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

Not Applicable

Completed

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

Interventions: Other: True group auricular acupuncture
Other: Sham group auricular acupuncture
Other: Wait-List Control Group

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
True Group Auricular Acupuncture	True group auricular acupuncture	Received true group auricular acupuncture twice weekly for a period of two months.
Sham Group Auricular Acupuncture	Sham group auricular acupuncture	Received sham group auricular acupuncture twice weekly for a period of two months.
Wait-List Control Group	Wait-List Control Group	Served as wait list control. Did not receive any acupuncture during the study period.

Primary Outcome Measures

Name	Time	Method
Perceived Sleep Quality	t=2 months	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.

Secondary Outcome Measures

Name	Time	Method
Hypnotic Medication Use	t=2 months	Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).
Attrition Rates	t=2 months	Examined attendance rates in attending group sessions to examine attrition rates.
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-Total Sleep Time, Sleep Latency, and Naps	t=2 months	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.
Fragmented Sleep Patterns-Sleep Efficiency	t=2 months	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.