Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT00868517|
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : November 17, 2014
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Sleep Initiation and Maintenance Disorders||Other: True group auricular acupuncture Other: Sham group auricular acupuncture Other: Wait-List Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Acupuncture on PTSD-Related Insomnia|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
Experimental: True Group Auricular Acupuncture
Received true group auricular acupuncture twice weekly for a period of two months.
Other: True group auricular acupuncture
Received true group auricular acupuncture
Sham Comparator: Sham Group Auricular Acupuncture
Received sham group auricular acupuncture twice weekly for a period of two months.
Other: Sham group auricular acupuncture
Received sham auricular acupuncture.
Wait-List Control Group
Served as wait list control. Did not receive any acupuncture during the study period.
Other: Wait-List Control Group
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
- Perceived Sleep Quality [ Time Frame: 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.
- Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps [ Time Frame: 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.
- Hypnotic Medication Use [ Time Frame: 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).
- Attrition Rates [ Time Frame: t=2 months ]Examined attendance rates in attending group sessions to examine attrition rates.
- Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture [ Time Frame: t= 2 months ]
- Fragmented Sleep Patterns-Sleep Efficiency [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868517
|United States, District of Columbia|
|Washington DC VA Medical Center, Washington, DC|
|Washington, District of Columbia, United States, 20422|
|Principal Investigator:||Michelle Kennedy Prisco, MSN BC-ANP||Washington DC VA Medical Center, Washington, DC|