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

6 april 2015 uppdaterad av: US Department of Veterans Affairs

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

35

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20422
        • Washington DC VA Medical Center, Washington, DC

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Perceived Sleep Quality
Tidsram: 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.

t=2 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Tidsram: 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.
t=2 months
Hypnotic Medication Use
Tidsram: 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).
t=2 months
Attrition Rates
Tidsram: t=2 months
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
Tidsram: t= 2 months
t= 2 months
Fragmented Sleep Patterns-Sleep Efficiency
Tidsram: 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.
t=2 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Michelle Kennedy Prisco, MSN BC-ANP, Washington DC VA Medical Center, Washington, DC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2009

Primärt slutförande (Faktisk)

1 september 2011

Avslutad studie (Faktisk)

1 december 2011

Studieregistreringsdatum

Först inskickad

23 mars 2009

Först inskickad som uppfyllde QC-kriterierna

23 mars 2009

Första postat (Uppskatta)

25 mars 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 april 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 april 2015

Senast verifierad

1 september 2014

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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