Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members

NCT04031365 | Completed

• 1 other identifier: NHOK.2019.0055
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Acupuncture Expectancy Scale

  5 weeks

Other Outcomes (1)

• Posttraumatic Stress Disorder Checklist

  5 weeks

Study Arms (2)

Acupuncture and Cognitive Behavioral Therapy

EXPERIMENTAL

Participants will receive four sessions of a brief acupuncture therapy in addition to a brief cognitive behavioral therapy.

Procedure: Acupuncture; Behavioral: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Participants in this group will receive a brief cognitive behavioral therapy in addition to four telephone follow-ups.

Behavioral: Cognitive Behavioral Therapy

Interventions

Acupuncture PROCEDURE

Use of sterile, disposable needles in acupuncture

Acupuncture and Cognitive Behavioral Therapy

Cognitive Behavioral Therapy BEHAVIORAL

psychotherapy

Acupuncture and Cognitive Behavioral Therapy; Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

U.S. Naval Hospital Okinawa

Okinawa, Japan

Location

Related Publications (2)

• 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.

  PMID: 34229475 DERIVED

• 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.

  PMID: 33687323 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Acupuncture Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CDR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: October 14, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

JP (1)