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OpenTrials
Completed

NCT Number: NCT00868517

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

True group auricular acupuncture

Other

Received true group auricular acupuncture

Sham group auricular acupuncture

Other

Received sham auricular acupuncture.

Wait-List Control Group

Other

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

Primary outcomes

  1. Perceived Sleep Quality

    Time frame: t=2 months

    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.

Secondary outcomes

  1. Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps

    Time frame: t=2 months

    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.

  2. Hypnotic Medication Use

    Time frame: t=2 months

    Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).

  3. Attrition Rates

    Time frame: t=2 months

    Examined attendance rates in attending group sessions to examine attrition rates.

  4. Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture

    Time frame: t= 2 months

  5. Fragmented Sleep Patterns-Sleep Efficiency

    Time frame: t=2 months

    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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

The Effect of Acupuncture on PTSD-Related Insomnia

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 25, 2009
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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