Trial Outcomes & Findings for Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder (NCT NCT00868517)
NCT ID: NCT00868517
Last Updated: 2015-04-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
t=2 months
Results posted on
2015-04-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
11
|
|
Overall Study
COMPLETED
|
8
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
Baseline Characteristics
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
True Group Auricular Acupuncture
n=12 Participants
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=12 Participants
Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture.
|
Wait List Control Group
n=11 Participants
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
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Post-Traumatic Stress Disorder Checklist-military version (PCL-M)
|
55.1 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
57.8 units on a scale
STANDARD_DEVIATION 10.3 • n=7 Participants
|
60.5 units on a scale
STANDARD_DEVIATION 14.4 • n=5 Participants
|
57.9 units on a scale
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
PTSD symptom duration
|
5.2 years
STANDARD_DEVIATION 3 • n=5 Participants
|
6.3 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
6.2 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
|
PTSD-related insomnia duration
|
4.9 years
STANDARD_DEVIATION 3 • n=5 Participants
|
6.2 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
5.7 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
5.6 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: t=2 monthsPerceived 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.
Outcome measures
| Measure |
True Group Auricular Acupuncture
n=8 Participants
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=8 Participants
Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture.
|
Wait List Control Group
n=9 Participants
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.
|
|---|---|---|---|
|
Perceived Sleep Quality
Morin Sleep Diary Refreshness rating
|
2.8 units on a scale
Interval 2.1 to 3.4
|
2.6 units on a scale
Interval 2.0 to 3.2
|
2.3 units on a scale
Interval 1.8 to 2.9
|
|
Perceived Sleep Quality
Morin Sleep Diary Soundness Rating
|
2.8 units on a scale
Interval 2.1 to 3.4
|
2.8 units on a scale
Interval 2.1 to 3.4
|
2.4 units on a scale
Interval 1.8 to 3.1
|
|
Perceived Sleep Quality
Insomnia Severity Index total score
|
16.3 units on a scale
Interval 12.1 to 20.4
|
17.6 units on a scale
Interval 13.5 to 21.7
|
20.1 units on a scale
Interval 16.2 to 24.0
|
SECONDARY outcome
Timeframe: t=2 monthsDisruptive 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.
Outcome measures
| Measure |
True Group Auricular Acupuncture
n=8 Participants
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=8 Participants
Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture.
|
Wait List Control Group
n=9 Participants
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.
|
|---|---|---|---|
|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Total Sleep Time (TST)-MSD
|
303.8 minutes
Interval 242.8 to 364.7
|
397.3 minutes
Interval 336.3 to 458.2
|
378.8 minutes
Interval 321.3 to 436.2
|
|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Sleep Latency (SL)-MSD
|
26.6 minutes
Interval 6.4 to 46.9
|
31 minutes
Interval 10.8 to 51.2
|
34.4 minutes
Interval 15.4 to 53.5
|
|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Naps-MSD
|
66.4 minutes
Interval 31.9 to 100.9
|
16.9 minutes
Interval -17.6 to 51.4
|
15.9 minutes
Interval -16.7 to 48.4
|
|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Total Sleep Time (TST)-WA
|
344.3 minutes
Interval 288.3 to 400.2
|
407.6 minutes
Interval 355.3 to 460.0
|
369.0 minutes
Interval 316.7 to 421.3
|
|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Sleep Latency (SL)-WA
|
22.6 minutes
Interval -2.5 to 47.6
|
34.1 minutes
Interval 10.7 to 57.6
|
37 minutes
Interval 13.6 to 60.4
|
|
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Naps-WA
|
33.9 minutes
Interval 13.7 to 54.0
|
16.6 minutes
Interval -3.5 to 36.8
|
33.9 minutes
Interval 13.7 to 54.0
|
SECONDARY outcome
Timeframe: t=2 monthsAmount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).
Outcome measures
| Measure |
True Group Auricular Acupuncture
n=8 Participants
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=8 Participants
Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture.
|
Wait List Control Group
n=9 Participants
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.
|
|---|---|---|---|
|
Hypnotic Medication Use
Increased Hypnotic Medication Use
|
0 participants
|
1 participants
|
0 participants
|
|
Hypnotic Medication Use
Decreased Hypnotic Medication Use
|
1 participants
|
0 participants
|
0 participants
|
|
Hypnotic Medication Use
No Change
|
2 participants
|
3 participants
|
3 participants
|
|
Hypnotic Medication Use
Not Applicable
|
5 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: t=2 monthsPopulation: For this measure, participants in wait list control group not analyzed as did not participate in group sessions.
Examined attendance rates in attending group sessions to examine attrition rates.
Outcome measures
| Measure |
True Group Auricular Acupuncture
n=8 Participants
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=8 Participants
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.
|
|---|---|---|---|
|
Attrition Rates
|
68.0 % of sessions attended
Standard Deviation 17.5
|
60.2 % of sessions attended
Standard Deviation 21.2
|
—
|
SECONDARY outcome
Timeframe: t= 2 monthsPopulation: For this measure, participants in wait list control group not analyzed as did not participate in group sessions.
Outcome measures
| Measure |
True Group Auricular Acupuncture
n=8 Participants
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=8 Participants
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.
|
|---|---|---|---|
|
Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
Quality of Acupuncture (Very Good or Excellent)
|
8 participants
|
7 participants
|
—
|
|
Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
Acupuncture addressed main health concern
|
8 participants
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: t=2 monthsDisruptive 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.
Outcome measures
| Measure |
True Group Auricular Acupuncture
n=8 Participants
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=8 Participants
Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture.
|
Wait List Control Group
n=9 Participants
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.
|
|---|---|---|---|
|
Fragmented Sleep Patterns-Sleep Efficiency
Sleep Efficiency (SE)-MSD
|
77.3 percentage of TST to time in bed
Interval 69.2 to 85.4
|
81 percentage of TST to time in bed
Interval 72.9 to 89.1
|
80.8 percentage of TST to time in bed
Interval 73.2 to 88.4
|
|
Fragmented Sleep Patterns-Sleep Efficiency
Sleep Efficiency (SE)-WA
|
77.9 percentage of TST to time in bed
Interval 70.4 to 85.3
|
83.1 percentage of TST to time in bed
Interval 76.1 to 90.0
|
79.7 percentage of TST to time in bed
Interval 72.7 to 86.7
|
Adverse Events
True Group Auricular Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Group Auricular Acupuncture
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Wait List Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
True Group Auricular Acupuncture
n=12 participants at risk
Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture
|
Sham Group Auricular Acupuncture
n=12 participants at risk
Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture.
|
Wait List Control Group
n=11 participants at risk
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.
|
|---|---|---|---|
|
Surgical and medical procedures
Did not like acupuncture needles
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place