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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, PTSD, Post-Traumatic Stress Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief Prolonged Exposure Therapy

Treatment as Usual

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring PTSD, SCI, Spinal Cord Injury, Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Baylor Institute for RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Treatment as Usual

Brief Prolonged Exposure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Change in Generalized Anxiety Disorder-7 Item

Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety.

Full Information

NCT ID

NCT05233111

First Posted

January 14, 2022

Last Updated

February 15, 2022

Sponsor

Baylor Research Institute

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

1. Study Identification

Unique Protocol Identification Number

NCT05233111

Brief Title

Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury

Official Title

Prevention of Posttraumatic Stress: A RCT of Modified Brief Prolonged Exposure Therapy (Brief PE) During Inpatient Rehabilitation Post Spinal Cord Injury (SCI)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 7, 2022 (Actual)

Primary Completion Date

August 2026 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baylor Research Institute

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, PTSD, Post-Traumatic Stress Disorder

Keywords

PTSD, SCI, Spinal Cord Injury, Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment as Usual

Arm Type

Placebo Comparator

Arm Description

Arm Title

Brief Prolonged Exposure

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Brief Prolonged Exposure Therapy

Intervention Description

Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes.

Intervention Type

Behavioral

Intervention Name(s)

Treatment as Usual

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5

Description

Change in PTSD symptoms from baseline to 6 months. Total scale ranges from 0-80 points. Higher score indicates greater severity of symptoms.

Time Frame

Baseline, 1 month, 3 months ,6 months

Secondary Outcome Measure Information:

Title

Change in Patient Health Questionnaire-9

Description

Change in depressed mood from baseline to 6 months. Scored on a 0-27 scale. Higher score indicates greater severity of issues.

Time Frame

Baseline, 1 month, 3 months ,6 months

Title

Change in Generalized Anxiety Disorder-7 Item

Description

Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety.

Time Frame

Time Frame: Baseline, 1 month, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Neil M Stewart

Phone

2148205843

neil.stewart@bswhealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark B Powers, PhD

Organizational Affiliation

Baylor Scott and White Research Institute-Trauma

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baylor Institute for Rehabilitation

City

Dallas

State/Province

Texas

ZIP/Postal Code

75204

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Neil Stewart

Phone

214-820-5843

neil.stewart@bswhealth.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury

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