Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

NCT ID: NCT05700578

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-27

Study Completion Date

2022-11-14

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.

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned to complete one of two web based interventions
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Safety Behavior Elimination for Traumatic Stress (SBETS)

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Modifiable Behavior Intervention (MoBI)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Carter Bedford

Graduate Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman B Schmidt

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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Anxiety and Behavioral Health Clinic

Tallahassee, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY00002835

Identifier Type: -

Identifier Source: org_study_id

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