
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Background: Approximately 70-91% of veterans with Post-Traumatic Stress Disorder (PTSD) report insomnia. Presently, conventional treatments for PTSD-related insomnia include medications, psychotherapy, and cognitive behavioral therapy. While some of these conventional treatments do improve PTSD-related insomnia, many of these treatments have limitations (e.g., medication effects, lengthy time commitments, psycho-social stigma). Because of these limitations, many veterans are increasingly turning to complementary and alternative therapies to relieve their symptoms. There is a growing body of research that shows that acupuncture may improve many health symptoms including depression, PTSD, addiction, headaches, musculoskeletal pain, and insomnia. However, to date, no study has specifically explored how acupuncture may affect PTSD-related insomnia. Because so many veterans with PTSD experience PTSD-related insomnia, and because the current conflicts in Southwest Asia are producing a new generation of combat veterans, it is critical that the VA explore innovative treatments for PTSD-related health concerns.

Official Title
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The Effect of Acupuncture on PTSD-Related Insomnia

Conditions
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Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Other: True group auricular acupuncture
* Other: Sham group auricular acupuncture
* Other: Wait-List Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts; Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria; Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI); Diagnosis of insomnia made after PTSD diagnosis; and If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study. Exclusion Criteria: Does not speak English; Not competent to sign informed consent; History of moderate or severe traumatic brain injury Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study. Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis; History of substance abuse Dependence (as defined per DSM IV criteria) during the one year preceding enrollment in the study OR history of illicit substance use for 3 months prior to study enrollment OR positive Audit C score at study enrollment (defined as score of 5 and above). Received acupuncture during past 3 months. On Coumadin, Heparin, or Lovenox Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: True Group Auricular Acupuncture<br>Received true group auricular acupuncture twice weekly for a period of two months. | Other: True group auricular acupuncture<br>* Received true group auricular acupuncture<br>|
| Sham Comparator: Sham Group Auricular Acupuncture<br>Received sham group auricular acupuncture twice weekly for a period of two months. | Other: Sham group auricular acupuncture<br>* Received sham auricular acupuncture.<br>|
| Other: Wait-List Control Group<br>Served as wait list control. Did not receive any acupuncture during the study period. | Other: Wait-List Control Group<br>* Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Sleep Quality | Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings. ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of > 8 is indicative of probable insomnia. The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality. | t=2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data. | t=2 months | 
| Hypnotic Medication Use | Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD). | t=2 months | 
| Attrition Rates | Examined attendance rates in attending group sessions to examine attrition rates. | t=2 months | 
| Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture |  | t= 2 months | 
| Fragmented Sleep Patterns-Sleep Efficiency | Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data. | t=2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, Operation Iraqi Freedom, Operation Enduring Freedom, Combat Disorders, Acupuncture, Complementary Therapies