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

US Department of Veterans Affairs (VA)

Status: Completed

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

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00868517

NRI 08-121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
2. Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
3. Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
4. Diagnosis of insomnia made after PTSD diagnosis; and
5. If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.

Exclusion criteria

1. Does not speak English;
2. Not competent to sign informed consent;
3. History of moderate or severe traumatic brain injury
4. Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
5. Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
6. 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).
7. Received acupuncture during past 3 months.
8. On Coumadin, Heparin, or Lovenox
9. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

35 participants in 3 patient groups

True Group Auricular Acupuncture

Experimental group

Description:

Received true group auricular acupuncture twice weekly for a period of two months.

Treatment:

Other: True group auricular acupuncture

Sham Group Auricular Acupuncture

Sham Comparator group

Description:

Received sham group auricular acupuncture twice weekly for a period of two months.

Treatment:

Other: Sham group auricular acupuncture

Wait-List Control Group

Other group

Description:

Served as wait list control. Did not receive any acupuncture during the study period.

Treatment:

Other: Wait-List Control Group