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

NCT ID: NCT00868517

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

True Group Auricular Acupuncture

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

Group Type: EXPERIMENTAL

True group auricular acupuncture

Intervention Type: OTHER

Received true group auricular acupuncture

Sham Group Auricular Acupuncture

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

Group Type: SHAM_COMPARATOR

Sham group auricular acupuncture

Intervention Type: OTHER

Received sham auricular acupuncture.

Wait-List Control Group

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

Group Type: OTHER

Wait-List Control Group

Intervention Type: OTHER

Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.

Interventions

True group auricular acupuncture

Received true group auricular acupuncture

Intervention Type: OTHER

Sham group auricular acupuncture

Received sham auricular acupuncture.

Intervention Type: OTHER

Wait-List Control Group

Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Kennedy Prisco, MSN BC-ANP

Role: PRINCIPAL_INVESTIGATOR

Washington DC VA Medical Center, Washington, DC

Locations

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

NRI 08-121

Identifier Type: -

Identifier Source: org_study_id