Adaptive PTSD Interventions for PTSD
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Disqualifiers: Severe cognitive impairment, High suicide risk, Severe alcohol or substance use, Active psychosis, Unmanaged bipolar, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.
The central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that your psychotropic medication has been stable for at least 4 weeks before joining.
What data supports the effectiveness of the treatment Clinician Supported PTSD Coach App and Prolonged Exposure for PTSD?
Prolonged Exposure (PE) therapy, a key component of the treatment, is shown to be effective in reducing PTSD symptoms, with studies indicating medium-to-large reductions in PTSD and small-to-medium reductions in depression symptoms. PE for Primary Care (PE-PC), a brief version of PE, has been effective in primary care settings, making it more accessible for patients.
12345Is prolonged exposure therapy safe for humans?
Prolonged exposure therapy, including its version for primary care (PE-PC), is generally considered safe for treating PTSD, with studies showing it effectively reduces PTSD and depression symptoms. There is no specific mention of safety concerns in the research articles, suggesting it is well-tolerated by patients.
12356How is the treatment Prolonged Exposure for Primary Care (PE-PC) different from other PTSD treatments?
Prolonged Exposure for Primary Care (PE-PC) is a shorter, more accessible version of traditional prolonged exposure therapy, designed specifically for primary care settings. It involves four 30-minute sessions focusing on confronting trauma memories and related avoidance, making it more feasible for patients who prefer or have easier access to primary care rather than specialized mental health services.
12345Eligibility Criteria
This trial is for individuals with PTSD receiving care at certain Michigan health centers, who score ≥33 on the PTSD checklist and have stable psychotropic medication use for 4 weeks. They must own a mobile device compatible with the PTSD Coach App. Excluded are those currently in trauma-focused treatment, with severe cognitive impairment, non-English speakers, high suicide risk, active psychosis or unmanaged bipolar disorder, severe substance abuse issues, or unstable housing.Inclusion Criteria
Receive care at a participating federally qualified health center (FQHC)
Exclusion Criteria
I am currently in therapy for trauma, like Prolonged Exposure or Cognitive Processing Therapy.
Active psychosis or unmanaged bipolar disorder
Unstable housing
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Initial Treatment
Participants receive either Clinician Supported PTSD Coach App or Prolonged Exposure for Primary Care (PE-PC) for four weekly sessions or up to 9 weeks
4-9 weeks
4 weekly sessions
Adaptive Treatment
Based on response, participants either continue with the initial treatment or switch to a different therapy for 8 weeks
8 weeks
Weekly or bi-weekly sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Participant Groups
The study tests a stepped-care talk therapy model for PTSD patients by starting them on different therapies and potentially switching after four sessions based on their response. It compares beginning with either Clinician Supported PTSD Coach App or Prolonged Exposure for Primary Care (PE-PC), and then possibly moving to Full Prolonged Exposure.
6Treatment groups
Experimental Treatment
Group I: Prolonged Exposure for Primary Care (PE-PC) then full PEExperimental Treatment2 Interventions
PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.
Group II: Prolonged Exposure for Primary Care (PE-PC) then continued PE-PCExperimental Treatment1 Intervention
PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to continue with PE-PC (medium intensity) will continue weekly sessions for 8 weeks.
Group III: Prolonged Exposure for Primary Care (PE-PC) then continue as early responderExperimental Treatment1 Intervention
PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage (for 8 weeks).
Group IV: Clinician Supported PTSD Coach App then full PEExperimental Treatment2 Interventions
During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.
Group V: Clinician Supported PTSD Coach App then continued CS PTSD Coach AppExperimental Treatment1 Intervention
During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to continue this treatment will have the frequency reduced to twice monthly.
Group VI: Clinician Supported (CS) PTSD Coach App then continue as early responderExperimental Treatment1 Intervention
During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first). Early responders will be encouraged to continue app use but will discontinue clinician support sessions for 8 weeks.
