Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Sponsor

Florida State University (Other)

Overall Status

Completed

CT.gov ID

NCT05700578

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Condition or Disease	Intervention/Treatment	Phase
PTSD	Behavioral: Safety Behavior Elimination for Traumatic Stress (SBETS) Behavioral: Modifiable Behavior Intervention (MoBI)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants were randomly assigned to complete one of two web based interventionsParticipants were randomly assigned to complete one of two web based interventions

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Actual Study Start Date :

Feb 27, 2022

Actual Primary Completion Date :

Nov 14, 2022

Actual Study Completion Date :

Nov 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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.
Active Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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

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.

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anxiety and Behavioral Health Clinic	Tallahassee	Florida	United States	32304

Sponsors and Collaborators

Florida State University

Investigators

Principal Investigator: Norman B Schmidt, Florida State University

Study Documents (Full-Text)

Informed Consent Form - Sep 23, 2022

More Information

Publications

None provided.

Responsible Party:

Carter Bedford, Graduate Research Assistant, Florida State University

ClinicalTrials.gov Identifier:

NCT05700578

Other Study ID Numbers:

STUDY00002835

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carter Bedford, Graduate Research Assistant, Florida State University

Psychoeducation

Online Intervention

Study Results

No Results Posted as of Jan 26, 2023