Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04597190 |
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Recruitment Status :
Recruiting
First Posted : October 22, 2020
Last Update Posted : August 4, 2022
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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, 3 and 6 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| PTSD | Drug: Selective serotonin reuptake inhibitor Drug: Serotonin-norepinephrine reuptake inhibitor Behavioral: Written Exposure Therapy | Phase 4 |
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 8 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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 700 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients will be randomized to treatment sequences, stratified by site and baseline antidepressant use. |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| Official Title: | Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care |
| Actual Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | February 28, 2024 |
| Estimated Study Completion Date : | February 28, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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.
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Drug: 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). Behavioral: Written Exposure Therapy 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. |
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Active Comparator: 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.
|
Drug: 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). Drug: Serotonin-norepinephrine reuptake inhibitor Prescribers will prescribe venlafaxine. |
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Active Comparator: 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).
|
Drug: 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). Behavioral: Written Exposure Therapy 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. |
- Change in PTSD symptoms [ Time Frame: 4 months (Hypothesis 1) ]Change in 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) ]Change in Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
- Change in Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score [ Time Frame: 4 months (Hypothesis 1) ]Change in SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
- Change in Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score [ Time Frame: 8 Months (Hypotheses 2a and 2b) ]Change in SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
- Change in Depression Symptoms [ Time Frame: 4 months (Hypothesis 1) ]Change in Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
- Change in Depression Symptoms [ Time Frame: 8 Months (Hypotheses 2a and 2b) ]Change in Self reported burden of depression symptoms (PHQ-9) (range 0-27, higher scores are worse)
- Change in Generalized Anxiety Symptoms [ Time Frame: 4 months (Hypothesis 1) ]Change in Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
- Change in Generalized Anxiety Symptoms [ Time Frame: 8 Months (Hypotheses 2a and 2b) ]Change in Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
- Number of Severe and Moderate Side Effects [ Time Frame: 4 months (Hypothesis 1) ]Self reported severity of specific side-effects
- Number of Severe and Moderate Side Effects [ Time Frame: 8 Months (Hypotheses 2a and 2b) ]Self reported severity of specific side-effects
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Screen positive for PTSD (PC-PTSD>=3 AND PCL>=33)
- Screen positive for trauma (Brief Trauma questionnaire)
Exclusion Criteria:
- 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
- Prisoner
- Unable to communicate in English or Spanish
- <18 years of age
- Impaired decision making capacity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597190
| Contact: John Fortney, PhD | 206.685.6955 | fortneyj@uw.edu | |
| Contact: Stephanie Hauge, MS | 206.616.6579 | shauge@uw.edu |
| United States, Arkansas | |
| Little Rock VA Medical Center | Recruiting |
| North Little Rock, Arkansas, United States, 72214 | |
| Contact: Jacob Painter, PhD 501-257-1740 Jacob.Painter@va.gov | |
| East Arkansas Family Health Center | Recruiting |
| West Memphis, Arkansas, United States, 72301 | |
| Contact: Djuana McNeeley, LCSW 870-733-6362 dsmith@eafhc.org | |
| United States, California | |
| Neighborhood Healthcare | Recruiting |
| San Diego, California, United States, 92025 | |
| Contact: Wendi Vierra, PhD 760-520-8342 wendi.vierra@nhcare.org | |
| San Diego VA Medical Center | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: Leslie Morland, PhD 858-552-4324 Leslie.Morland@va.gov | |
| United States, Colorado | |
| VA Eastern Colorado Health Care | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Tabitha Alverio, MA Tabitha.Alverio@va.gov | |
| United States, Louisiana | |
| Teche Action Clinic | Recruiting |
| Franklin, Louisiana, United States, 70538 | |
| Contact: Karla Vappie kvappie@tabhealth.org | |
| United States, Massachusetts | |
| Bedford VA Medical Center | Recruiting |
| Bedford, Massachusetts, United States, 01730 | |
| Contact: Rosanne Schipani, MD 781-687-2665 Rosanne.Schipani@va.gov | |
| United States, Michigan | |
| Ann Arbor VA Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 49109 | |
| Contact: Rebecca Sripada, PhD 734-222-7432 Rebecca.Sripada@va.gov | |
| Upper Great Lakes Family Health Center | Recruiting |
| Hancock, Michigan, United States, 49930 | |
| Contact: Brian Foreman, MS 906-483-1097 brian.foreman@uglhealth.org | |
| Family Medical Center of Michigan | Recruiting |
| Temperance, Michigan, United States, 48182 | |
| Contact: Jessica Parsil, MA, LLP 734-847-3802 ext x1444 jparsil@familymedical.org | |
| United States, Montana | |
| Partnership Health Center | Recruiting |
| Missoula, Montana, United States, 59802 | |
| Contact: Ellen Bluett, PhD 406-258-4123 bluette@phc.missoula.mt.us | |
| United States, Ohio | |
| Cincinnati VA Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45220 | |
| Contact: Nancy Nalgel, PsyD 513-801-7065 Nancy.Nagel@va.gov | |
| United States, Oregon | |
| Portland VA Medical Center | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Alan Teo, MD 503-220-8262 ext x52461 Alan.Teo@va.gov | |
| United States, South Carolina | |
| Ralph H. Johnson VA Medical Center | Recruiting |
| Charleston, South Carolina, United States, 29401 | |
| Contact: Wendy Muzzy, MRA, MLIS muzzy@musc.edu | |
| United States, Texas | |
| North Central Texas Community Health Center | Recruiting |
| Wichita Falls, Texas, United States, 76301 | |
| Contact: Ellaheh Ebrahim, MD eebrahim_md@chcwf.com | |
| United States, Washington | |
| Healthpoint | Recruiting |
| SeaTac, Washington, United States, 98188 | |
| Contact: Anya Zimberoff, PsyD 206-277-7204 azimberoff@healthpointchc.org | |
| Responsible Party: | John Fortney, Professor, School of Medicine, University of Washington |
| ClinicalTrials.gov Identifier: | NCT04597190 |
| Other Study ID Numbers: |
STUDY00011185 |
| First Posted: | October 22, 2020 Key Record Dates |
| Last Update Posted: | August 4, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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