Prolonged Exposure Therapy for PTSD After Spinal Cord Injury

Overseen By Neil M Stewart

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Police custody, Non-English, Cognitive impairment, others

Compensation: Varies

Number of Visits: 6

Duration: 2-3 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine the use brief prolonged exposure (Brief PE) therapy compared to standard clinical care to reduce posttraumatic distress among people who have had a spinal cord injury and are receiving rehabilitation in an inpatient setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for PTSD after spinal cord injury?

Prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD, and recent clinical trials have shown that standard 12-session PE is effective for treating PTSD among inpatients with spinal cord injury (SCI). Additionally, early intervention with a brief version of PE has been effective for PTSD prevention in other settings, suggesting potential benefits for SCI patients. ^{1 2 3 4 5}

Is prolonged exposure therapy safe for humans?

Prolonged exposure therapy (PE) is a well-researched treatment for PTSD and is generally considered safe for humans. While some clinicians worry it might worsen symptoms, it is widely used and studied, showing it is safe for many people. ^{1 2 3 5 6}

How is Brief Prolonged Exposure Therapy different from other treatments for PTSD after spinal cord injury?

Brief Prolonged Exposure Therapy is unique because it involves a shorter, 3-session format designed to prevent PTSD in patients with spinal cord injuries, whereas traditional prolonged exposure therapy typically involves 12 sessions. This approach is novel as it aims to provide early intervention in a more condensed timeframe, potentially making it more accessible and feasible for patients during their initial recovery phase. ^{1 3 4 5 7}

Research Team

Mark B Powers, PhD

Principal Investigator

Baylor Scott and White Research Institute-Trauma

Eligibility Criteria

This trial is for adults over 18 who have experienced a traumatic spinal cord injury and are currently in an inpatient rehabilitation hospital. It's designed to help those struggling with posttraumatic stress as a result of their injury.

Inclusion Criteria

I am in rehab for a spinal cord injury from an accident.

I am 18 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive Brief Prolonged Exposure Therapy with three 60-minute sessions spaced 1-7 days apart

2-3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for psychological distress and secondary health outcomes at 1, 3, and 6 months from baseline

6 months

3 visits (in-person or virtual)

Treatment Details

Interventions

• Brief Prolonged Exposure Therapy
• Treatment as Usual

Trial Overview The study is testing Brief Prolonged Exposure (Brief PE) therapy against the standard treatment typically given for posttraumatic stress in patients with spinal cord injuries during their rehab stay.

Participant Groups

Group I: Brief Prolonged Exposure Experimental Treatment 1 Intervention

Experimental: Brief Prolonged Exposure Participants will receive Brief PE. Subjects in the Brief Prolonged Exposure (BPE) intervention group will additionally receive 3 total therapy sessions, each lasting about 60 minutes spaced about 1-7 days apart. Sessions include education about common reactions to trauma, breathing retraining, identification of self-care tasks and prolonged (repeated) imaginal exposure to trauma memories. Any missed sessions will be made up by scheduling multiple sessions in subsequent weeks. Individuals in the BPE group will complete a screener and then survey questionnaires/ interviews at 1, 3, and 6 months from Baseline.

Group II: Treatment as Usual Placebo Group 1 Intervention

Participants in the Treatment as Usual (TAU) group will not receive Prolonged Exposure therapy, but will instead receive the standard clinical treatment received by all persons with spinal cord injury (SCI) at the rehabilitation facility. TAU participants will complete questionnaires/interviews at 1, 3, and 6 months from Baseline.

Brief Prolonged Exposure Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Post-traumatic stress disorder (PTSD)
• Depression
• Anxiety
• Anger

Approved in European Union as Prolonged Exposure Therapy for:

• Post-traumatic stress disorder (PTSD)
• Depression
• Anxiety
• Anger

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Findings from Research

Up to 60% of individuals with spinal cord injury (SCI) may experience posttraumatic stress disorder (PTSD), highlighting a significant psychological issue in this population that is often overlooked.

This study will be the first to test prolonged exposure therapy (PE), a proven treatment for PTSD, in a group of 60 adults with SCI, comparing its effectiveness to standard rehabilitation care over a period of 32 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial. Powers, MB., Pogue, JR., Curcio, NE., et al.[2021]

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]

This study will test the effectiveness of a 3-session Brief Prolonged Exposure (PE) therapy for preventing PTSD in 200 adults with spinal cord injury (SCI), building on previous research that shows standard PE is effective for PTSD treatment.

The outcomes will be measured using the PSSI-5 for PTSD symptoms and will also assess depression, anxiety, and quality of life over 6 months, aiming to establish a new evidence-based intervention for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of posttraumatic stress during inpatient rehabilitation post spinal cord injury: Study protocol for a randomized controlled trial of Brief Prolonged Exposure Therapy (Brief PE). Powers, MB., Douglas, ME., Driver, S., et al.[2022]

Prolonged Exposure (PE) therapy is a safe and effective treatment for PTSD, with a study of 361 female assault survivors showing no reliable worsening of PTSD symptoms and low rates of depression worsening among those who received PE.

Participants receiving PE and other active treatments demonstrated significant improvements in PTSD and depression compared to those on a waitlist, highlighting the importance of treatment in preventing symptom deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primum non nocere (first do no harm): symptom worsening and improvement in female assault victims after prolonged exposure for PTSD. Jayawickreme, N., Cahill, SP., Riggs, DS., et al.[2014]

A needs assessment across eight military treatment facilities identified consistent organizational barriers to implementing prolonged exposure therapy for PTSD, including time constraints, provider issues, patient education challenges, and scheduling difficulties.

The study provides tailored potential solutions for each identified barrier, aiming to enhance the use of this effective therapy within the military health system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Potential Solutions to Implementing Evidence-Based PTSD Treatment in Military Treatment Facilities. McLean, CP., Cook, J., Riggs, DS., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for PTSD among spinal cord injury survivors: Study protocol for a randomized controlled trial. [2021]

2. 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]

3. 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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Prevention of posttraumatic stress during inpatient rehabilitation post spinal cord injury: Study protocol for a randomized controlled trial of Brief Prolonged Exposure Therapy (Brief PE). [2022]

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

Primum non nocere (first do no harm): symptom worsening and improvement in female assault victims after prolonged exposure for PTSD. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Barriers and Potential Solutions to Implementing Evidence-Based PTSD Treatment in Military Treatment Facilities. [2022]