Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Study Overview
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Brief Summary
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Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Detailed Description
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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.

Official Title
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Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Safety Behavior Elimination for Traumatic Stress (SBETS)
* Behavioral: Modifiable Behavior Intervention (MoBI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomly assigned to complete one of two web based interventions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety Behavior Elimination for Traumatic Stress (SBETS)<br>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)<br>* 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.<br>|
| Active Comparator: Modifiable Behavior Intervention (MoBI)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychoeducation, Online Intervention