Efficacy Trial of Stress Check-Up

NCT ID: NCT03423394

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-05
• Study Completion Date: 2021-09-30

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Motivational Enhancement Therapy

The MET intervention will consist of three 45-90 minute telephone delivered sessions that will be staggered to occur 1 week, 1 month, and 2 months after the baseline assessment.

Group Type: EXPERIMENTAL

Motivational Enhancement Therapy

Intervention Type: BEHAVIORAL

The MET intervention will consist of three 45-90 minute telephone delivered sessions that will be staggered to occur 1 week, 1 month, and 2 months after the baseline assessment. The first MET session intervention will involve a counselor using motivational interviewing (MI) strategies to establish an empathic therapeutic relationship and focus learning about the PTSD symptoms the participant is experiencing and exploring ambivalence about seeking treatment services. MET sessions 2 and 3 will focus on identifying and responding to risk factors for dropping out of treatment (increases in ambivalence, avoidance behavior, concerns about stigma, life chaos), identifying and responding to barriers to participant's active engagement in treatment, and facilitating enrollment in alternate therapeutic resources if necessary.

Treatment as Usual

The treatment as usual (TAU) condition was selected to mirror the existing process in the military for identifying and encouraging treatment for personnel who screen positive for PTSD.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

TAU will include a written referral list comprised of PTSD resources including information on in-person treatments, self-help, web-based and bibliotherapy options. At the completion of the study, participants in the TAU condition will be offered the MET intervention.

Interventions

Motivational Enhancement Therapy

The MET intervention will consist of three 45-90 minute telephone delivered sessions that will be staggered to occur 1 week, 1 month, and 2 months after the baseline assessment. The first MET session intervention will involve a counselor using motivational interviewing (MI) strategies to establish an empathic therapeutic relationship and focus learning about the PTSD symptoms the participant is experiencing and exploring ambivalence about seeking treatment services. MET sessions 2 and 3 will focus on identifying and responding to risk factors for dropping out of treatment (increases in ambivalence, avoidance behavior, concerns about stigma, life chaos), identifying and responding to barriers to participant's active engagement in treatment, and facilitating enrollment in alternate therapeutic resources if necessary.

Intervention Type: BEHAVIORAL

Treatment as Usual

TAU will include a written referral list comprised of PTSD resources including information on in-person treatments, self-help, web-based and bibliotherapy options. At the completion of the study, participants in the TAU condition will be offered the MET intervention.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Denise Walker

Research Professor, School of Social Work

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Washington Innovative Programs Research Group

Seattle, Washington, United States

Countries

United States

References

Walker DD, Walton TO, Jaffe AE, Graupensperger S, Rhew IC, Kaysen D. Improving voluntary engagement for posttraumatic stress disorder treatment among active-duty service members using motivational enhancement therapy. Psychol Trauma. 2024 Dec;16(Suppl 3):S492-S501. doi: 10.1037/tra0001562. Epub 2023 Oct 12.

Reference Type: DERIVED

PMID: 37824257 (View on PubMed)

Jaffe AE, Walton TO, Walker DD, Kaysen DL. Social support and treatment utilization for posttraumatic stress disorder: Examining reciprocal relations among active duty service members. J Trauma Stress. 2023 Jun;36(3):537-548. doi: 10.1002/jts.22908. Epub 2023 Feb 2.

Reference Type: DERIVED

PMID: 36728194 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35777697 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

W81XWH-17-1-0002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00002794

Identifier Type: -

Identifier Source: org_study_id