Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care
Comparing treatments for PTSD in primary care settings
Plain English Summary
Sequenced Treatment Effectiveness for Posttraumatic Stress is a Phase 4 clinical trial sponsored by University of Washington studying PTSD. This study compares how well two common treatments work for Post-Traumatic Stress Disorder (PTSD) when offered in regular doctor's offices. It is for adults who have been diagnosed with PTSD and are seeking care in primary care settings. Participants will be randomly assigned to receive either medication (like antidepressants) or a type of talk therapy (Written Exposure Therapy) as their first treatment, or a combination if the first treatment doesn't work well. Alternatives include seeking specialized mental health care, which can be difficult to access for many. The trial aims to enroll 700 participants.
Official 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 s
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who screen positive for PTSD and trauma. Individuals diagnosed with schizophrenia, bipolar disorder, dementia, or who are currently taking venlafaxine or have recently changed psychotropic medications. People who are pregnant, terminally ill, or currently in prison. Those unable to communicate in English or Spanish, or who have impaired decision-making abilities. This trial is studying PTSD, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how much PTSD symptoms improve over 4 to 8 months, indicating how effective the treatments are in reducing the distress and impact of PTSD. The specific primary outcome measures are: PTSD Symptoms (4 months (Hypothesis 1)); PTSD Symptoms (8 Months (Hypotheses 2a and 2b)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial is important because many people with PTSD cannot access specialized mental health care, and this study aims to find the best treatment options for them within primary care settings. This research targets PTSD, where improved treatment options are needed.
Investor Insight
This trial addresses a significant unmet need in primary care for PTSD treatment, potentially impacting a large patient population and influencing clinical guidelines, suggesting a strong market oppor This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes. The large enrollment target of 700 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific medications or therapy being offered and what to expect regarding side effects or the therapy process. Participation involves regular check-ins and assessments, which may include phone or web surveys, to track your progress. You may be asked to switch or add treatments if your initial treatment is not working effectively. The trial is being conducted at 15 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 700 participants
Interventions
- 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 wil
- DRUG: Serotonin-norepinephrine reuptake inhibitor — Prescribers will prescribe venlafaxine.
- 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
Primary Outcomes
- PTSD Symptoms (4 months (Hypothesis 1))
- PTSD Symptoms (8 Months (Hypotheses 2a and 2b))
Secondary Outcomes
- Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score (4 months (Hypothesis 1))
- Mental Health Related Quality of Life: SF-12V, Mental Health Component Summary Score (8 Months (Hypotheses 2a and 2b))
- Depression Symptoms (4 months (Hypothesis 1))
- Depression Symptoms (8 Months (Hypotheses 2a and 2b))
- Generalized Anxiety Symptoms (4 months (Hypothesis 1))
Full Eligibility Criteria
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
Trial Locations
- Little Rock VA Medical Center, North Little Rock, Arkansas, United States
- East Arkansas Family Health Center, West Memphis, Arkansas, United States
- Neighborhood Healthcare, San Diego, California, United States
- San Diego VA Medical Center, San Diego, California, United States
- VA Eastern Colorado Health Care, Aurora, Colorado, United States
- Bedford VA Medical Center, Bedford, Massachusetts, United States
- Ann Arbor VA Medical Center, Ann Arbor, Michigan, United States
- Upper Great Lakes Family Health Center, Hancock, Michigan, United States
- Family Medical Center of Michigan, Temperance, Michigan, United States
- Partnership Health Center, Missoula, Montana, United States
- ...and 5 more locations
Frequently Asked Questions
What is clinical trial NCT04597190?
NCT04597190 is a Phase 4 INTERVENTIONAL study titled "Sequenced Treatment Effectiveness for Posttraumatic Stress." It is currently completed and is sponsored by University of Washington. The trial targets enrollment of 700 participants.
What conditions does NCT04597190 study?
This trial investigates treatments for PTSD. The primary condition under study is PTSD.
What treatments are being tested in NCT04597190?
The interventions being studied include: Selective serotonin reuptake inhibitor (DRUG), Serotonin-norepinephrine reuptake inhibitor (DRUG), Written Exposure Therapy (BEHAVIORAL). 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 wil
What does Phase 4 mean for NCT04597190?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT04597190?
This trial is currently "Completed." It started on 2020-06-01. The estimated completion date is 2024-08-01.
Who is sponsoring NCT04597190?
NCT04597190 is sponsored by University of Washington. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04597190?
The trial aims to enroll 700 participants. The trial status is completed.
How is NCT04597190 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT04597190?
The primary outcome measures are: PTSD Symptoms (4 months (Hypothesis 1)); PTSD Symptoms (8 Months (Hypotheses 2a and 2b)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04597190 being conducted?
This trial is being conducted at 15 sites, including North Little Rock, Arkansas; West Memphis, Arkansas; San Diego, California; Aurora, Colorado and 11 more sites (United States).
Where can I find official information about NCT04597190?
The official record for NCT04597190 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04597190. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04597190 testing in simple terms?
This study compares how well two common treatments work for Post-Traumatic Stress Disorder (PTSD) when offered in regular doctor's offices. It is for adults who have been diagnosed with PTSD and are seeking care in primary care settings.
Why is this trial significant?
This trial is important because many people with PTSD cannot access specialized mental health care, and this study aims to find the best treatment options for them within primary care settings.
What are the potential risks of participating in NCT04597190?
Medications like SSRIs can cause side effects such as nausea, insomnia, or sexual dysfunction. Written Exposure Therapy involves writing about traumatic memories, which can be emotionally challenging. There is a possibility that initial treatments may not be fully effective, requiring a switch to alternative therapies. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04597190?
Ask your doctor about the specific medications or therapy being offered and what to expect regarding side effects or the therapy process. Participation involves regular check-ins and assessments, which may include phone or web surveys, to track your progress. You may be asked to switch or add treatments if your initial treatment is not working effectively. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04597190 signal from an investment perspective?
This trial addresses a significant unmet need in primary care for PTSD treatment, potentially impacting a large patient population and influencing clinical guidelines, suggesting a strong market oppor This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to receive either medication (like antidepressants) or a type of talk therapy (Written Exposure Therapy) as their first treatment, or a combination if the first treatment doesn't work well. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More PTSD Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.