Acupuncture for Sleep Disturbances in Post-Deployment Military Service Members
Condition: Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

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.
    

Intervention name(s): Acupuncture; Cognitive Behavioral Therapy
Intervention type(s): Procedure; Behavioral
Intervention description(s): Use of sterile, disposable needles in acupuncture; psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment