Back to resultsExamining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
Primary Purpose
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
True group auricular acupuncture
Sham group auricular acupuncture
Wait-List Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Veterans, Operation Iraqi Freedom, Operation Enduring Freedom, Combat Disorders, Acupuncture, Complementary Therapies
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Received acupuncture during past 3 months.
- On Coumadin, Heparin, or Lovenox
- Pregnancy
Sites / Locations
- Washington DC VA Medical Center, Washington, DC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
True Group Auricular Acupuncture
Sham Group Auricular Acupuncture
Wait-List Control Group
Arm Description
Received true group auricular acupuncture twice weekly for a period of two months.
Received sham group auricular acupuncture twice weekly for a period of two months.
Served as wait list control. Did not receive any acupuncture during the study period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Attrition Rates
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
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.
Full Information
NCT ID
NCT00868517
First Posted
March 23, 2009
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00868517
Brief Title
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
Official Title
The Effect of Acupuncture on PTSD-Related Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Keywords
Veterans, Operation Iraqi Freedom, Operation Enduring Freedom, Combat Disorders, Acupuncture, Complementary Therapies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
True Group Auricular Acupuncture
Arm Type
Experimental
Arm Description
Received true group auricular acupuncture twice weekly for a period of two months.
Arm Title
Sham Group Auricular Acupuncture
Arm Type
Sham Comparator
Arm Description
Received sham group auricular acupuncture twice weekly for a period of two months.
Arm Title
Wait-List Control Group
Arm Type
Other
Arm Description
Served as wait list control. Did not receive any acupuncture during the study period.
Intervention Type
Other
Intervention Name(s)
True group auricular acupuncture
Intervention Description
Received true group auricular acupuncture
Intervention Type
Other
Intervention Name(s)
Sham group auricular acupuncture
Intervention Description
Received sham auricular acupuncture.
Intervention Type
Other
Intervention Name(s)
Wait-List Control Group
Intervention Description
Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed.
Primary Outcome Measure Information:
Title
Perceived Sleep Quality
Description
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
Secondary Outcome Measure Information:
Title
Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps
Description
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
Title
Hypnotic Medication Use
Description
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
Title
Attrition Rates
Description
Examined attendance rates in attending group sessions to examine attrition rates.
Time Frame
t=2 months
Title
Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture
Time Frame
t= 2 months
Title
Fragmented Sleep Patterns-Sleep Efficiency
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Received acupuncture during past 3 months.
On Coumadin, Heparin, or Lovenox
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Kennedy Prisco, MSN BC-ANP
Organizational Affiliation
Washington DC VA Medical Center, Washington, DC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington DC VA Medical Center, Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
12. IPD Sharing Statement
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Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
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