Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic
Conditions
Keywords
Veterans, Operation Iraqi Freedom, Operation Enduring Freedom, Combat Disorders, Acupuncture, Complementary Therapies
Brief summary
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.
Detailed description
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.
Interventions
OTHERTrue group auricular acupuncture
Received true group auricular acupuncture
OTHERSham group auricular acupuncture
Received sham auricular acupuncture.
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts; 2. Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria; 3. Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI); 4. Diagnosis of insomnia made after PTSD diagnosis; and 5. If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.
Exclusion criteria
1. Does not speak English; 2. Not competent to sign informed consent; 3. History of moderate or severe traumatic brain injury 4. Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study. 5. Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis; 6. History of substance abuse Dependence (as defined per DSM IV criteria) during the one year preceding enrollment in the study OR history of illicit substance use for 3 months prior to study enrollment OR positive Audit C score at study enrollment (defined as score of 5 and above). 7. Received acupuncture during past 3 months. 8. On Coumadin, Heparin, or Lovenox 9. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Sleep Quality | t=2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | t=2 months | 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. |
| Hypnotic Medication Use | t=2 months | Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD). |
| Attrition Rates | t=2 months | Examined attendance rates in attending group sessions to examine attrition rates. |
| 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 | t=2 months | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| True Group Auricular Acupuncture Received true group auricular acupuncture.
True group auricular acupuncture: Received true group auricular acupuncture | 12 |
| Sham Group Auricular Acupuncture Received sham group auricular acupuncture
Sham group auricular acupuncture: Received sham auricular acupuncture. | 12 |
| 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. | 11 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Wait List Control Group | Sham Group Auricular Acupuncture | True Group Auricular Acupuncture |
|---|---|---|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 9.9 | 37.6 years STANDARD_DEVIATION 8 | 37.9 years STANDARD_DEVIATION 10.3 | 37.8 years STANDARD_DEVIATION 11.4 |
| Post-Traumatic Stress Disorder Checklist-military version (PCL-M) | 57.9 units on a scale STANDARD_DEVIATION 12 | 60.5 units on a scale STANDARD_DEVIATION 14.4 | 57.8 units on a scale STANDARD_DEVIATION 10.3 | 55.1 units on a scale STANDARD_DEVIATION 11.4 |
| PTSD-related insomnia duration | 5.6 years STANDARD_DEVIATION 3.9 | 5.7 years STANDARD_DEVIATION 3.4 | 6.2 years STANDARD_DEVIATION 5.6 | 4.9 years STANDARD_DEVIATION 3 |
| PTSD symptom duration | 5.9 years STANDARD_DEVIATION 3.9 | 6.2 years STANDARD_DEVIATION 3.2 | 6.3 years STANDARD_DEVIATION 5.4 | 5.2 years STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 3 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 4 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 11 Participants | 4 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 25 Participants | 7 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 1 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 11 |
Outcome results
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.
Time frame: t=2 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| True Group Auricular Acupuncture | Perceived Sleep Quality | Morin Sleep Diary Refreshness rating | 2.8 units on a scale |
| True Group Auricular Acupuncture | Perceived Sleep Quality | Insomnia Severity Index total score | 16.3 units on a scale |
| True Group Auricular Acupuncture | Perceived Sleep Quality | Morin Sleep Diary Soundness Rating | 2.8 units on a scale |
| Sham Group Auricular Acupuncture | Perceived Sleep Quality | Morin Sleep Diary Soundness Rating | 2.8 units on a scale |
| Sham Group Auricular Acupuncture | Perceived Sleep Quality | Morin Sleep Diary Refreshness rating | 2.6 units on a scale |
| Sham Group Auricular Acupuncture | Perceived Sleep Quality | Insomnia Severity Index total score | 17.6 units on a scale |
| Wait List Control Group | Perceived Sleep Quality | Insomnia Severity Index total score | 20.1 units on a scale |
| Wait List Control Group | Perceived Sleep Quality | Morin Sleep Diary Refreshness rating | 2.3 units on a scale |
| Wait List Control Group | Perceived Sleep Quality | Morin Sleep Diary Soundness Rating | 2.4 units on a scale |
Secondary
Attrition Rates
Examined attendance rates in attending group sessions to examine attrition rates.
