PTSDPhase 4STEPSNCT04597190
Sequenced Treatment Effectiveness for Posttraumatic Stress
A Phase 4 study testing Selective serotonin reuptake inhibitor, Serotonin-norepinephrine reuptake inhibitor and Written Exposure Therapy in people with PTSD, run by University of Washington at 15 sites in United States.
Trial summary
Individuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use, drug use, alcohol misuse, and have high rates of morbidity/mortality. PTSD negatively impacts marriages, educational attainment, and occupational functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Selective serotonin reuptake inhibitor, Serotonin-norepinephrine reuptake inhibitor and Written Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Jun 2020to 1 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Screen positive for PTSD (PC-PTSD>=3 AND PCL>=33)
- Screen positive for trauma (Brief Trauma questionnaire)
Who cannot join
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or dementia
- Current prescription of venlafaxine
- Change in any psychotropic prescription in the past 2 months
- A scheduled specialty mental health appointment or preference for specialty mental health care
- Pregnant
- Terminally ill
Show all 10Show fewer
- Prisoner
- Unable to communicate in English or Spanish
- <18 years of age
- Impaired decision making capacity
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Ann Arbor VA Medical Center
Ann Arbor, Michigan, 49109
VA Eastern Colorado Health Care
Aurora, Colorado, 80045
Bedford VA Medical Center
Bedford, Massachusetts, 01730
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
Upper Great Lakes Family Health Center
Hancock, Michigan, 49930
Partnership Health Center
Missoula, Montana, 59802
Little Rock VA Medical Center
North Little Rock, Arkansas, 72214
Portland VA Medical Center
Portland, Oregon, 97239
Neighborhood Healthcare
San Diego, California, 92025
San Diego VA Medical Center
San Diego, California, 92161
Healthpoint
SeaTac, Washington, 98188
Family Medical Center of Michigan
Temperance, Michigan, 48182
East Arkansas Family Health Center
West Memphis, Arkansas, 72301
North Central Texas Community Health Center
Wichita Falls, Texas, 76301
About this study
Official title: Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care
Individuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use, drug use, alcohol misuse, and have high rates of morbidity/mortality. PTSD negatively impacts marriages, educational attainment, and occupational functioning. Some patients with PTSD can be successfully referred to specialty mental health clinics, but most patients with PTSD cannot engage in specialty care because of geographical, financial and cultural barriers and must be treated in primary care. However, policy makers do not know the best way to treat PTSD in primary care clinics, especially for patients who do not respond to the initial treatment choice. There are effective treatments for PTSD that are feasible to deliver in primary care. These treatments include commonly prescribed antidepressants and brief exposure-based therapies. However, because there are no head-to-head comparisons between pharmacotherapy and psychotherapy in primary care settings, primary care providers do not know which treatments to recommend to their patients. In addition, despite high treatment non-response rates, very few studies have examined which treatment should be recommend next when patients do not respond well to the first, and no such studies have been conducted in primary care settings.
This trial will be conducted in Federally Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma exposure and PTSD are particularly high. The investigators will enroll 700 primary care patients. The investigators propose to 1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy, 2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and 3) examine variation in treatment outcomes among different subgroups of patients. Telephone and web surveys will be used to assessed outcomes important to patients, like self-reported symptom burden, side-effects, health related quality of life, and recovery outcomes, at baseline, 4 and 8 months. Results will help patients and primary care providers choose which treatment to try first and which treatment to try second if the first is not effective.
Read the detailed description
Background: In primary care settings, PTSD frequently goes undetected and untreated. When PTSD is diagnosed in primary care, treatment is usually inadequate and outcomes are poor. This is highly problematic because many patients with PTSD prefer receiving care in primary care settings, and less than half are successfully referred to the specialty mental health setting. This is especially a concern for safety net primary settings such as Federally Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma exposure and PTSD are particularly high. However, there are effective pharmacotherapy and psychotherapy treatments for PTSD that are feasible to deliver in primary care.
