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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

The Effect of Acupuncture on PTSD-Related Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868517
• Other study ID #: NRI 08-121
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: April 6, 2015
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Sleep Initiation and Maintenance Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• True group auricular acupuncture
Received true group auricular acupuncture
• Sham group auricular acupuncture
Received sham auricular acupuncture.
• Wait-List Control Group
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.

Locations

Country	Name	City	State
United States	Washington DC VA Medical Center, Washington, DC	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Attrition Rates	Examined attendance rates in attending group sessions to examine attrition rates.	t=2 months	No
Secondary	Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture		t= 2 months	No
Secondary	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	No