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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called Brief Prolonged Exposure to assist individuals with PTSD (posttraumatic stress disorder) following a spinal cord injury. The goal is to determine if this therapy reduces stress more effectively than the usual care provided during rehabilitation. Participants will receive either the new therapy or the standard treatment, and researchers will monitor their progress over several months. Individuals who have experienced a spinal cord injury due to a traumatic event and are currently in inpatient rehabilitation may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance PTSD treatment for future patients.

Will I have to stop taking my current medications?

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

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

Research has shown that Brief Prolonged Exposure (PE) Therapy is a well-studied treatment for post-traumatic stress disorder (PTSD). Studies have found it effectively reduces PTSD symptoms in various groups, including individuals with spinal cord injuries. This therapy involves safely confronting trauma memories, which can help reduce distress over time.

While specific safety details for Brief PE in this setting aren't provided, prolonged exposure therapies are generally considered safe and well-tolerated by most people. Conducted under professional supervision, these therapies ensure participants feel comfortable and safe. Participants may experience some distress during sessions, but this is normal and part of the healing process. Overall, research supports the safety and effectiveness of Brief PE for treating PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Prolonged Exposure therapy for PTSD after spinal cord injury because it offers a targeted approach to trauma recovery that's different from standard treatments. Unlike typical care, which often involves medication and traditional talk therapy, this method focuses on confronting trauma through controlled, repeated exposure to trauma memories, combined with education and breathing techniques. This approach not only addresses the psychological impact of trauma directly but also does so in a condensed timeframe, with just three sessions needed, potentially leading to quicker and more efficient recovery.

What evidence suggests that Brief Prolonged Exposure Therapy could be effective for PTSD after spinal cord injury?

Research shows that Brief Prolonged Exposure Therapy (Brief PE), which participants in this trial may receive, is a promising treatment for PTSD. A recent review of studies found it to be the best short-term early treatment for preventing PTSD symptoms. Prolonged Exposure Therapy (PE) has undergone extensive research and has proven very effective for PTSD in various situations, including for individuals with spinal cord injuries. In one study, veterans with PTSD improved after receiving PE, suggesting that Brief PE could help reduce PTSD symptoms in people with spinal cord injuries. Meanwhile, participants in the Treatment as Usual group will receive the standard clinical treatment for spinal cord injury at the rehabilitation facility. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark B Powers, PhD

Principal Investigator

Baylor Scott and White Research Institute-Trauma

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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

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Prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD. However, no trauma focused exposure-based therapy for PTSD (eg PE ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2451865422001478

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A recent meta-analysis [42] showed that the most effective brief early intervention to prevent PTSD was Modified Brief Prolonged Exposure Therapy (Brief PE) ...

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We conducted the first randomized controlled trial (RCT) of an evidence-based psychotherapy (prolonged exposure [PE]) with survivors of SCI during acute ...

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In an RCT of 916 veterans randomized to PE or another trauma focused treatment, Cognitive Processing Therapy (CPT), PTSD symptoms improved in both treatments.

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Purpose/Objective: Individuals with a spinal cord injury (SCI) may experience posttraumatic stress disorder (PTSD) at a higher rate, ...

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Study protocol for a randomized controlled trial of Brief ...

Article describes the protocol for a study that will assess the ability of the Brief Prolonged Exposure Therapy (PE) intervention to prevent ...