Adaptive PTSD Interventions for PTSD

Recruiting at 11 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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 5 6}

How 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. ^{1 2 3 4 5}

Eligibility 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

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

Treatment Details

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.

Participant Groups

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 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 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+

Findings from Research

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States 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. [2023]

3. United States 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. [2022]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Expanding the Reach of Effective PTSD Treatment Into Primary Care: Prolonged Exposure for Primary Care. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. [2021]