- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00868517
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
The Effect of Acupuncture on PTSD-Related Insomnia
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20422
- Washington DC VA Medical Center, Washington, DC
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
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
Utredare
- Huvudutredare: Michelle Kennedy Prisco, MSN BC-ANP, Washington DC VA Medical Center, Washington, DC
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NRI 08-121
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