Adaptive PTSD Interventions for PTSD

Recruiting at 12 trial locations

Overseen By Kayla Longuski, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Severe cognitive impairment, High suicide risk, Severe alcohol or substance use, Active psychosis, Unmanaged bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

430 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to use talk therapy for people with PTSD. Researchers are testing whether starting with one type of therapy proves more effective than another and if switching therapies after a few sessions offers more benefits than continuing with the same one. The goal is to reduce PTSD symptoms while using resources wisely. Individuals dealing with PTSD who receive care at a federally qualified health center, own a mobile device, and have had stable medication for at least four weeks might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative PTSD treatment strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the Clinician Supported PTSD Coach App and Prolonged Exposure therapies are generally safe for treating PTSD.

Studies have found that the PTSD Coach App, when used with clinician support, effectively manages PTSD symptoms. The app is widely used, and no major safety issues have been reported. It combines self-help strategies with support from a mental health professional.

Prolonged Exposure therapy, including a version adapted for primary care (PE-PC), is a well-known treatment for PTSD. It involves discussing traumatic experiences in a safe environment to help reduce symptoms. Research indicates it is effective and well-tolerated by patients. Some studies note a dropout rate of about 18% for active PTSD treatments, which is common in therapy settings, though this rate can vary.

Overall, evidence supports that both approaches are safe and helpful for reducing PTSD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they offer adaptable and personalized care through innovative methods. Unlike traditional therapy, which often has a fixed structure, these new interventions, such as the Clinician Supported PTSD Coach App and Prolonged Exposure for Primary Care (PE-PC), allow for flexibility based on individual response. The use of technology, like the PTSD Coach App, provides continuous support and encourages daily practice, making therapy more accessible and less intimidating. Additionally, by integrating shorter, primary care-based sessions, these treatments aim to reach more individuals and potentially reduce therapy dropout rates, making treatment more effective and engaging.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Prolonged Exposure (PE) therapy, one treatment in this trial, effectively treats PTSD, with success rates between 65% and 80%. This therapy involves safely confronting trauma-related memories and situations, reducing symptoms over time. Another treatment, Prolonged Exposure for Primary Care (PE-PC), significantly reduces PTSD symptoms and moderately reduces depression. It adapts the full PE approach for primary care settings, improving accessibility. The Clinician-Supported PTSD Coach App, also under study in this trial, combines mental health support with a mobile app, potentially leading to greater reductions in PTSD symptoms and increased use of specialized PTSD care. These treatments have shown promise in helping people manage PTSD symptoms effectively. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Clinician Supported PTSD Coach App
• Full Prolonged Exposure
• Prolonged Exposure for Primary Care (PE-PC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Prolonged Exposure for Primary Care (PE-PC) then full PE Experimental Treatment 2 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 and 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-PC Experimental Treatment 1 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 responder Experimental Treatment 1 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 PE Experimental Treatment 2 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 App Experimental Treatment 1 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 responder Experimental Treatment 1 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 the remaining 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)

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Prolonged exposure therapy (PE) is a highly effective treatment for PTSD, but many individuals do not access it due to barriers in specialty mental health settings.

PE-PC, a brief version of PE therapy consisting of four 30-minute sessions, has been shown to effectively reduce PTSD and related symptoms in primary care, making it more accessible for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding the Reach of Effective PTSD Treatment Into Primary Care: Prolonged Exposure for Primary Care. Rauch, SAM., Cigrang, J., Austern, D., et al.[2020]

In a study of 31 combat veterans with PTSD undergoing prolonged exposure therapy, 9 out of 24 completers achieved complete remission from PTSD, indicating the therapy's potential efficacy.

The study found that successful remission from PTSD was associated with decreased activation in the left anterior insula during negative image anticipation and increased connectivity with other brain regions, suggesting that effective treatment may involve better regulation of anticipatory anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. Simmons, AN., Norman, SB., Spadoni, AD., et al.[2021]

Prolonged exposure therapy adapted for primary care (PE-PC) significantly reduced PTSD symptoms in veterans, with medium-to-large effect sizes observed (Cohen's d = 0.63 for intent-to-treat and d = 0.79 for completers) and small-to-medium reductions in depression (Cohen's d = 0.40 for intent-to-treat and d = 0.51 for completers).

Factors influencing treatment completion included prior training of providers in PE or cognitive processing therapy, with trained providers having a higher likelihood of veterans completing PE-PC (OR = 1.54), while veterans with military sexual trauma were less likely to complete treatment (OR = 0.42).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rauch, SAM., Venners, MR., Ragin, C., et al.[2023]

A study involving 160 active-duty military personnel with PTSD found that 60-minute prolonged exposure (PE) therapy sessions are just as effective as the standard 90-minute sessions, making treatment more accessible in settings that typically use shorter appointment times.

Both the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5) showed that the efficacy of 60-minute sessions was noninferior to 90-minute sessions, suggesting that shorter sessions can be effectively implemented without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. Foa, EB., Bredemeier, K., Acierno, R., et al.[2022]

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.

Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Foa, EB., McLean, CP., Brown, LA., et al.[2022]

A training workshop on prolonged exposure (PE) therapy for PTSD significantly improved the self-efficacy and outcome expectations of 45 psychologists, leading to increased use of PE techniques in their practice.

The study highlights the importance of combining training with intensive consultation to enhance the delivery of evidence-based PTSD treatments, suggesting that such approaches could help more emergency service patients receive effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. Wade, D., Terhaag, S., Putica, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10022983/

A Randomized Clinical Trial of Clinician-Supported PTSD ... CS PTSD Coach was designed to be implemented in Veterans Affairs PCMHI and combines mental health clinician support with the “PTSD Coach” mobile app.

2. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id44682.pdf

Using PTSD Coach in primary care with and ... Clinician-Supported PTSD Coach resulted in more specialty PTSD care use postintervention and possibly greater reductions in PTSD symptoms. Conclusions: Both ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02685358

NCT02685358 | An RCT of a Primary Care-Based PTSD ... In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36932268/

A Randomized Clinical Trial of Clinician-Supported PTSD ... Coach participants engaged in 74% more sessions in the intervention and reported higher treatment satisfaction than TAU participants (p < .001).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163834315002236

Using PTSD Coach in primary care with and without ... Clinician-Supported PTSD Coach resulted in more specialty PTSD care use postintervention and possibly greater reductions in PTSD symptoms. Conclusions. Both ...

6. ptsd.va.gov ptsd.va.gov/appvid/mobile/ptsdcoach_app.asp

PTSD Coach - PTSD: National Center for PTSD PTSD Coach is a free and publicly available mobile app for people with Posttraumatic Stress Disorder (PTSD) and those interested in learning more about PTSD.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02445196?cond=PTSD&rank=10&tab=results

Study Results | NCT02445196 | PTSD Coach App Evaluation PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD. Smartphone: All participants must have a ...

8. samhsa.gov samhsa.gov/resource/dbhis/ptsd-coach

PTSD Coach The PTSD Coach app can be used by individuals who believe they may be suffering from posttraumatic stress disorder (PTSD), as well as their ...