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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868517
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : November 17, 2014
Last Update Posted : April 28, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single;   Primary Purpose: Treatment
Conditions: Stress Disorders, Post-Traumatic
Sleep Initiation and Maintenance Disorders
Interventions: Other: True group auricular acupuncture
Other: Sham group auricular acupuncture
Other: Wait-List Control Group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Letter, study flyers, and web sites were used to recruit Veterans to participate in this study at the Washington DC VA Medical Center. Veterans were recruited from November 2009 through June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Veterans who met initial telephone screening requirements were asked to participate in the full screening process. Of the 70 Veterans who provided informed consent, 35 Veterans were not randomized to study group because 1) did not meet full screening eligibility criteria; 2) did not complete baseline questionnaires; or 3) no longer eligible.

Reporting Groups
True Group Auricular Acupuncture Received true group auricular acupuncture.
Sham Group Auricular Acupuncture Received sham group auricular acupuncture.
Wait-List Control Group Served as wait-list control group. Did not receive any type of group ear acupuncture intervention--served as strict control and received conventional care only. Eligible to receive true group auricular acupuncture once study period was completed.

Participant Flow:   Overall Study
    True Group Auricular Acupuncture   Sham Group Auricular Acupuncture   Wait-List Control Group
STARTED   12   12   11 
COMPLETED   8   8   9 
NOT COMPLETED   4   4   2 
Withdrawal by Subject                3                3                2 
Protocol Violation                1                1                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
OEF/OIF Veterans with PTSD-related insomnia.

Reporting Groups
True Group Auricular Acupuncture

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Sham Group Auricular Acupuncture

Received sham group auricular acupuncture

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.

Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.

Total Total of all reporting groups

Baseline Measures
   True Group Auricular Acupuncture   Sham Group Auricular Acupuncture   Wait List Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   11   35 
[Units: Years]
Mean (Standard Deviation)
 37.8  (11.4)   37.9  (10.3)   37.6  (8.0)   37.8  (9.9) 
[Units: Participants]
Female   2   4   4   10 
Male   10   8   7   25 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   5   4   3   12 
White   4   3   4   11 
More than one race   0   0   0   0 
Unknown or Not Reported   3   5   4   12 
Post-Traumatic Stress Disorder Checklist-military version (PCL-M) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 55.1  (11.4)   57.8  (10.3)   60.5  (14.4)   57.9  (12.0) 
[1] The Post-Traumatic Stress Disorder Checklist-military version (PCL-M) is a widely used, 17-item self-report measure of the 17 DSM-IV symptoms of PTSD. Items are rated on a 5-point Likert scale, and the total score (range 17-85) is obtained by summing the scores from each of the 17 items. Total scores of the PCL-M were reported, and higher scores indicate higher degrees of PTSD symptoms.
PTSD symptom duration 
[Units: Years]
Mean (Standard Deviation)
 5.2  (3)   6.3  (5.4)   6.2  (3.2)   5.9  (3.9) 
PTSD-related insomnia duration 
[Units: Years]
Mean (Standard Deviation)
 4.9  (3)   6.2  (5.6)   5.7  (3.4)   5.6  (3.9) 

  Outcome Measures

1.  Primary:   Perceived Sleep Quality   [ Time Frame: t=2 months ]

2.  Secondary:   Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps   [ Time Frame: t=2 months ]

3.  Secondary:   Hypnotic Medication Use   [ Time Frame: t=2 months ]

4.  Secondary:   Attrition Rates   [ Time Frame: t=2 months ]

5.  Secondary:   Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture   [ Time Frame: t= 2 months ]

6.  Secondary:   Fragmented Sleep Patterns-Sleep Efficiency   [ Time Frame: t=2 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Michelle Kennedy Prisco
Organization: Department of Veterans Affairs
phone: 202-745-8000 ext 56235

Responsible Party: VA Office of Research and Development Identifier: NCT00868517     History of Changes
Other Study ID Numbers: NRI 08-121
First Submitted: March 23, 2009
First Posted: March 25, 2009
Results First Submitted: September 22, 2014
Results First Posted: November 17, 2014
Last Update Posted: April 28, 2015