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

The Effect of Acupuncture on PTSD-Related Insomnia

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.

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic
• Intervention / Treatment: Other: True group auricular acupuncture; Other: Sham group auricular acupuncture; Other: Wait-List Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC VA Medical Center, Washington, DC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: True Group Auricular Acupuncture; Received true group auricular acupuncture twice weekly for a period of two months.	Other: True group auricular acupuncture; Received true group auricular acupuncture
Sham Comparator: Sham Group Auricular Acupuncture; Received sham group auricular acupuncture twice weekly for a period of two months.	Other: Sham group auricular acupuncture; Received sham auricular acupuncture.
Other: Wait-List Control Group; Served as wait list control. Did not receive any acupuncture during the study period.	Other: Wait-List Control Group; Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Attrition Rates	Examined attendance rates in attending group sessions to examine attrition rates.	t=2 months
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-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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Michelle Kennedy Prisco, MSN BC-ANP, Washington DC VA Medical Center, Washington, DC

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Acupuncture; Veterans; Complementary Therapies; Combat Disorders; Operation Iraqi Freedom; Operation Enduring Freedom
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Trauma and Stressor Related Disorders; Disease; Sleep Initiation and Maintenance Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: NRI 08-121