NCT04031365

Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: United States Naval Medical Center, San Diego · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 members using reliable and valid measures.

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 Freedom and Operation Iraqi Freedom. Sleep disturbances (SDs) are important maintainers of PTSD symptoms in service members. Yet, they remain resistant to treatment for many service members. To mitigate the consequences of allostatic load, researchers have investigated the effects of acupuncture as a promising intervention. Objectives/Aims: The overall goal of this study is to evaluate the effectiveness and perceived benefits of a manual standardized acupuncture (MSSA) as an adjunct therapy to an abbreviated cognitive behavioral therapy (ACBT) in the treatment of SDs in post-deployment military service members. Specific aims include the following: a) To evaluate the effectiveness of MSSA as an adjunct treatment with ACBT, as compared to ACBT alone, for SDs using the Insomnia Severity Index (ISI) and Pittsburg Sleep Quality Index (PSQI) in post-deployment military service members, b) To describe the perceived benefit of MSSA as an adjunct treatment with ACBT, as compared with ACBT alone, for SDs using journal log entries in post-deployment military service members, and c) To explore the influence of participant expectation on the effectiveness of acupuncture on SDs using the Acupuncture Expectancy Scale (AES) in post-deployment military service members in the experimental group. Methods and Analysis: This is a two-arm, single-center randomized controlled trial in U.S. Naval Hospital, Okinawa, Japan. A random assignment process will be conducted by the primary investigator using permutated block randomization. Service members who meet the study selection criteria and decide to participate will be randomly assigned to either the experimental or control group: 1) Experimental: MSSA and ACBT, or 2) Control: ACBT only and waitlist for acupuncture. Patient-reported questionnaires including ISI, PSQI, and AES will be administered at baseline and then at the completion of the study. Descriptive statistics, reliable change indices, and mixed effects generalized linear models that correct standard errors for repeated assessments will be used to test for the interactive effect of acupuncture treatment and time in the study on each outcome controlling for respective baseline values. Military Relevance: Given the role of sleep disturbances in posttraumatic stress disorder in the military, intervening early before service members become at risk for severe injuries, hospitalizations, and chronic disability could help decrease burdensome problems.

Conditions

• Sleep Disturbance

Interventions

Type	Name	Description
PROCEDURE	Acupuncture	Use of sterile, disposable needles in acupuncture
BEHAVIORAL	Cognitive Behavioral Therapy	psychotherapy

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2019-07-24
• Last updated: 2020-09-10

Locations

1 site across 1 country: Japan