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OpenTrials
Completed

NCT Number: NCT05700578

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Completed

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safety Behavior Elimination for Traumatic Stress (SBETS)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: 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.

  2. Posttraumatic Safety Behavior Questionnaire (PSBQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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