Clinical trial NCT00868517: Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
Official title: The Effect of Acupuncture on PTSD-Related Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Sleep Initiation and Maintenance Disorders
Keywords: Veterans
Operation Iraqi Freedom
Operation Enduring Freedom
Combat Disorders
Acupuncture
Complementary Therapies
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-03-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Sleep Quality
timeFrame: t=2 months
Secondary outcomes:
measure: Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
timeFrame: t=2 months
measure: Hypnotic Medication Use
timeFrame: t=2 months
measure: Attrition Rates
timeFrame: t=2 months
measure: Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
timeFrame: t= 2 months
measure: Fragmented Sleep Patterns-Sleep Efficiency
timeFrame: t=2 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center, Washington, DC
name: Michelle Kennedy Prisco, MSN BC-ANP
role: PRINCIPAL_INVESTIGATOR
References: