Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stanford University | OTHER |
| Boston University | OTHER |
| Washington State University | OTHER |
| Patient-Centered Outcomes Research Institute |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective serotonin reuptake inhibitor | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptoms | Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse) | 4 months (Hypothesis 1) |
| PTSD Symptoms | Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse) | 8 Months (Hypotheses 2a and 2b) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 months (Hypothesis 1) |
| Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Severe and Moderate Side Effects | Self reported severity of specific side-effects | 4 months (Hypothesis 1) |
| Number of Severe and Moderate Side Effects | Self reported severity of specific side-effects |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock VA Medical Center | North Little Rock | Arkansas | 72214 | United States | ||
| East Arkansas Family Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41091477 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SSRI Then Augmentation by WET | 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2024 | Nov 1, 2024 |
Not provided
Not provided
| OTHER |
Patients will be randomized to treatment sequences, stratified by site and baseline antidepressant use.
Not provided
Not provided
The survey team members will be masked to which arm the study participant has been randomized.
The PI, Co-PIs, and Co-Is will not have access to the outcomes until the primary data collection phase has been completed. The statistician will present outcomes by arm to the Data Safety Monitoring Board (DSMB) members during closed sessions of DSMB meetings.
|
| Serotonin-norepinephrine reuptake inhibitor | Drug | Prescribers will prescribe venlafaxine. |
|
| Written Exposure Therapy | Behavioral | 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. |
|
SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better) |
| 8 Months (Hypotheses 2a and 2b) |
| Depression Symptoms | Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse) | 4 months (Hypothesis 1) |
| Depression Symptoms | Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse) | 8 Months (Hypotheses 2a and 2b) |
| Generalized Anxiety Symptoms | Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse) | 4 months (Hypothesis 1) |
| Generalized Anxiety Symptoms | Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse) | 8 Months (Hypotheses 2a and 2b) |
| 8 Months (Hypotheses 2a and 2b) |
| West Memphis |
| Arkansas |
| 72301 |
| United States |
| Neighborhood Healthcare | San Diego | California | 92025 | United States |
| San Diego VA Medical Center | San Diego | California | 92161 | United States |
| VA Eastern Colorado Health Care | Aurora | Colorado | 80045 | United States |
| Bedford VA Medical Center | Bedford | Massachusetts | 01730 | United States |
| Ann Arbor VA Medical Center | Ann Arbor | Michigan | 49109 | United States |
| Upper Great Lakes Family Health Center | Hancock | Michigan | 49930 | United States |
| Family Medical Center of Michigan | Temperance | Michigan | 48182 | United States |
| Partnership Health Center | Missoula | Montana | 59802 | United States |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | United States |
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States |
| North Central Texas Community Health Center | Wichita Falls | Texas | 76301 | United States |
| Healthpoint | SeaTac | Washington | 98188 | United States |
| FG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| FG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SSRI Then Augmentation by WET | 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. |
| BG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| BG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| PTSD Check List (PCL-5) | 20-item measure of PTSD symptom severity (range 0-80). Higher scores represent greater severity. Cutoff score of 33 is considered a positive screen for PTSD. | Mean | Standard Deviation | units on a scale (range 0-80) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PTSD Symptoms | Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse) | Posted | Mean | Standard Deviation | units on a scale | 4 months (Hypothesis 1) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | PTSD Symptoms | Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse) | Participants not responding to treatment at 4-months who completed the 8-month survey | Posted | Mean | Standard Deviation | units on a scale | 8 Months (Hypotheses 2a and 2b) |
| |||||||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | 4 months (Hypothesis 1) |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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) | Participants not responding to treatment at 4-months who completed the 8-month survey | Posted | Mean | Standard Deviation | units on a scale | 8 Months (Hypotheses 2a and 2b) |
| |||||||||||||||||||||||||||||||||
| Secondary | Depression Symptoms | Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse) | Participants completing the 4-month survey | Posted | Mean | Standard Deviation | units on a scale | 4 months (Hypothesis 1) |
| |||||||||||||||||||||||||||||||||
| Secondary | Depression Symptoms | Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse) | Participants not responding to treatment at 4-months who completed the 8-month survey | Posted | Mean | Standard Deviation | units on a scale | 8 Months (Hypotheses 2a and 2b) |
| |||||||||||||||||||||||||||||||||
| Secondary | Generalized Anxiety Symptoms | Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse) | Participants completing the survey at 4-months | Posted | Mean | Standard Deviation | units on a scale | 4 months (Hypothesis 1) |
| |||||||||||||||||||||||||||||||||
| Secondary | Generalized Anxiety Symptoms | Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse) | Participants not responding to treatment at 4-months who completed the 8-month survey | Posted | Mean | Standard Deviation | units on a scale | 8 Months (Hypotheses 2a and 2b) |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Severe and Moderate Side Effects | Self reported severity of specific side-effects | Participants completing the 4-month survey | Posted | Mean | Standard Deviation | Number of side-effects | 4 months (Hypothesis 1) |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Severe and Moderate Side Effects | Self reported severity of specific side-effects | Participants not responding to treatment at 4-months who completed the 8-month survey | Posted | Mean | Standard Deviation | Number of side-effects | 8 Months (Hypotheses 2a and 2b) |
|
8 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SSRI Then Augmentation by WET | 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. | 0 | 169 | 32 | 169 | 34 | 169 |
| EG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. | 0 | 179 | 34 | 179 | 35 | 179 |
| EG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. | 1 | 352 | 63 | 352 | 60 | 352 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Investigations | Non-systematic Assessment |
| ||
| Emergency Department Admission | Investigations | Non-systematic Assessment |
| ||
| Suicide Intent | Investigations | Non-systematic Assessment |
| ||
| Other | Investigations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in suicide ideation | Investigations | Non-systematic Assessment |
| ||
| Non-suicidal injury | Investigations | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Fortney | University of Washington | 2066856955 | fortneyj@uw.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2024 | Nov 1, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
| Woman |
|
| Transgender Man |
|
| Transgender Women |
|
| Non-binary or gender fluid |
|
| Another identity |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Arab or Middle Eastern |
|
| Asian |
|
| Black or African American |
|
| Multi-race |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Another Identity |
|
| Missing |
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|
| OG001 | SSRI Then Switch to SNRI | 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. Selective serotonin reuptake inhibitor: 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 inhibitor: Prescribers will prescribe venlafaxine. |
| OG002 | WET Then Switch to SSRI | 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). Written Exposure Therapy: Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation. 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 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. Selective serotonin reuptake inhibitor: Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine. 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. |
|
|