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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True Group Auricular Acupuncture | Experimental | Received true group auricular acupuncture twice weekly for a period of two months. |
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| Sham Group Auricular Acupuncture | Sham Comparator | Received sham group auricular acupuncture twice weekly for a period of two months. |
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| Wait-List Control Group | Other | Served as wait list control. Did not receive any acupuncture during the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| True group auricular acupuncture | Other | Received true group auricular acupuncture |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | t=2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | t=2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Kennedy Prisco, MSN BC-ANP | Washington DC VA Medical Center, Washington, DC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington DC VA Medical Center, Washington, DC | Washington D.C. | District of Columbia | 20422 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | True Group Auricular Acupuncture | Received true group auricular acupuncture. |
| FG001 | Sham Group Auricular Acupuncture | Received sham group auricular acupuncture. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sham group auricular acupuncture | Other | Received sham auricular acupuncture. |
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| Wait-List Control Group | Other | Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed. |
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| 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). | t=2 months |
| Attrition Rates | Examined attendance rates in attending group sessions to examine attrition rates. | t=2 months |
| Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture | 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. | t=2 months |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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OEF/OIF Veterans with PTSD-related insomnia.
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| ID | Title | Description |
|---|---|---|
| BG000 | True Group Auricular Acupuncture | Received true group auricular acupuncture. True group auricular acupuncture: Received true group auricular acupuncture |
| BG001 | Sham Group Auricular Acupuncture | Received sham group auricular acupuncture Sham group auricular acupuncture: Received sham auricular acupuncture. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Post-Traumatic Stress Disorder Checklist-military version (PCL-M) | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| PTSD symptom duration | Mean | Standard Deviation | years |
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| PTSD-related insomnia duration | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | t=2 months |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | minutes | t=2 months |
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| Secondary | 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). | Posted | Number | participants | t=2 months |
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| Secondary | Attrition Rates | Examined attendance rates in attending group sessions to examine attrition rates. | For this measure, participants in wait list control group not analyzed as did not participate in group sessions. | Posted | Mean | Standard Deviation | % of sessions attended | t=2 months |
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| Secondary | Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture | For this measure, participants in wait list control group not analyzed as did not participate in group sessions. | Posted | Number | participants | t= 2 months |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage of TST to time in bed | t=2 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | True Group Auricular Acupuncture | Received true group auricular acupuncture. True group auricular acupuncture: Received true group auricular acupuncture | 0 | 12 | 0 | 12 | ||
| EG001 | Sham Group Auricular Acupuncture | Received sham group auricular acupuncture Sham group auricular acupuncture: Received sham auricular acupuncture. | 0 | 12 | 1 | 12 | ||
| EG002 | 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. | 0 | 11 | 0 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Did not like acupuncture needles | Surgical and medical procedures | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Kennedy Prisco | Department of Veterans Affairs | 202-745-8000 | 56235 | michelle.prisco@va.gov |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Insomnia Severity Index total score |
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