Full Prolonged Exposure is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Prolonged Exposure for:
- Posttraumatic Stress Disorder (PTSD)
🇪🇺 Approved in European Union as Prolonged Exposure for:
- Posttraumatic Stress Disorder (PTSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Upper Great Lakes Family Health Care CenterMenominee, MI
Genesee Community Health CenterFlint, MI
Family Care Health CentersSaint Louis, MO
Grace HealthBattle Creek, MI
More Trial Locations
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]Prolonged exposure therapy (PE) is an evidence-based treatment for posttraumatic stress disorder (PTSD) that is underutilized in the military health system. Standard workshop training in PE may not be sufficient to alter provider behavior, but post-workshop consultation requires significant resources. Therefore, it is important to determine the incremental utility of post-workshop consultation.
Treatment of posttraumatic stress disorder with prolonged exposure for primary care (PE-PC): Effectiveness and patient and therapist factors related to symptom change and retention. [2023]Prolonged exposure (PE) is a first-line treatment for posttraumatic stress disorder (PTSD) available in specialty mental health. PE for primary care (PE-PC) is a brief version of PE adapted for primary care mental health integration, composed of four-eight, 30-min sessions. Using retrospective data of PE-PC training cases from 155 Veterans Health Administration (VHA) providers in 99 VHA clinics who participated in a 4- to 6-month PE-PC training and consultation program, we examined patients' PTSD and depression severity across sessions via mixed effects multilevel linear modeling. Additionally, hierarchical logistic regression analysis was conducted to assess predictors of treatment dropout. Among 737 veterans, medium-to-large reductions in PTSD (intent-to-treat, Cohen's d = 0.63; completers, Cohen's d = 0.79) and small-to-medium reductions in depression (intent-to-treat, Cohen's d = 0.40; completers, Cohen's d = 0.51) were observed. The modal number of PE-PC sessions was five (SD = 1.98). Providers previously trained in both PE and cognitive processing therapy (CPT) were more likely than providers who were not trained in either PE or CPT to have veterans complete PE-PC (OR = 1.54). Veterans with military sexual trauma were less likely to complete PE-PC than veterans with combat trauma (OR = 0.42). Asian American and Pacific Islander veterans were more likely than White veterans to complete treatment (OR = 2.93). Older veterans were more likely than younger veterans to complete treatment (OR = 1.11). (PsycInfo Database Record (c) 2023 APA, all rights reserved).
The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. [2022]Prolonged exposure (PE) therapy is a first-line posttraumatic stress disorder (PTSD) treatment, but the manualized 90-min session format constitutes a barrier to adopting PE in most settings because they use 60-min sessions for scheduling and billing. We examined whether 60-min PE sessions were as effective and efficient as 90-min PE sessions.
Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. [2021]Prolonged exposure (PE) therapy is an evidence-based psychological treatment of post-traumatic stress disorder (PTSD), yet uptake amongst practitioners is less than desirable. The aim of this study was to evaluate the efficacy of a PE training workshop plus intensive consultation programme to improve practitioners' self-efficacy and outcome expectations as well as uptake of PE for emergency service patients with PTSD.
Expanding the Reach of Effective PTSD Treatment Into Primary Care: Prolonged Exposure for Primary Care. [2020]Posttraumatic stress disorder (PTSD) is a costly mental health issue in the United States and throughout the world. Effective treatments are available; however, most people with PTSD never access these treatments. Prolonged exposure (PE) therapy has emerged as an effective, first-line treatment for PTSD and is provided in specialty mental health in eight to 15 sessions, each lasting 90 minutes. Most people with PTSD do not enter specialty mental health to access this service. Over the past 15 years, provision of mental health care in primary care has increased due to patient preference for care in this setting and the ability to overcome many access barriers (stigma, longer sessions, insurance coverage, etc.). While medications for PTSD are available in primary care, effective brief psychotherapeutic PTSD treatment options have only recently been established. PE-PC (prolonged exposure for primary care) is a brief version of PE therapy for PTSD with efficacy in a primary care (PC) setting in reducing PTSD, depression, and related mental disorder symptoms. PE-PC has four 30-minute sessions and focuses on imaginal exposure to the trauma memory, in vivo exposure to trauma-related avoidance, and emotional processing of the memory. Dissemination efforts are currently underway to expand availability.
Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. [2021]Prolonged exposure (PE) therapy is the first-line treatment for posttraumatic stress disorder (PTSD) in combat veterans. The underlying brain changes of treatment effect in PTSD are currently unknown.