NCT05700578

Brief Summary

Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

January 17, 2023

Last Update Submit

March 27, 2023

Conditions

PTSD

Keywords

PsychoeducationOnline Intervention

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Safety Behavior Elimination for Traumatic Stress (SBETS)

EXPERIMENTAL

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)

Modifiable Behavior Intervention (MoBI)

ACTIVE COMPARATOR

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)

Interventions

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.

Safety Behavior Elimination for Traumatic Stress (SBETS)
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.

Modifiable Behavior Intervention (MoBI)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women
  • Adults unable to consent
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32304, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Norman B Schmidt

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to complete one of two web based interventions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Research Assistant

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

February 27, 2022

Primary Completion

November 14, 2022

Study Completion

November 14, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

US(1)