Sleep DisturbanceNCT04031365
Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members
A study testing Acupuncture and Cognitive Behavioral Therapy in people with Sleep Disturbance, run by United States Naval Medical Center, San Diego at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Acupuncture and Cognitive Behavioral Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- 14 Oct 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Acupuncture, Cognitive Behavioral Therapy
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Use of sterile, disposable needles in acupuncture
Cognitive Behavioral TherapyBehavioural
psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and Cognitive Behavioral Therapy | Experimental | Participants will receive four sessions of a brief acupuncture therapy in addition to a brief cognitive behavioral therapy. Receives: 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. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 5 weeks
Secondary outcomes (1)
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).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start14 Oct 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jane J. Abanes, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031365
- Sponsor's protocol ID
- NHOK.2019.0055
- Status last verified
- Sep 2020
- First submitted
- 22 Jul 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abanes JJ, Raiciulescu S. Associations Between Sleep Disorders and Treatment Response in Service Members With Post-traumatic Stress Symptoms: A Secondary Outcome Analysis. Mil Med. 2025 Feb 27;190(3-4):e467-e473. doi: 10.1093/milmed/usae484.
PubMed 39405266Abanes 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.
PubMed 34229475Abanes 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.
PubMed 33687323
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members
- ClinicalTrials.gov ID
- NCT04031365
- Acronym / sponsor ID
- NHOK.2019.0055
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and Cognitive Behavioral Therapy | Experimental | Procedure: Acupuncture, Behavioral: Cognitive Behavioral TherapyParticipants will receive four sessions of a brief acupuncture therapy in addition to a brief cognitive behavioral therapy. |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyParticipants in this group will receive a brief cognitive behavioral therapy in addition to four telephone follow-ups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureUse of sterile, disposable needles in acupuncture | Procedure or surgery | Acupuncture and Cognitive Behavioral Therapy |
| Cognitive Behavioral Therapypsychotherapy | Behavioural | Acupuncture and Cognitive Behavioral Therapy, Cognitive Behavioral Therapy |
Primary outcome
Insomnia Severity Index
Time frame: 5 weeks
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).
Pittsburg Sleep Quality Index
Time frame: 5 weeks
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).
1 secondary outcome
Acupuncture Expectancy Scale
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Derived from this study: PubMed 39405266Abanes JJ, Raiciulescu S. Associations Between Sleep Disorders and Treatment Response in Service Members With Post-traumatic Stress Symptoms: A Secondary Outcome Analysis. Mil Med. 2025 Feb 27;190(3-4):e467-e473. doi: 10.1093/milmed/usae484.
- Derived from this study: PubMed 34229475Abanes 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.
- Derived from this study: PubMed 33687323Abanes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Cognitive Behavioral Therapy in people with Sleep Disturbance, run by United States Naval Medical Center, San Diego at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031365, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.