Clinical trial NCT03423394: Efficacy Trial of Stress Check-Up
Official title: Improving Voluntary Engagement for PTSD Treatment Among Service Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Motivational enhancement therapy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-02-06
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Untreated posttraumatic stress disorder (PTSD) is associated with high societal and individual costs. Effective interventions for symptoms of posttraumatic stress (PTS) exist but are underutilized by those who could benefit, especially among active duty military. This study will develop and test a brief telephone-delivered motivational enhancement intervention (MET) for military personnel (active, reserve, or national guard) serving in the Army, Air Force, or Navy who are experiencing symptoms of PTS, but who are not currently engaged in PTS treatment. The goal of the intervention is to decrease stigma around seeking care, increase knowledge about treatment options, increase engagement in help-seeking behavior, all leading to reductions in PTS symptoms.

Detailed description: The health and well being of military personnel, and consequently the capacity for optimal functioning of military units, are compromised by posttraumatic stress disorder (PTSD). PTSD is associated with high personal and societal costs. Post-deployment rates of PTSD range from 5-20%; approximately 8% of combat exposed military personnel develop new onsets of PTSD. PTSD is frequently comorbid with other psychiatric disorders. Untreated PTSD is associated with high rates of suicide, medical services utilization, relationship impairment, legal difficulties, decreased worker productivity, and decreased military readiness.

While PTSD treatment can be effective, individuals with PTSD may not seek treatment. Drop out and medication noncompliance are common. Moreover, military personnel encounter both real and perceived barriers to seeking treatment. Given the availability of effective treatments contrasted with the low rates of military personnel who present and complete treatment, figuring out how to connect individuals with PTSD symptoms into treatment and then helping them to stay engaged is a high priority. Motivational enhancement therapy (MET) has shown promise in promoting treatment entry and enhancing both retention and successful outcomes. A brief, telephone-delivered MET called a "check-up," has shown promise in promoting self-initiated behavior change as well as voluntary treatment entry, enhanced retention, and more successful outcomes for substance abuse. Despite these promising findings, no work has focused on adapting MET for enhancing self-referral and treatment seeking with individuals with PTSD who are active duty and who are not already in treatment. Active duty military face additional challenges to entering treatment than veterans and thus specific research is necessary to evaluate whether similar programs would be efficacious for active duty personnel.

Adapting the "check-up" application with military personnel is warranted for three key reasons: (1) it has the potential of overcoming barriers to treatment-seeking, i.e., stigma and apprehension of a negative impact on one's military career; (2) it has the potential of attracting voluntary participation; and (3) protocols for disseminating this low cost intervention for use with deployed military can readily be developed and evaluated.

Eligibility criteria: Inclusion Criteria:

* Current PTSD
* Currently serving in the Army, Navy, or Air Force

Exclusion Criteria:

* Currently being treated (counseling and/or medication) for PTSD
* Non-fluency in English
* Evidence of psychosis
* Pending deployment that would preclude completion of follow-ups

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: 1 months
measure: Treatment Utilization
timeFrame: 3 months
measure: Treatment Reactions Scale
timeFrame: 3 months
Secondary outcomes:
measure: Depression Module from the Patient Health Questionnaire (PHQ-9)
timeFrame: 2 weeks
measure: Daily Drinking Questionnaire
timeFrame: 1 week
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Innovative Programs Research Group
state: Washington
Study officials:
References:
citation: Kaysen D, Walton TO, Rhew IC, Jaffe AE, Pierce AR, Walker DD. Development of StressCheck: A telehealth motivational enhancement therapy to improve voluntary engagement for PTSD treatment among active-duty service members. Contemp Clin Trials. 2022 Aug;119:106841. doi: 10.1016/j.cct.2022.106841. Epub 2022 Jun 28.