Clinical trial NCT04031365: Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members
Official title: Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2019-07-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. 18 to 65 years of age who have been deployed to operational environments (combat zones, ship deployments, or other austere environments),
2. Self-report of deployment experience and SD symptoms for at least one month,
3. A score of 15 or above on the Insomnia Severity Index (ISI)(C. Morin et al., 2011),
4. A score of 5 or more on the Pittsburg Sleep Quality Index (PSQI)(Buysse et al., 1988),
5. Stable on psychiatric and other medications including blood pressure agents for at least three months,
6. Agrees to participate in a group psychotherapy,
7. Agrees to conduct individual interview via the telephone,
8. Agrees to abstain from sedative-hypnotics and sleep aids including over-the-counter drugs throughout the study (i.e., five weeks), and
9. Able to sign an informed consent.

Exclusion Criteria:

1. Surgery within one month,
2. Substance use disorder diagnosis within one month,
3. Substance use disorder treatment within one month,
4. Pregnant women (acupuncture can result in an induction of labor and spontaneous abortion in rare occasions (White et al., 2008),
5. Has had acupuncture treatment or dry needling (i.e., physical therapy intervention typically utilized for musculoskeletal pain complaints) in the past month,
6. Has had psychotherapy within one month, and
7. Previous diagnosis of other sleep disorders or medical conditions that could impact sleep (e.g., obstructive sleep apnea).

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 5 weeks
measure: Pittsburg Sleep Quality Index
timeFrame: 5 weeks
Secondary outcomes:
measure: Acupuncture Expectancy Scale
timeFrame: 5 weeks
Other outcomes:
measure: Posttraumatic Stress Disorder Checklist
timeFrame: 5 weeks
Locations:
city: Okinawa
country: Japan
facility: U.S. Naval Hospital Okinawa
Study officials:
References:
citation: Abanes JJ, Ridner SH, Dietrich MS, Hiers C, Rhoten B. Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members: A Randomized Controlled Trial. Clin Nurs Res. 2022 Feb;31(2):239-250. doi: 10.1177/10547738211030602. Epub 2021 Jul 6.
citation: Abanes J, Ridner SH, Rhoten B. Perceived benefits of brief acupuncture for sleep disturbances in postdeployment military service members. J Clin Sleep Med. 2021 Aug 1;17(8):1533-1543. doi: 10.5664/jcsm.9222.