Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
The Effect of Acupuncture on PTSD-Related Insomnia
1 other identifier
interventional
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
November 17, 2014
CompletedApril 28, 2015
September 1, 2014
1.9 years
March 23, 2009
September 22, 2014
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perceived Sleep Quality
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
Secondary Outcomes (5)
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
t=2 months
Hypnotic Medication Use
t=2 months
Attrition Rates
t=2 months
Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
t= 2 months
Fragmented Sleep Patterns-Sleep Efficiency
t=2 months
Study Arms (3)
True Group Auricular Acupuncture
EXPERIMENTALReceived true group auricular acupuncture twice weekly for a period of two months.
Sham Group Auricular Acupuncture
SHAM COMPARATORReceived sham group auricular acupuncture twice weekly for a period of two months.
Wait-List Control Group
OTHERServed as wait list control. Did not receive any acupuncture during the study period.
Interventions
Received true group auricular acupuncture
Received sham auricular acupuncture.
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michelle Kennedy Prisco
- Organization
- Department of Veterans Affairs
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Kennedy Prisco, MSN BC-ANP
Washington DC VA Medical Center, Washington, DC
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 25, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
April 28, 2015
Results First Posted
November 17, 2014
Record last verified: 2014-09