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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00868517
First received: March 23, 2009
Last updated: November 6, 2014
Last verified: November 2014
Results First Received: September 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   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
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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
  Description
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
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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
  Description
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  
Number of Participants  
[units: participants]
  12     12     11     35  
Age  
[units: years]
Mean ± Standard Deviation
  37.8  ± 11.4     37.9  ± 10.3     37.6  ± 8.0     37.8  ± 9.9  
Gender  
[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  
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  
[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.



  Outcome Measures
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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:   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
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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
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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
e-mail: michelle.prisco@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00868517     History of Changes
Other Study ID Numbers: NRI 08-121
Study First Received: March 23, 2009
Results First Received: September 22, 2014
Last Updated: November 6, 2014
Health Authority: United States: Federal Government