Objective: Because there are no head-to-head comparisons of pharmacotherapy and psychotherapy for PTSD among primary care patients, the investigators propose to 1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy, 2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and 3) examine variation in treatment outcomes among different subgroups of patients.
Methods: This multi-site trial will enroll 700 patients meeting clinical criteria for PTSD from 7 Federally Qualified Health Centers and 8 VA Medical Centers. The pharmacotherapy treatments are sertraline, fluoxetine, paroxetine and venlafaxine. The psychotherapy treatment is Written Exposure Therapy. Telephone and web surveys will be used to assessed outcomes (patient treatment engagement, self-reported symptom burden, health related quality of life, and recovery outcomes) at baseline, 4 and 8 months. Patients will be the unit of the intent-to-treat analysis. Multiple imputation will be used for missing data. Mixed-models will be used to test hypotheses.
Significance: Due to a lack of head-to-head comparisons between pharmacotherapy and psychotherapy protocols, clinical practice guidelines for PTSD provide contradictory recommendations about pharmacotherapy and psychotherapy. In particular, PTSD clinical practice guidelines have little to offer primary care providers because so few trials have been conducted in this setting. The proposed large pragmatic trial will compare, head-to-head, FDA approved PTSD medications with a brief trauma-focused psychotherapy that is evidence-based and feasible to deliver in primary care. In addition, despite high treatment non-response rates, very few trials have examined treatment sequencing and none have done so in the primary care setting. For patients not responding to the initial treatment, the proposed research is powered to compare, head-to-head, alternative treatment sequences that are feasible to deliver in primary care.
- Conditions
- PTSD
- Being tested
- Selective serotonin reuptake inhibitor, Serotonin-norepinephrine reuptake inhibitor, Written Exposure Therapy
- Keywords
- antidepressants, exposure therapy, primary care
- 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.
Selective serotonin reuptake inhibitorDrug
Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
Serotonin-norepinephrine reuptake inhibitorDrug
Prescribers will prescribe venlafaxine.
Written Exposure TherapyBehavioural
Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation about symptoms of PTSD, provides a treatment rationale for approaching the trauma memory, and discusses the use of writing as a means of doing so. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The session ends with the therapist instructing the patient to allow themselves to experience any trauma-related memories, images, thoughts, and feelings in the interval between sessions. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
| Study group | Role | What they receive |
|---|---|---|
| SSRI Then Augmentation by WET | Active comparator | Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant. Receives: Drug: Selective serotonin reuptake inhibitor; Behavioral: Written Exposure Therapy |
| SSRI Then Switch to SNRI | Active comparator | Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine. Receives: Drug: Selective serotonin reuptake inhibitor; Drug: Serotonin-norepinephrine reuptake inhibitor |
| WET Then Switch to SSRI | Active comparator | Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine). Receives: Drug: Selective serotonin reuptake inhibitor; Behavioral: Written Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms
Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
Measured: 4 months (Hypothesis 1)
PTSD Symptoms
Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
Measured: 8 Months (Hypotheses 2a and 2b)
Secondary outcomes (6)
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score
SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
Measured: 4 months (Hypothesis 1)
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score
SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
Measured: 8 Months (Hypotheses 2a and 2b)
Depression Symptoms
Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
Measured: 4 months (Hypothesis 1)
Depression Symptoms
Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
Measured: 8 Months (Hypotheses 2a and 2b)
Generalized Anxiety Symptoms
Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
Measured: 4 months (Hypothesis 1)
Generalized Anxiety Symptoms
Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
Measured: 8 Months (Hypotheses 2a and 2b)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jun 2020
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to treatment sequences, stratified by site and baseline antidepressant use.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Boston University, Washington State University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, John Cooper Fortney, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597190
- Sponsor's protocol ID
- STUDY00011185
- Acronym
- STEPS
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2020
- Last updated
- 8 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A public use dataset will be hosted by the Patient-Centered Outcomes Research Institute Data Repository hosted by Inter-university Consortium for Political and Social Research (ICPSR), the University of Michigan's Institute for Social Research.
