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Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
The Effect of Acupuncture on PTSD-Related Insomnia
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20422
- Washington DC VA Medical Center, Washington, DC
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: True Group Auricular Acupuncture
Received true group auricular acupuncture twice weekly for a period of two months.
|
Received true group auricular acupuncture
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Sham-vergelijker: Sham Group Auricular Acupuncture
Received sham group auricular acupuncture twice weekly for a period of two months.
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Received sham auricular acupuncture.
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Ander: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Perceived Sleep Quality
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: t=2 months
|
Examined attendance rates in attending group sessions to examine attrition rates.
|
t=2 months
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Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
Tijdsspanne: t= 2 months
|
t= 2 months
|
|
Fragmented Sleep Patterns-Sleep Efficiency
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Michelle Kennedy Prisco, MSN BC-ANP, Washington DC VA Medical Center, Washington, DC
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NRI 08-121
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