Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members

Sleep Disturbance Clinical Trial

Official title:

Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031365
• Other study ID #: NHOK.2019.0055
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2020
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Procedure:
• Acupuncture
Use of sterile, disposable needles in acupuncture

Behavioral:
• Cognitive Behavioral Therapy
psychotherapy

Locations

Country	Name	City	State
Japan	U.S. Naval Hospital Okinawa	Okinawa

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Posttraumatic Stress Disorder Checklist	The PCL-5 is a 20-item scale that examines the degree of how an individual has been bothered by symptoms associated with a distressing event (Wortmann et al., 2016). Each item is rated from 0 (not at all bothered) to 4 (extremely bothered). Scores are summed to yield a severity score. Permissions to use the PCL-5 are not required (Keane, 1989; Weathers et al., 2013). The PCL-5 scale has good reliability and validity psychometrics (i.e., Cronbach's alpha = 0.75 to 0.95; r = 0.92 to 0.94) (Wortmann et al., 2016) and is widely used in both clinical and research settings.	5 weeks
Primary	Insomnia Severity Index	The ISI is a seven-item standardized self-report questionnaire that measures the subjective symptoms of SDs (C. Morin et al., 2011). These subjective symptoms include the respondents' concerns and distress as a result of problems with sleep. The ISI measure contains seven items including perceived difficulty with sleep-onset, sleep maintenance, and early morning awakenings; satisfaction with sleep patterns; interference of sleep problems with daily functioning; impairment as a result of a sleep problem; and degree of distress or concern with the sleep problem (Bastien, Vallieres, & Morin, 2001). Each item in the ISI is rated from 0 to 4 whereby the higher number indicates more difficulty. The scores are added to yield a range of total scores from 0 to 28 in which a higher score suggests more severe SDs. This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.91), sensitivity (78.1%), specificity (100.0%)(C. M. Morin, 2017).	5 weeks
Primary	Pittsburg Sleep Quality Index	The PSQI is a 19-item questionnaire that includes seven areas of sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction (Buysse et al., 1988). Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%)(Buysse et al., 1988).	5 weeks
Secondary	Acupuncture Expectancy Scale	Acupuncture Expectancy Scale (AES): The AES is a 4-item questionnaire that measures the participants' expected responses to acupuncture. Participants' expected improvement from acupuncture is rated in a 5-point Likert-type scale ranging from not at all agree to completely agree (Mao et al., 2010). The total possible scores for AES range from 4 to 20, with higher scores indicating greater expectancy. In an initial validation, the instrument's Cronbach's alpha is .82 (Mao et al., 2007). The AES has been found to be reliable, valid, and has acceptable sensitivity to change during treatment starting at week 4 of treatment with increasing statistically significant changes with more acupuncture treatments (Mao et al., 2010).	5 weeks