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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00868517
First received: March 23, 2009
Last updated: November 6, 2014
Last verified: November 2014

March 23, 2009
November 6, 2014
October 2009
September 2011   (final data collection date for primary outcome measure)
Perceived Sleep Quality [ Time Frame: t=2 months ] [ Designated as safety issue: No ]

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.

Sleep Quality rating as measured by Insomnia Severity Index and Morin Sleep diary [ Time Frame: t=0,1,2 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00868517 on ClinicalTrials.gov Archive Site
  • Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps [ Time Frame: t=2 months ] [ Designated as safety issue: No ]
    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.
  • Hypnotic Medication Use [ Time Frame: t=2 months ] [ Designated as safety issue: No ]
    Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).
  • Attrition Rates [ Time Frame: t=2 months ] [ Designated as safety issue: No ]
    Examined attendance rates in attending group sessions to examine attrition rates.
  • Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture [ Time Frame: t= 2 months ] [ Designated as safety issue: No ]
  • Fragmented Sleep Patterns-Sleep Efficiency [ Time Frame: t=2 months ] [ Designated as safety issue: No ]
    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.
  • Fragmented sleep patterns [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • hypnotic medication use [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • attrition rates [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
  • Veteran Satisfaction Scores [ Time Frame: 0,1,2 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Sleep Initiation and Maintenance Disorders
  • Other: True group auricular acupuncture
    Received true group auricular acupuncture
  • Other: Sham group auricular acupuncture
    Received sham auricular acupuncture.
  • Other: Wait-List Control Group
    Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
  • Experimental: True Group Auricular Acupuncture
    Received true group auricular acupuncture twice weekly for a period of two months.
    Intervention: Other: True group auricular acupuncture
  • Sham Comparator: Sham Group Auricular Acupuncture
    Received sham group auricular acupuncture twice weekly for a period of two months.
    Intervention: Other: Sham group auricular acupuncture
  • Wait-List Control Group
    Served as wait list control. Did not receive any acupuncture during the study period.
    Intervention: Other: Wait-List Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00868517
NRI 08-121
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Michelle K Prisco, MSN BC-ANP VA Medical Center, DC
Department of Veterans Affairs
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP