Stress Disorders, Post-TraumaticNCT00868517
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
A study testing True group auricular acupuncture in people with Stress Disorders, Post-Traumatic and Sleep Initiation and Maintenance Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
- What is being tested?
- True group auricular acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
- Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
- Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
- Diagnosis of insomnia made after PTSD diagnosis; and
- If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.
Who cannot join
- Does not speak English;
- Not competent to sign informed consent;
- History of moderate or severe traumatic brain injury
- Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
- Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
- 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).
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- Received acupuncture during past 3 months.
- On Coumadin, Heparin, or Lovenox
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: The Effect of Acupuncture on PTSD-Related Insomnia
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.
Read the 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.
- Being tested
- True group auricular acupuncture, Sham group auricular acupuncture, Wait-List Control Group
- Keywords
- Veterans, Operation Iraqi Freedom, Operation Enduring Freedom, Combat Disorders, Acupuncture, Complementary Therapies
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True group auricular acupunctureOther
Received true group auricular acupuncture
Sham group auricular acupunctureOther
Received sham auricular acupuncture.
Wait-List Control GroupOther
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
| Study group | Role | What they receive |
|---|---|---|
| True Group Auricular Acupuncture | Experimental | Received true group auricular acupuncture twice weekly for a period of two months. Receives: Other: True group auricular acupuncture |
| Sham Group Auricular Acupuncture | Sham comparator | Received sham group auricular acupuncture twice weekly for a period of two months. Receives: Other: Sham group auricular acupuncture |
| Wait-List Control Group | Other | Served as wait list control. Did not receive any acupuncture during the study period. Receives: Other: Wait-List Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: t=2 months
Secondary outcomes (5)
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.
Measured: 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).
Measured: t=2 months
Attrition Rates
Examined attendance rates in attending group sessions to examine attrition rates.
Measured: t=2 months
Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
Measured: 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.
Measured: t=2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michelle Kennedy Prisco, MSN BC-ANP, Principal investigator, Washington DC VA Medical Center, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868517
- Sponsor's protocol ID
- NRI 08-121
- Status last verified
- Sep 2014
- First submitted
- 23 Mar 2009
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on PTSD-Related Insomnia
- ClinicalTrials.gov ID
- NCT00868517
- Acronym / sponsor ID
- NRI 08-121
- Keywords
- Veterans, Operation Iraqi Freedom, Operation Enduring Freedom, Combat Disorders, Acupuncture, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Posted 17 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True Group Auricular Acupuncture | Experimental | Other: True group auricular acupunctureReceived true group auricular acupuncture twice weekly for a period of two months. |
| Sham Group Auricular Acupuncture | Sham comparator | Other: Sham group auricular acupunctureReceived sham group auricular acupuncture twice weekly for a period of two months. |
| Wait-List Control Group | Other | Other: Wait-List Control GroupServed as wait list control. Did not receive any acupuncture during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
- Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
- Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
- Diagnosis of insomnia made after PTSD diagnosis; and
- If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.
Key exclusion criteria (9 listed)
- Does not speak English;
- Not competent to sign informed consent;
- History of moderate or severe traumatic brain injury
- Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
- Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True group auricular acupunctureReceived true group auricular acupuncture | Other | True Group Auricular Acupuncture |
| Sham group auricular acupunctureReceived sham auricular acupuncture. | Other | Sham Group Auricular Acupuncture |
| Wait-List Control GroupReceived conventional care only. Eligible to receive true group auricular acupuncture once study period completed. | Other | Wait-List Control Group |
Primary outcome
Perceived Sleep Quality
Time frame: 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.
5 secondary outcomes
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Time frame: t=2 months
Hypnotic Medication Use
Time frame: t=2 months
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
Time frame: t=2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Kennedy Prisco, MSN BC-ANP principal investigator
Washington DC VA Medical Center, Washington, DC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True group auricular acupuncture in people with Stress Disorders, Post-Traumatic and Sleep Initiation and Maintenance Disorders, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Sleep Quality (time frame: t=2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.