Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Modifiable Behavior Intervention (MoBI); Behavioral: Safety Behavior Elimination for Traumatic Stress (SBETS)

• Registration Number: NCT05700578
• Lead Sponsor: Florida State University

Brief Summary

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Detailed Description

This study compared exposure to one of two web-based treatments in self-reported improvement of posttraumatic stress disorder (PTSD) symptoms in adults with at least one lifetime traumatic event and elevated posttraumatic stress symptoms.

Study Timeline

• Study Start: 2022-02-27
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• English-speaking individuals
• Experience of at least one lifetime traumatic event, as measured by the Life Events Checklist
• Score of 25 or higher on the PTSD Checklist for DSM-5

Exclusion Criteria

• Pregnant women
• Adults unable to consent
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modifiable Behavior Intervention (MoBI)	Modifiable Behavior Intervention (MoBI)	Web-Based Modifiable Behavior Intervention. (1) 30-minute session focused on providing psychoeducation about strategies to maintain one's physical and mental health, such as by exercising, maintaining a healthy diet, and managing stress.
Safety Behavior Elimination for Traumatic Stress (SBETS)	Safety Behavior Elimination for Traumatic Stress (SBETS)	Web-Based Safety Behavior Elimination for Traumatic Stress Intervention. (1) 30-minute session focused on providing psychoeducation about the nature of posttraumatic stress disorder (PTSD), how trauma-related safety behavior use worsens PTSD, and strategies to reduce or eliminate safety behavior use

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5)	Change from baseline to 2 weeks, change from baseline to 1 month	A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. 0-4 scale (0="Not at all", 1="A little bit", 2=" Moderately", 3="Quite a bit", and 4="Extremely.") A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items.
Posttraumatic Safety Behavior Questionnaire (PSBQ)	Change from baseline to 2 weeks, change from baseline to 1 month	A 23-item self-report measure assessing frequency of use of 23 trauma-related safety behaviors. 0-4 scale (0="Never", 1="Rarely", 2=" Sometimes", 3="Often", and 4="Always.") A total safety behavior use score (range - 0-92) can be obtained by summing the scores for each of the 23 items.

Trial Locations

Locations (1)

Anxiety and Behavioral Health Clinic; 🇺🇸 Tallahassee, Florida, United States