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)

Contemporary Clinical Trials Communications, 2022 · DOI: https://doi.org/10.1016/j.conctc.2022.101030 · Published: October 26, 2022

Spinal Cord Injury Mental Health

Simple Explanation

This research aims to study the effectiveness of Brief Prolonged Exposure (PE) therapy in preventing PTSD among individuals who have experienced a spinal cord injury (SCI). Brief PE involves three sessions of therapy focused on trauma memories and related anxiety. The study will compare a group receiving Brief PE to a control group receiving standard care, assessing PTSD symptoms, depression, anxiety, pain, quality of life, sleep, and resilience at different intervals. The goal is to provide an evidence-based program that alleviates post-traumatic distress and prevents the long-term development of PTSD after a spinal cord injury.

Study Duration

6 Months

Participants

200 adults with spinal cord injury

Evidence Level

Level 1, Randomized Controlled Trial Protocol

Key Findings

1
The primary outcome measure is PTSD symptoms measured by the PSSI-5 at baseline, 1-month, 3-months, and 6-months.
2
Secondary outcome measures include depression, anxiety, pain, quality of life, sleep disturbance, and resilience.
3
Hierarchical linear modeling (HLM) will be used to evaluate the effectiveness of the PE intervention on PTSD and secondary outcomes.

Research Summary

This study protocol outlines a randomized controlled trial to assess the efficacy of Brief Prolonged Exposure (PE) therapy in preventing posttraumatic stress disorder (PTSD) among individuals with spinal cord injuries (SCI) during inpatient rehabilitation. The trial will involve 200 adults with SCI, randomly assigned to either Brief PE or treatment as usual, with assessments at baseline, 1-month, 3-months, and 6-months. The primary outcome is PTSD symptoms, with secondary outcomes including depression, anxiety, pain, quality of life, sleep disturbance and resilience. Feasibility of delivering Brief PE in the inpatient rehabilitation setting will also be assessed.

Practical Implications

Clinical Practice

Successful completion of this study could lead to the implementation of Brief PE as a standard preventative intervention for PTSD in SCI rehabilitation programs.

Research

The study will contribute to the limited evidence base on PTSD treatment and prevention in the SCI population, potentially inspiring further research in this area.

Patient Outcomes

If effective, Brief PE could improve psychological well-being, reduce PTSD symptoms, and enhance overall quality of life for individuals with SCI.

Study Limitations

1
The Brief PE manual is currently only available in English and has only been tested in English.
2
Patients who are acutely suicidal may require a higher level of intervention than provided in this trial.
3
The study is being conducted at a single rehabilitation center, which may limit the generalizability of the findings.

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