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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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
Enrollment 35
Recruitment Details 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 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.
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait-List Control Group
Hide Arm/Group Description Received true group auricular acupuncture. Received sham group auricular acupuncture. 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.
Period Title: Overall Study
Started 12 12 11
Completed 8 8 9
Not Completed 4 4 2
Reason Not Completed
Withdrawal by Subject             3             3             2
Protocol Violation             1             1             0
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group Total
Hide Arm/Group Description

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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 of all reporting groups
Overall Number of Baseline Participants 12 12 11 35
Hide Baseline Analysis Population Description
OEF/OIF Veterans with PTSD-related insomnia.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 11 participants 35 participants
37.8  (11.4) 37.9  (10.3) 37.6  (8.0) 37.8  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 11 participants 35 participants
Female
2
  16.7%
4
  33.3%
4
  36.4%
10
  28.6%
Male
10
  83.3%
8
  66.7%
7
  63.6%
25
  71.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 11 participants 35 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  41.7%
4
  33.3%
3
  27.3%
12
  34.3%
White
4
  33.3%
3
  25.0%
4
  36.4%
11
  31.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  25.0%
5
  41.7%
4
  36.4%
12
  34.3%
Post-Traumatic Stress Disorder Checklist-military version (PCL-M)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 12 participants 11 participants 35 participants
55.1  (11.4) 57.8  (10.3) 60.5  (14.4) 57.9  (12.0)
[1]
Measure Description: 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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 11 participants 35 participants
5.2  (3) 6.3  (5.4) 6.2  (3.2) 5.9  (3.9)
PTSD-related insomnia duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 11 participants 35 participants
4.9  (3) 6.2  (5.6) 5.7  (3.4) 5.6  (3.9)
1.Primary Outcome
Title Perceived Sleep Quality
Hide Description

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.

Time Frame t=2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Hide Arm/Group Description:

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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.

Overall Number of Participants Analyzed 8 8 9
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Morin Sleep Diary Refreshness rating
2.8
(2.1 to 3.4)
2.6
(2.0 to 3.2)
2.3
(1.8 to 2.9)
Morin Sleep Diary Soundness Rating
2.8
(2.1 to 3.4)
2.8
(2.1 to 3.4)
2.4
(1.8 to 3.1)
Insomnia Severity Index total score
16.3
(12.1 to 20.4)
17.6
(13.5 to 21.7)
20.1
(16.2 to 24)
2.Secondary Outcome
Title Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Hide Description 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.
Time Frame t=2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Hide Arm/Group Description:

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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.

Overall Number of Participants Analyzed 8 8 9
Mean (95% Confidence Interval)
Unit of Measure: minutes
Total Sleep Time (TST)-MSD
303.8
(242.8 to 364.7)
397.3
(336.3 to 458.2)
378.8
(321.3 to 436.2)
Sleep Latency (SL)-MSD
26.6
(6.4 to 46.9)
31
(10.8 to 51.2)
34.4
(15.4 to 53.5)
Naps-MSD
66.4
(31.9 to 100.9)
16.9
(-17.6 to 51.4)
15.9
(-16.7 to 48.4)
Total Sleep Time (TST)-WA
344.3
(288.3 to 400.2)
407.6
(355.3 to 460.0)
369.0
(316.7 to 421.3)
Sleep Latency (SL)-WA
22.6
(-2.5 to 47.6)
34.1
(10.7 to 57.6)
37
(13.6 to 60.4)
Naps-WA
33.9
(13.7 to 54)
16.6
(-3.5 to 36.8)
33.9
(13.7 to 54.0)
3.Secondary Outcome
Title Hypnotic Medication Use
Hide Description Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).
Time Frame t=2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Hide Arm/Group Description:

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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.

Overall Number of Participants Analyzed 8 8 9
Measure Type: Number
Unit of Measure: participants
Increased Hypnotic Medication Use 0 1 0
Decreased Hypnotic Medication Use 1 0 0
No Change 2 3 3
Not Applicable 5 4 6
4.Secondary Outcome
Title Attrition Rates
Hide Description Examined attendance rates in attending group sessions to examine attrition rates.
Time Frame t=2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this measure, participants in wait list control group not analyzed as did not participate in group sessions.
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Hide Arm/Group Description:

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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.

Overall Number of Participants Analyzed 8 8 0
Mean (Standard Deviation)
Unit of Measure: % of sessions attended
68.0  (17.5) 60.2  (21.2)
5.Secondary Outcome
Title Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
Hide Description [Not Specified]
Time Frame t= 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this measure, participants in wait list control group not analyzed as did not participate in group sessions.
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Hide Arm/Group Description:

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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.

Overall Number of Participants Analyzed 8 8 0
Measure Type: Number
Unit of Measure: participants
Quality of Acupuncture (Very Good or Excellent) 8 7
Acupuncture addressed main health concern 8 8
6.Secondary Outcome
Title Fragmented Sleep Patterns-Sleep Efficiency
Hide Description 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.
Time Frame t=2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Hide Arm/Group Description:

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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.

Overall Number of Participants Analyzed 8 8 9
Mean (95% Confidence Interval)
Unit of Measure: percentage of TST to time in bed
Sleep Efficiency (SE)-MSD
77.3
(69.2 to 85.4)
81
(72.9 to 89.1)
80.8
(73.2 to 88.4)
Sleep Efficiency (SE)-WA
77.9
(70.4 to 85.3)
83.1
(76.1 to 90)
79.7
(72.7 to 86.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Hide Arm/Group Description

Received true group auricular acupuncture.

True group auricular acupuncture: Received true group auricular acupuncture

Received sham group auricular acupuncture

Sham group auricular acupuncture: Received sham auricular acupuncture.

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.

All-Cause Mortality
True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
True Group Auricular Acupuncture Sham Group Auricular Acupuncture Wait List Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      1/12 (8.33%)      0/11 (0.00%)    
Surgical and medical procedures       
Did not like acupuncture needles [1]  0/12 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0
[1]
One participant in the sham auricular acupuncture group felt that the acupuncture needling was uncomfortable and as a result, did not wish to participate in study. The acupuncture needles were removed and no residual health effects were reported.
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 ( US Department of Veterans Affairs )
ClinicalTrials.gov 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