Publications
Fortney JC, Kaysen DL, Engel CC, Cerimele JM, Nolan JP Jr, Chase E, Blanchard BE, Hauge S, Bechtel J, Taylor A, Acierno R, Nagel N, Sripada RK, Painter JT, DeBeer BB, Zimberoff A, Bluett EJ, Teo AR, Morland LA, Grubbs K, Sloan DM, Marx BP, Heagerty PJ. Pragmatic Comparative Effectiveness of Primary Care Treatments for Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1203-1215. doi: 10.1001/jamapsychiatry.2025.2962.
PubMed 41091477
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care
- ClinicalTrials.gov ID
- NCT04597190
- Acronym / sponsor ID
- STEPS / STUDY00011185
- Conditions
- PTSD
- Keywords
- antidepressants, exposure therapy, primary care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Stanford University, Boston University, Washington State University, Patient-Centered Outcomes Research Institute
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use, drug use, alcohol misuse, and have high rates of morbidity/mortality. PTSD negatively impacts marriages, educational attainment, and occupational functioning. Some patients with PTSD can be successfully referred to specialty mental health clinics, but most patients with PTSD cannot engage in specialty care because of geographical, financial and cultural barriers and must be treated in primary care. However, policy makers do not know the best way to treat PTSD in primary care clinics, especially for patients who do not respond to the initial treatment choice. There are effective treatments for PTSD that are feasible to deliver in primary care. These treatments include commonly prescribed antidepressants and brief exposure-based therapies. However, because there are no head-to-head comparisons between pharmacotherapy and psychotherapy in primary care settings, primary care providers do not know which treatments to recommend to their patients. In addition, despite high treatment non-response rates, very few studies have examined which treatment should be recommend next when patients do not respond well to the first, and no such studies have been conducted in primary care settings.
This trial will be conducted in Federally Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma exposure and PTSD are particularly high. The investigators will enroll 700 primary care patients. The investigators propose to 1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy, 2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and 3) examine variation in treatment outcomes among different subgroups of patients. Telephone and web surveys will be used to assessed outcomes important to patients, like self-reported symptom burden, side-effects, health related quality of life, and recovery outcomes, at baseline, 4 and 8 months. Results will help patients and primary care providers choose which treatment to try first and which treatment to try second if the first is not effective.
Detailed description
Background: In primary care settings, PTSD frequently goes undetected and untreated. When PTSD is diagnosed in primary care, treatment is usually inadequate and outcomes are poor. This is highly problematic because many patients with PTSD prefer receiving care in primary care settings, and less than half are successfully referred to the specialty mental health setting. This is especially a concern for safety net primary settings such as Federally Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma exposure and PTSD are particularly high. However, there are effective pharmacotherapy and psychotherapy treatments for PTSD that are feasible to deliver in primary care.
Objective: Because there are no head-to-head comparisons of pharmacotherapy and psychotherapy for PTSD among primary care patients, the investigators propose to 1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy, 2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and 3) examine variation in treatment outcomes among different subgroups of patients.
Methods: This multi-site trial will enroll 700 patients meeting clinical criteria for PTSD from 7 Federally Qualified Health Centers and 8 VA Medical Centers. The pharmacotherapy treatments are sertraline, fluoxetine, paroxetine and venlafaxine. The psychotherapy treatment is Written Exposure Therapy. Telephone and web surveys will be used to assessed outcomes (patient treatment engagement, self-reported symptom burden, health related quality of life, and recovery outcomes) at baseline, 4 and 8 months. Patients will be the unit of the intent-to-treat analysis. Multiple imputation will be used for missing data. Mixed-models will be used to test hypotheses.
