An interventional study of True group auricular acupuncture and Sham group auricular acupuncture in Stress Disorders, Post-Traumatic and Sleep Initiation and Maintenance Disorders, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-28.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study also examined the degree of veteran acceptance for a group ear acupuncture procedure.
Background: Approximately 70-91% of veterans with Post-Traumatic Stress Disorder (PTSD) report insomnia. Presently, conventional treatments for PTSD-related insomnia include medications, psychotherapy, and cognitive behavioral therapy. While some of these conventional treatments do improve PTSD-related insomnia, many of these treatments have limitations (e.g., medication effects, lengthy time commitments, psycho-social stigma). Because of these limitations, many veterans are increasingly turning to complementary and alternative therapies to relieve their symptoms. There is a growing body of research that shows that acupuncture may improve many health symptoms including depression, PTSD, addiction, headaches, musculoskeletal pain, and insomnia. However, to date, no study has specifically explored how acupuncture may affect PTSD-related insomnia. Because so many veterans with PTSD experience PTSD-related insomnia, and because the current conflicts in Southwest Asia are producing a new generation of combat veterans, it is critical that the VA explore innovative treatments for PTSD-related health concerns.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's enrollment of 35 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Received true group auricular acupuncture twice weekly for a period of two months.
Other: True group auricular acupuncture
Received sham group auricular acupuncture twice weekly for a period of two months.
Other: Sham group auricular acupuncture
Served as wait list control. Did not receive any acupuncture during the study period.
Other: Wait-List Control Group
Received true group auricular acupuncture
Received sham auricular acupuncture.
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
Perceived Sleep Quality
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
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
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
Hypnotic Medication Use
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
Attrition Rates
Examined attendance rates in attending group sessions to examine attrition rates.
Time frame: t=2 months
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
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
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.
| Milestone | 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 |
| Withdrew: Withdrawal by subject | 3 | 3 | 2 |
| Withdrew: Protocol violation | 1 | 1 | 0 |
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.
| units on a scale | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group |
|---|---|---|---|
| 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) |
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.
| minutes | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group |
|---|---|---|---|
| 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) |
Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).
| participants | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group |
|---|---|---|---|
| Increased Hypnotic Medication Use | 0 | 1 | 0 |
| Decreased Hypnotic Medication Use | 1 | 0 | 0 |
| No Change | 2 | 3 | 3 |
| Not Applicable | 5 | 4 | 6 |
Examined attendance rates in attending group sessions to examine attrition rates.
| % of sessions attended | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group |
|---|---|---|---|
| Attrition Rates | 68.0 ± 17.5 | 60.2 ± 21.2 | — |
| participants | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group |
|---|---|---|---|
| Quality of Acupuncture (Very Good or Excellent) | 8 | 7 | — |
| Acupuncture addressed main health concern | 8 | 8 | — |
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.
| percentage of TST to time in bed | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group |
|---|---|---|---|
| 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) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| True Group Auricular Acupuncture | — | 0/12 (0%) | 0/12 (0%) |
| Sham Group Auricular Acupuncture | — | 0/12 (0%) | 1/12 (8.3%) |
| Wait List Control Group | — | 0/11 (0%) | 0/11 (0%) |
| Event | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group |
|---|---|---|---|
| Did not like acupuncture needlesSurgical and medical procedures | 0/12 | 1/12 | 0/11 |
OEF/OIF Veterans with PTSD-related insomnia.
| Age, Continuous(years) | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group | Total |
|---|---|---|---|---|
| Mean | 37.8 ± 11.4 | 37.9 ± 10.3 | 37.6 ± 8.0 | 37.8 ± 9.9 |
| Sex: Female, Male(Participants) | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group | Total |
|---|---|---|---|---|
| Female | 2 | 4 | 4 | 10 |
| Male | 10 | 8 | 7 | 25 |
| Race (NIH/OMB)(Participants) | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group | Total |
|---|---|---|---|---|
| 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)(units on a scale) | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group | Total |
|---|---|---|---|---|
| Mean | 55.1 ± 11.4 | 57.8 ± 10.3 | 60.5 ± 14.4 | 57.9 ± 12.0 |
| PTSD symptom duration(years) | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group | Total |
|---|---|---|---|---|
| Mean | 5.2 ± 3 | 6.3 ± 5.4 | 6.2 ± 3.2 | 5.9 ± 3.9 |
| PTSD-related insomnia duration(years) | True Group Auricular Acupuncture | Sham Group Auricular Acupuncture | Wait List Control Group | Total |
|---|---|---|---|---|
| Mean | 4.9 ± 3 | 6.2 ± 5.6 | 5.7 ± 3.4 | 5.6 ± 3.9 |
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Sleep Initiation and Maintenance Disorders→
US Department of Veterans Affairs