Stepped Care for Post-Traumatic Stress Disorder

(STEPPS Trial)

Overseen By Sarah Valentine, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Psychotropic

Disqualifiers: Current therapy, Acute suicide risk, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment options for people with PTSD by testing a flexible approach that combines digital and in-person therapies. Participants begin with a digital program called webSTAIR, and based on their response, some may receive additional treatments like Written Exposure Therapy (WET) or Brief STAIR. The goal is to provide more accessible and adaptable care for PTSD. This trial may suit those who have experienced trauma, have a PTSD diagnosis, and are stable on medication but are not currently receiving therapy. As an unphased trial, it offers participants the opportunity to contribute to innovative PTSD treatment strategies.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their current psychotropic medications for more than 4 weeks, so you will not need to stop taking them.

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

Research has shown that webSTAIR is generally safe and effective for individuals with PTSD. Studies have found improvements in PTSD and depression symptoms, as well as enhanced emotional control and social interactions in veterans. These findings indicate that the treatment is safe, with no major reports of negative side effects.

When combined with coaching, webSTAIR increases user satisfaction and further reduces PTSD and depression symptoms. No specific safety concerns have been reported for this combination, suggesting it is likely safe.

Overall, both webSTAIR and webSTAIR with coaching appear to be safe and beneficial options for managing PTSD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about webSTAIR for PTSD because it offers a flexible, stepped-care approach, starting with a digital mental health intervention that can be accessed online, making it more convenient and accessible than traditional in-person therapy. This digital format is combined with the option of community health worker coaching, providing personalized support that isn't typically available with standard PTSD treatments like cognitive processing therapy or prolonged exposure. Additionally, the trial is designed to adapt treatment based on a patient's response, adding trauma-focused or skills-focused therapy only if needed, which could lead to more efficient, individualized care.

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

Studies have shown that webSTAIR, one of the treatments in this trial, effectively reduces symptoms of PTSD and depression. It aids veterans in managing emotions and improving social lives. In this trial, some participants will receive webSTAIR with additional coaching, which research indicates can enhance these benefits, leading to better symptom relief and improved social interactions. Participants have found webSTAIR both satisfying and effective. Overall, webSTAIR, with or without coaching, has shown promising results for people with PTSD. ^{2 3 5 6 7}

Who Is on the Research Team?

Sarah Valentine, PhD

Principal Investigator

Boston Medical Center, Psychiatry

Are You a Good Fit for This Trial?

This trial is for individuals with PTSD, particularly those in low-income and racially diverse primary care settings where treatment rates are low. Participants should be willing to engage with digital mental health interventions and brief trauma-focused treatments.

Inclusion Criteria

I have been on stable mental health medication for over 4 weeks.

Assessed at pre-screening: Access to computer or mobile device

Assessed at pre-screening: Boston Medical Center primary care patient

Exclusion Criteria

Assessed at baseline (clinician interview): Patient is not clinically appropriate for outpatient level of care

I am currently receiving treatment from a healthcare professional.

I have been evaluated for suicide risk using a specific scale.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive access to webSTAIR, a digital mental health intervention, at baseline

4 weeks

1 visit (virtual)

Stage 1 Treatment

Nonresponders are randomized to continue webSTAIR or add community health worker coaching

4 weeks

1 visit (virtual)

Stage 2 Treatment

Nonresponders are re-randomized to either Brief STAIR or Written Exposure Therapy (WET)

10 weeks

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Clinician administered Brief STAIR
• Clinician administered WET
• webSTAIR
• WebSTAIR plus coaching

Trial Overview The study tests a stepped care approach for PTSD, starting with a digital intervention called webSTAIR, possibly adding coaching, followed by clinician-administered therapies like Brief STAIR or Written Exposure Therapy (WET), depending on the patient's response.

How Is the Trial Designed?

Group I: webSTAIR, webSTAIR to WET Active Control 2 Interventions

First, offer skills-focused digital mental health intervention (DMHI); then switch to clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.