Significance: Due to a lack of head-to-head comparisons between pharmacotherapy and psychotherapy protocols, clinical practice guidelines for PTSD provide contradictory recommendations about pharmacotherapy and psychotherapy. In particular, PTSD clinical practice guidelines have little to offer primary care providers because so few trials have been conducted in this setting. The proposed large pragmatic trial will compare, head-to-head, FDA approved PTSD medications with a brief trauma-focused psychotherapy that is evidence-based and feasible to deliver in primary care. In addition, despite high treatment non-response rates, very few trials have examined treatment sequencing and none have done so in the primary care setting. For patients not responding to the initial treatment, the proposed research is powered to compare, head-to-head, alternative treatment sequences that are feasible to deliver in primary care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized to treatment sequences, stratified by site and baseline antidepressant use.
| Arm | Type | Receives |
|---|---|---|
| SSRI Then Augmentation by WET | Active comparator | Drug: Selective serotonin reuptake inhibitor, Behavioral: Written Exposure TherapyPrescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant. |
| SSRI Then Switch to SNRI | Active comparator | Drug: Selective serotonin reuptake inhibitor, Drug: Serotonin-norepinephrine reuptake inhibitorPrescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine. |
| WET Then Switch to SSRI | Active comparator | Drug: Selective serotonin reuptake inhibitor, Behavioral: Written Exposure TherapyIntegrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Screen positive for PTSD (PC-PTSD>=3 AND PCL>=33)
- Screen positive for trauma (Brief Trauma questionnaire)
Key exclusion criteria (10 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or dementia
- Current prescription of venlafaxine
- Change in any psychotropic prescription in the past 2 months
- A scheduled specialty mental health appointment or preference for specialty mental health care
- Pregnant
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 |
|---|---|---|
| Selective serotonin reuptake inhibitorPrescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up). | Drug | SSRI Then Augmentation by WET, SSRI Then Switch to SNRI, WET Then Switch to SSRI |
| Serotonin-norepinephrine reuptake inhibitorPrescribers will prescribe venlafaxine. | Drug | SSRI Then Switch to SNRI |
| Written Exposure TherapyWritten Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation about symptoms of PTSD, provides a treatment rationale for approaching the trauma memory, and discusses the use of writing as a means of doing so. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The session ends with the therapist instructing the patient to allow themselves to experience any trauma-related memories, images, thoughts, and feelings in the interval between sessions. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session. | Behavioural | SSRI Then Augmentation by WET, WET Then Switch to SSRI |
Primary outcome
PTSD Symptoms
Time frame: 4 months (Hypothesis 1)
Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
PTSD Symptoms
Time frame: 8 Months (Hypotheses 2a and 2b)
Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
6 secondary outcomes
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score
Time frame: 4 months (Hypothesis 1)
Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score
Time frame: 8 Months (Hypotheses 2a and 2b)
Depression Symptoms
Time frame: 4 months (Hypothesis 1)
Depression Symptoms
Time frame: 8 Months (Hypotheses 2a and 2b)
Generalized Anxiety Symptoms
Time frame: 4 months (Hypothesis 1)
Generalized Anxiety Symptoms
Time frame: 8 Months (Hypotheses 2a and 2b)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41091477Fortney JC, Kaysen DL, Engel CC, Cerimele JM, Nolan JP Jr, Chase E, Blanchard BE, Hauge S, Bechtel J, Taylor A, Acierno R, Nagel N, Sripada RK, Painter JT, DeBeer BB, Zimberoff A, Bluett EJ, Teo AR, Morland LA, Grubbs K, Sloan DM, Marx BP, Heagerty PJ. Pragmatic Comparative Effectiveness of Primary Care Treatments for Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1203-1215. doi: 10.1001/jamapsychiatry.2025.2962.
- Individual participant dataSharing planned: Yes. A public use dataset will be hosted by the Patient-Centered Outcomes Research Institute Data Repository hosted by Inter-university Consortium for Political and Social Research (ICPSR), the University of Michigan's Institute for Social Research.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective serotonin reuptake inhibitor, Serotonin-norepinephrine reuptake inhibitor and Written Exposure Therapy in people with PTSD, run by University of Washington at 15 sites 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 10 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 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PTSD Symptoms (time frame: 4 months (Hypothesis 1)). The study lists 2 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 NCT04597190, which also lists 1 linked publication.
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 8 May 2025.