Posttraumatic Stress DisorderNCT03423394
Efficacy Trial of Stress Check-Up
A study testing Motivational Enhancement Therapy and Treatment as Usual in people with Posttraumatic Stress Disorder, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Motivational Enhancement Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2018to 30 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current PTSD
- Currently serving in the Army, Navy, or Air Force
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Innovative Programs Research Group
Seattle, Washington, 98105
About this study
Official title: Improving Voluntary Engagement for PTSD Treatment Among Service Members
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.
Read the 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
- Being tested
- Motivational Enhancement Therapy, Treatment as Usual
- Keywords
- Motivational enhancement therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement TherapyBehavioural
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 UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 3 months
Secondary outcomes (3)
Depression Module from the Patient Health Questionnaire (PHQ-9)
Measure that asks respondents to rate frequency of nine depressive symptoms over the past two weeks.
Measured: 2 weeks
Daily Drinking Questionnaire
Measure that asks the respondent to think about a typical week and estimate the typical number of drinks he or she consumes each day of that week.
Measured: 1 week
Alcohol Use Disorder Identification Test (AUDIT)
Measure that asks about the respondent's alcohol use.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start5 Jan 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
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 Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Denise Walker, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423394
- Sponsor's protocol ID
- STUDY00002794
- Other IDs
- W81XWH-17-1-0002
- Status last verified
- Sep 2021
- First submitted
- 9 Jan 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37824257Jaffe 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.
PubMed 36728194Kaysen 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.
PubMed 35777697
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Voluntary Engagement for PTSD Treatment Among Service Members
- ClinicalTrials.gov ID
- NCT03423394
- Acronym / sponsor ID
- STUDY00002794
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Motivational enhancement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Feb 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Enhancement Therapy | Experimental | Behavioral: Motivational Enhancement TherapyThe 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. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current PTSD
- Currently serving in the Army, Navy, or Air Force
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Motivational Enhancement TherapyThe 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. | Behavioural | Motivational Enhancement Therapy |
| Treatment as UsualTAU 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. | Behavioural | Treatment as Usual |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: 1 months
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.
Treatment Utilization
Time frame: 3 months
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.
Treatment Reactions Scale
Time frame: 3 months
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 secondary outcomes
Depression Module from the Patient Health Questionnaire (PHQ-9)
Time frame: 2 weeks
Daily Drinking Questionnaire
Time frame: 1 week
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: 6 months
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 3 Nov 2022.
- Derived from this study: PubMed 37824257Walker 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.
- Derived from this study: PubMed 36728194Jaffe 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.
- Derived from this study: PubMed 35777697Kaysen 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.
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
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 Motivational Enhancement Therapy and Treatment as Usual in people with Posttraumatic Stress Disorder, run by University of Washington at 1 site in United States.
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 2 inclusion and 4 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 3 Nov 2022. 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 United States. 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?
Clinician Administered PTSD Scale (CAPS) (time frame: 1 months). The study lists 3 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 NCT03423394, 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 3 Nov 2022.