Group II: webSTAIR+coaching, webSTAIR+coaching to WET Active Control 2 Interventions

First, offer skills-focused DMHI plus community health worker (CHW) coaching; then add clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders.

Group III: webSTAIR, webSTAIR to Brief STAIR Active Control 2 Interventions

First, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.

Group IV: webSTAIR+coaching, websTAIR+coaching to Brief STAIR Active Control 2 Interventions

First, offer skills-focused DMHI plus CHW coaching; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

Adverse events (AEs) in healthcare are common, occurring in about 10% of cases, and can have significant emotional impacts not only on patients but also on the healthcare professionals involved, who may experience trauma as 'second victims'.

Implementing Critical Incident Stress Debriefing (CISD) for healthcare staff after AEs could be a valuable strategy to support their resilience and recovery, similar to its use in other high-stress professions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical incident stress debriefing after adverse patient safety events. Harrison, R., Wu, A.[2018]

The study developed a stepped collaborative care intervention for PTSD, involving 207 acutely injured trauma survivors, which integrated care management with cognitive behavioral therapy and pharmacotherapy.

This approach was successfully implemented by social work and nurse practitioner providers in acute care settings, suggesting that it can effectively extend early trauma-focused interventions to a broader population of trauma survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the population impact of collaborative care interventions: mixed method development and implementation of stepped care targeting posttraumatic stress disorder and related comorbidities after acute trauma. Zatzick, D., Rivara, F., Jurkovich, G., et al.[2023]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

In a study of 2,643 veterans receiving treatment for PTSD, 25.9% experienced substantial improvement in symptoms, while 74.1% showed modest improvement, indicating that significant progress is possible in routine clinical practice.

The only strong predictor of substantial improvement was gender, with men having lower odds of achieving significant symptom reduction compared to women, suggesting that treatment approaches may need to be tailored based on gender differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using patient-reported outcomes to understand the effectiveness of guideline-concordant care for post-traumatic stress disorder in clinical practice. Shiner, B., Gui, J., Leonard Westgate, C., et al.[2023]

In a study of 193 pediatric patients with severe traumatic brain injury (sTBI), 53% experienced at least one adverse event (AE), highlighting the high risk of complications in this vulnerable population.

The most common AE was decubitus ulcers, and patients with AEs had longer hospital stays and higher costs, indicating that identifying and preventing AEs can improve patient safety and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. Charyk Stewart, T., Luong, K., Alharfi, I., et al.[2021]

Citations

1. academic.oup.com academic.oup.com/milmed/article/189/7-8/e1403/7619615

Preliminary Investigation Into the Effectiveness of Group ... This pilot study assessed the potential benefits of webSTAIR, a 10-module transdiagnostic treatment for trauma-exposed individuals, supported by 5 biweekly ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38442368/

Preliminary Investigation Into the Effectiveness of Group ... This pilot study assessed the potential benefits of webSTAIR, a 10-module transdiagnostic treatment for trauma-exposed individuals, supported by 5 biweekly ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06431022

Web-administered STAIR for Patients on Behavioral Health ... The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education ( ...

4. jmir.org jmir.org/2024/1/e52130/

Brief Peer-Supported Web-Based Skills Training in ... BPS webSTAIR was effective in improving PTSD and depression symptoms, emotion regulation, and psychosocial functioning in community veterans.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527289/

Study protocol for a hybrid 1 effectiveness-implementation ... This study will provide evidence for the feasibility, acceptability, and preliminary effectiveness of brief, low-intensity interventions in safety net ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11190026/

A prognostic index to predict symptom and functional ... This suggests that baseline symptom severity and functioning are strong indicators for webSTAIR outcomes in veterans, with higher severity indicating worse ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468749924001169

Skills training in affective and interpersonal regulation ... In a review of seven studies, STAIR therapy for CPTSD showed significant symptom reduction, with effect sizes ranging from d = 1.34 to 2.29 in clinician ...