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

428 Participants Needed

Trial Summary

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.

What data supports the effectiveness of this treatment for PTSD?

Research shows that stepped care models, which involve gradually increasing the intensity of treatment, can be effective for mental health conditions like PTSD. These models help by providing the right level of care at the right time, which can improve mental health and functioning in patients who have experienced trauma. ^{1 2 3 4 5}

Is the Stepped Care treatment for PTSD safe for humans?

The research articles reviewed do not provide specific safety data for the Stepped Care treatment for PTSD or its related interventions like Brief STAIR, WET, or webSTAIR. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How is the treatment webSTAIR for PTSD different from other treatments?

The webSTAIR treatment for PTSD is unique because it uses a stepped care approach, which means it provides different levels of care based on the patient's needs, making it more accessible and potentially more cost-effective compared to traditional treatments. ^{1 5 11 12 13}

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) prevalence can be as high as 50% in low income and racially diverse primary care clinics, wherein only 13% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable, less burdensome to systems of care, and highly acceptable to diverse patients and care settings. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).

Research Team

Sarah Valentine, PhD

Principal Investigator

Boston Medical Center, Psychiatry

Eligibility Criteria

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

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

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

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

Exclusion Criteria

I am currently receiving treatment from a healthcare professional.

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

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

A randomized stepped care intervention trial targeting posttraumatic stress disorder for surgically hospitalized injury survivors. [2021]

2. England 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A proof-of-concept randomized controlled trial of follow-up mental health care for traumatic injury patients following hospital discharge. [2023]

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

Screening and treating hospitalized trauma survivors for posttraumatic stress disorder and depression. [2020]

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

Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. [2023]

6. Netherlands 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. [2021]

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

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

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

Critical incident stress debriefing after adverse patient safety events. [2018]

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

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]

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

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of Stepped Care Psychological Prevention and Treatment Approaches for Posttraumatic Stress Disorder. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Child and parent secondary outcomes in stepped care versus standard care treatment for childhood trauma. [2023]

13. United States 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. [2023]