PTSDNCT05700578
Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
A study testing Safety Behavior Elimination for Traumatic Stress (SBETS) and Modifiable Behavior Intervention (MoBI) in people with PTSD, run by Florida State University at 1 site in United States.
Trial summary
Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- PTSD
- What is being tested?
- Safety Behavior Elimination for Traumatic Stress (SBETS) and Modifiable Behavior Intervention (MoBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2022to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women
- Adults unable to consent
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, 32304
About this study
Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
Read the 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.
- Conditions
- PTSD
- Being tested
- Safety Behavior Elimination for Traumatic Stress (SBETS), Modifiable Behavior Intervention (MoBI)
- Keywords
- Psychoeducation, Online Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Behavior Elimination for Traumatic Stress (SBETS)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Modifiable Behavior Intervention (MoBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 2 weeks, change from baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start27 Feb 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to complete one of two web based interventions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carter Bedford, Florida State University
- Investigators
- Norman B Schmidt, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700578
- Sponsor's protocol ID
- STUDY00002835
- Status last verified
- Mar 2023
- First submitted
- 17 Jan 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
- ClinicalTrials.gov ID
- NCT05700578
- Acronym / sponsor ID
- STUDY00002835
- Conditions
- PTSD
- Keywords
- Psychoeducation, Online Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to complete one of two web based interventions
| Arm | Type | Receives |
|---|---|---|
| Safety Behavior Elimination for Traumatic Stress (SBETS) | Experimental | Behavioral: 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 |
| Modifiable Behavior Intervention (MoBI) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant women
- Adults unable to consent
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Safety Behavior Elimination for Traumatic Stress (SBETS) |
| 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. | Behavioural | Modifiable Behavior Intervention (MoBI) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman B Schmidt principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Behavior Elimination for Traumatic Stress (SBETS) and Modifiable Behavior Intervention (MoBI) in people with PTSD, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Change from baseline to 2 weeks, change from baseline to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.