Status:
COMPLETED
Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members
Lead Sponsor:
United States Naval Medical Center, San Diego
Conditions:
Sleep Disturbance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This randomized study will evaluate the effect of a brief acupuncture therapy in addition to a brief cognitive behavioral therapy in mitigating sleep disturbances in post-deployment military service m...
Detailed Description
Introduction: Sleep disturbance is a hallmark symptom of posttraumatic stress disorder (PTSD) and an important antecedent in PTSD recovery in service members who were deployed to Operation Enduring Fr...
Eligibility Criteria
Inclusion
- 18 to 65 years of age who have been deployed to operational environments (combat zones, ship deployments, or other austere environments),
- Self-report of deployment experience and SD symptoms for at least one month,
- A score of 15 or above on the Insomnia Severity Index (ISI)(C. Morin et al., 2011),
- A score of 5 or more on the Pittsburg Sleep Quality Index (PSQI)(Buysse et al., 1988),
- Stable on psychiatric and other medications including blood pressure agents for at least three months,
- Agrees to participate in a group psychotherapy,
- Agrees to conduct individual interview via the telephone,
- Agrees to abstain from sedative-hypnotics and sleep aids including over-the-counter drugs throughout the study (i.e., five weeks), and
- Able to sign an informed consent.
Exclusion
- Surgery within one month,
- Substance use disorder diagnosis within one month,
- Substance use disorder treatment within one month,
- Pregnant women (acupuncture can result in an induction of labor and spontaneous abortion in rare occasions (White et al., 2008),
- Has had acupuncture treatment or dry needling (i.e., physical therapy intervention typically utilized for musculoskeletal pain complaints) in the past month,
- Has had psychotherapy within one month, and
- Previous diagnosis of other sleep disorders or medical conditions that could impact sleep (e.g., obstructive sleep apnea).
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04031365
Start Date
October 14 2019
End Date
April 30 2020
Last Update
September 10 2020
Active Locations (1)
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1
U.S. Naval Hospital Okinawa
Okinawa, Japan