Time frame: t=2 months
Population: For this measure, participants in wait list control group not analyzed as did not participate in group sessions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| True Group Auricular Acupuncture | Attrition Rates | 68.0 % of sessions attended | Standard Deviation 17.5 |
| Sham Group Auricular Acupuncture | Attrition Rates | 60.2 % of sessions attended | Standard Deviation 21.2 |
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.
Time frame: t=2 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Sleep Efficiency | Sleep Efficiency (SE)-MSD | 77.3 percentage of TST to time in bed |
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Sleep Efficiency | Sleep Efficiency (SE)-WA | 77.9 percentage of TST to time in bed |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Sleep Efficiency | Sleep Efficiency (SE)-MSD | 81 percentage of TST to time in bed |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Sleep Efficiency | Sleep Efficiency (SE)-WA | 83.1 percentage of TST to time in bed |
| Wait List Control Group | Fragmented Sleep Patterns-Sleep Efficiency | Sleep Efficiency (SE)-MSD | 80.8 percentage of TST to time in bed |
| Wait List Control Group | Fragmented Sleep Patterns-Sleep Efficiency | Sleep Efficiency (SE)-WA | 79.7 percentage of TST to time in bed |
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.
Time frame: t=2 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Sleep Latency (SL)-MSD | 26.6 minutes |
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Sleep Latency (SL)-WA | 22.6 minutes |
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Total Sleep Time (TST)-WA | 344.3 minutes |
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Total Sleep Time (TST)-MSD | 303.8 minutes |
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Naps-WA | 33.9 minutes |
| True Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Naps-MSD | 66.4 minutes |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Total Sleep Time (TST)-WA | 407.6 minutes |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Sleep Latency (SL)-MSD | 31 minutes |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Naps-MSD | 16.9 minutes |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Total Sleep Time (TST)-MSD | 397.3 minutes |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Sleep Latency (SL)-WA | 34.1 minutes |
| Sham Group Auricular Acupuncture | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Naps-WA | 16.6 minutes |
| Wait List Control Group | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Naps-WA | 33.9 minutes |
| Wait List Control Group | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Sleep Latency (SL)-WA | 37 minutes |
| Wait List Control Group | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Sleep Latency (SL)-MSD | 34.4 minutes |
| Wait List Control Group | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Total Sleep Time (TST)-MSD | 378.8 minutes |
| Wait List Control Group | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Total Sleep Time (TST)-WA | 369.0 minutes |
| Wait List Control Group | Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps | Naps-MSD | 15.9 minutes |
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).
Time frame: t=2 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| True Group Auricular Acupuncture | Hypnotic Medication Use | Increased Hypnotic Medication Use | 0 participants |
| True Group Auricular Acupuncture | Hypnotic Medication Use | Decreased Hypnotic Medication Use | 1 participants |
| True Group Auricular Acupuncture | Hypnotic Medication Use | No Change | 2 participants |
| True Group Auricular Acupuncture | Hypnotic Medication Use | Not Applicable | 5 participants |
| Sham Group Auricular Acupuncture | Hypnotic Medication Use | Not Applicable | 4 participants |
| Sham Group Auricular Acupuncture | Hypnotic Medication Use | Increased Hypnotic Medication Use | 1 participants |
| Sham Group Auricular Acupuncture | Hypnotic Medication Use | No Change | 3 participants |
| Sham Group Auricular Acupuncture | Hypnotic Medication Use | Decreased Hypnotic Medication Use | 0 participants |
| Wait List Control Group | Hypnotic Medication Use | Not Applicable | 6 participants |
| Wait List Control Group | Hypnotic Medication Use | Decreased Hypnotic Medication Use | 0 participants |
| Wait List Control Group | Hypnotic Medication Use | No Change | 3 participants |
| Wait List Control Group | Hypnotic Medication Use | Increased Hypnotic Medication Use | 0 participants |
Secondary
Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
Time frame: t= 2 months
Population: For this measure, participants in wait list control group not analyzed as did not participate in group sessions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| True Group Auricular Acupuncture | 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 |
| True Group Auricular Acupuncture | 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 |
| Sham Group Auricular Acupuncture | 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) | 7 participants |
| Sham Group Auricular Acupuncture | 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 |