Efficacy Trial of Stress Check-Up

NCT03423394 | Completed

• 2 other identifiers: STUDY00002794W81XWH-17-1-0002
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Motivational enhancement therapy

Outcome Measures

Primary Outcomes (3)

• Clinician Administered PTSD Scale (CAPS)

  The Clinician Administered PTSD Scale (CAPS) is a structured, clinician-administered interview that assesses the severity of each of the PTSD symptoms listed in Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and yields a clinical PTSD diagnosis and overall severity rating. The CAPS total severity rating ranges from 0-80, with higher scores indicating greater PTSD severity.

  1 months

• Treatment Utilization

  The Treatment Utilization questionnaire asks about current and past use of different treatment services. Part 1: Participants are asked (yes/no) if they have ever participated in treatment or support for different concerns (i.e., depression, marital or family concerns, posttraumatic stress, smoking cessation, anger management, and drinking or drug use) and then asked to identify type of treatment or support (i.e., self help, group therapy, individual therapy, medication, inpatient/ residential program, and other) they received for any of the concerns they reported "yes". Part 2: Participants are asked (yes/no/not applicable) if they have participated in treatment or support for any of the concerns reported in Part 1 in the past 3 months. Part 3: Participants are asked (yes/no) about their use of treatment and support resources used in the past 3 months for dealing with psychological or emotional concerns related to a traumatic event.

  3 months

• Treatment Reactions Scale

  The Treatment Reactions Scale (TRS) is a 31-item measure that assesses the respondent's perceptions of treatment for mental and behavioral health. The TRS total score ranges from 31-155, with lower scores indicating more favorable reactions to treatment. The TRS consists of 5 subscales: Embarrassment/shame for seeking treatment (5 items, range 5-25; lower score indicates less embarrassment/shame for seeking treatment) Occupational/career impact of seeking treatment (4 items, range 4-20; lower score indicates less occupational/career impact of seeking treatment) Perceived debasement for receiving treatment (9 items, range 9-45; lower score indicates less perceived debasement for receiving treatment) Willingness to recommend treatment (7 items, range 7-35; lower score indicates more willingness to recommend treatment) Confidence in/belief in the efficacy of treatment (6 items, range 6-30; lower score indicates more confidence in/belief in the efficacy of treatment)

  3 months

Secondary Outcomes (3)

• Depression Module from the Patient Health Questionnaire (PHQ-9)

  2 weeks

• Daily Drinking Questionnaire

  1 week

• Alcohol Use Disorder Identification Test (AUDIT)

  6 months

Study Arms (2)

Motivational Enhancement Therapy

EXPERIMENTAL

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.

Behavioral: Motivational Enhancement Therapy

Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual

Interventions

Motivational Enhancement Therapy 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.

Motivational Enhancement Therapy

Treatment as Usual 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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Washington Innovative Programs Research Group

Seattle, Washington, 98105, United States

Location

Related Publications (3)

• 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.

  PMID: 37824257 DERIVED

• 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.

  PMID: 36728194 DERIVED

• 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.

  PMID: 35777697 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Motivational Interviewing; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor, School of Social Work

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 6, 2018
• Study Start: January 5, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 3, 2022

Record last verified: 2021-09

Locations

US (1)