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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05233111
Other study ID # 021-339
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2022
Est. completion date August 2026

Study information

Verified date December 2021
Source Baylor Research Institute
Contact Neil M Stewart
Phone 2148205843
Email neil.stewart@bswhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered in an inpatient rehabilitation setting post-SCI to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after SCI and to mitigate long-term post-SCI distress including PTSD as well as secondary health outcomes (including depression and general anxiety) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event Exclusion Criteria: - Patients in police custody - Not fluent in the English language - Severe cognitive impairment - Patients who are acutely suicidal - Patients with active psychosis

Study Design


Intervention

Behavioral:
Brief Prolonged Exposure Therapy
Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.
Treatment as Usual
This may include an evaluation by a licensed psychologist and continued follow-up psychotherapy as needed. Treatment as usual participants will have follow-up assessments at 1, 3, and 6 months.

Locations

Country Name City State
United States Baylor Institute for Rehabilitation Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor Research Institute National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5 Change in PTSD symptoms from baseline to 6 months. Total scale ranges from 0-80 points. Higher score indicates greater severity of symptoms. Baseline, 1 month, 3 months ,6 months
Secondary Change in Patient Health Questionnaire-9 Change in depressed mood from baseline to 6 months. Scored on a 0-27 scale. Higher score indicates greater severity of issues. Baseline, 1 month, 3 months ,6 months
Secondary Change in Generalized Anxiety Disorder-7 Item Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety. Time Frame: Baseline, 1 month, 3 months, 6 months
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