Antidepressants + Therapy for PTSD
(STEPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to identify the best treatment for PTSD (Post-Traumatic Stress Disorder) in primary care settings, particularly for those unresponsive to initial treatment. It compares the effectiveness of antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), with a therapy called Written Exposure Therapy (WET) for individuals with PTSD. Participants will begin with either an antidepressant or WET, and if no improvement occurs after four months, they will switch or add another treatment. This trial is ideal for those with PTSD who have experienced trauma and are not currently receiving specialized mental health care. The goal is to assist patients and doctors in deciding on the best treatment plan in primary care environments. As a Phase 4 trial, this research focuses on understanding how already FDA-approved treatments can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have changed any psychotropic prescriptions in the past 2 months or if you are currently taking venlafaxine.
What is the safety track record for these treatments?
Research has shown that the treatments studied for PTSD in this trial—SSRIs, SNRIs, and Written Exposure Therapy (WET)—vary in safety and tolerability among individuals.
SSRIs, such as sertraline and paroxetine, are generally safe and well-tolerated for PTSD. These medications are commonly used and have a strong record of reducing PTSD symptoms, though some individuals might experience side effects like nausea or trouble sleeping.
SNRIs, including venlafaxine, are also considered safe. The FDA has approved them for conditions like depression and anxiety. Venlafaxine has shown significant improvement in PTSD symptoms, although it is less studied for PTSD compared to SSRIs. Some users might experience side effects like dizziness or dry mouth.
Written Exposure Therapy (WET) is a newer treatment but has been found safe and effective for managing PTSD. It is a brief and straightforward therapy, allowing for quick completion, and has shown good results even for those with other mood or substance use issues.
Overall, these treatments have a good safety record, but individual experiences with side effects can vary.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for PTSD because they combine medications and therapy in innovative ways. Unlike standard antidepressant treatments that often rely solely on SSRIs like sertraline, fluoxetine, or paroxetine, this approach offers three distinct strategies. One strategy augments SSRI treatment with Written Exposure Therapy (WET) if patients don't respond within four months, potentially enhancing therapeutic outcomes. Another switches non-responders from SSRIs to SNRIs, such as venlafaxine, aiming to target PTSD symptoms with a different mechanism of action. Lastly, starting with WET and switching to an SSRI if needed provides a unique combination that leverages therapy first, which might be beneficial for those who prefer non-pharmacological interventions initially. These tailored combinations give researchers hope for more personalized and effective treatment pathways for individuals with PTSD.
What evidence suggests that this trial's treatments could be effective for PTSD?
Research has shown that certain medications and therapies effectively treat PTSD. In this trial, participants may receive SSRIs, such as sertraline and fluoxetine, often chosen first because they improve symptoms. Another treatment arm uses venlafaxine, an SNRI, which proved more effective than a placebo. The trial also studies Written Exposure Therapy (WET) as an option that reduces PTSD symptoms, even in complex cases. WET is appealing because it requires less time while still providing good results. Overall, research strongly supports these treatments for managing PTSD symptoms.12678
Are You a Good Fit for This Trial?
This trial is for adults with PTSD who have experienced trauma, as indicated by specific screening tests. It's not for those under 18, recently changed psychotropic meds, prefer specialty mental health care, prisoners, non-English/Spanish speakers, terminally ill or decision-impaired individuals. Also excluded are those on venlafaxine or diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder or dementia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants are randomized to receive either pharmacotherapy (SSRI) or brief psychotherapy (WET) for PTSD
Treatment Adjustment
For non-responders, treatment is adjusted: SSRI treatment is augmented with WET, switched to SNRI, or WET is switched to SSRI
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Selective serotonin reuptake inhibitor
- Serotonin-norepinephrine reuptake inhibitor
- Written Exposure Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Stanford University
Collaborator
Boston University
Collaborator
Washington State University
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator