Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

PTSD Clinical Trial

Official title:

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05700578
• Other study ID #: STUDY00002835
• Status: Completed
• Phase: N/A
• Start date: February 27, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: March 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Safety Behavior Elimination for Traumatic Stress (SBETS)
This intervention took 30 minutes to complete. At the end of the intervention, participants were instructed to select two of their most commonly-used trauma-related safety behaviors to reduce or eliminate over the coming month.
• Modifiable Behavior Intervention (MoBI)
The intervention took 30 minutes to complete. At the end of the intervention, participants were instructed to select two of their most commonly-used unhealthy behaviors to reduce or eliminate over the coming month.

Locations

Country	Name	City	State
United States	Anxiety and Behavioral Health Clinic	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist for DSM-5 (PCL-5)	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.	Change from baseline to 2 weeks, change from baseline to 1 month
Primary	Posttraumatic Safety Behavior Questionnaire (PSBQ)	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.	Change from baseline to 2 weeks, change from baseline to 1 month