Sequenced Treatment Effectiveness for Posttraumatic Stress
- Conditions
- PTSD
- Interventions
- Drug: Selective serotonin reuptake inhibitorBehavioral: Written Exposure TherapyDrug: Serotonin-norepinephrine reuptake inhibitor
- Registration Number
- NCT04597190
- Lead Sponsor
- University of Washington
- Brief 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. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 700
- Screen positive for PTSD (PC-PTSD>=3 AND PCL>=33)
- Screen positive for trauma (Brief Trauma questionnaire)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WET Then Switch to SSRI Written Exposure Therapy 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). SSRI Then Augmentation by WET Written Exposure Therapy 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 Serotonin-norepinephrine reuptake inhibitor 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. SSRI Then Augmentation by WET Selective serotonin reuptake inhibitor 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 Selective serotonin reuptake inhibitor 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 Selective serotonin reuptake inhibitor 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).
- Primary Outcome Measures
Name Time Method Change in PTSD symptoms 4 months (Hypothesis 1) Change in Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
PTSD symptoms 8 Months (Hypotheses 2a and 2b) Change in Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
- Secondary Outcome Measures
Name Time Method Change in Depression Symptoms 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 Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score 8 Months (Hypotheses 2a and 2b) Change in SF-12V, Mental Health Component Summary Score (range 0-100, higher scores are better)
Change in Generalized Anxiety Symptoms 8 Months (Hypotheses 2a and 2b) Change in Self reported burden of anxiety symptoms (GAD-7) (range 0-21, higher scores are worse)
Trial Locations
- Locations (15)
VA Eastern Colorado Health Care
🇺🇸Aurora, Colorado, United States
San Diego VA Medical Center
🇺🇸San Diego, California, United States
Bedford VA Medical Center
🇺🇸Bedford, Massachusetts, United States
Upper Great Lakes Family Health Center
🇺🇸Hancock, Michigan, United States
Family Medical Center of Michigan
🇺🇸Temperance, Michigan, United States
Cincinnati VA Medical Center
🇺🇸Cincinnati, Ohio, United States
Partnership Health Center
🇺🇸Missoula, Montana, United States
North Central Texas Community Health Center
🇺🇸Wichita Falls, Texas, United States
Healthpoint
🇺🇸SeaTac, Washington, United States
Little Rock VA Medical Center
🇺🇸North Little Rock, Arkansas, United States
East Arkansas Family Health Center
🇺🇸West Memphis, Arkansas, United States
Portland VA Medical Center
🇺🇸Portland, Oregon, United States
Neighborhood Healthcare
🇺🇸San Diego, California, United States
Ann Arbor VA Medical Center
🇺🇸Ann Arbor, Michigan, United States
Ralph H. Johnson VA Medical Center
🇺🇸Charleston, South Carolina, United States