Posttraumatic Stress DisorderNCT03337750
An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military
A study testing Web-PE Therapy in people with Posttraumatic Stress Disorder and Combat Disorders, run by University of Pennsylvania at 2 sites in United States.
Trial summary
It is urgent to make evidence-based treatments (EBTs) for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for posttraumatic stress disorder (PTSD) in a timely manner. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Combat Disorders
- What is being tested?
- Web-PE Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2018to 14 Feb 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active-duty military personnel and veterans who have deployed post 9/11
- Seeking treatment for PTSD
- Significant PTSD symptoms as determined by a PCL-5 score greater than or equal to 31
- Has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a period of recent military deployment
- Able to speak and read English and access to an internet-connected computer
- Indication that the participant plans to be able to participant in the study for the next three months following the first assessment
Who cannot join
- Diagnosis of bipolar disorder or psychotic disorder, as determined by participant self-report)
- Current substance dependence, as determined by participant self-report)
- Diagnosis of a moderate or severe traumatic brain injury, as determined by participant self-report)
- Current suicidal ideation severe enough to warrant immediate attention, as determined by participant self-report)
- Currently engaged in evidence-based treatment for PTSD (e.g. Prolonged Exposure Therapy or Cognitive Processing Therapy), as determined by participant self-report.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for the Treatment and Study of Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
It is urgent to make evidence-based treatments (EBTs) for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are available, but barriers to accessing care can deter military personnel from receiving treatment. Web-treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-treatments for PTSD appear promising, however, they are not based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-treatment of PTSD using a well-established treatment program.
The purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks in 40 active-duty military personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment and 1- and 3-months after treatment completion.
- Conditions
- Posttraumatic Stress Disorder, Combat Disorders
- Being tested
- Web-PE Therapy
- Keywords
- Combat, Psychological Treatment, Military, Psychotherapy, Trauma, Posttraumatic Stress, Posttraumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-PE TherapyBehavioural
Also called Internet-based prolonged exposure
Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).
| Study group | Role | What they receive |
|---|---|---|
| Web-PE | Experimental | Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD). Receives: Behavioral: Web-PE Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD CheckList-5 (PCL-5)
A 20-item self-report measure of PTSD symptoms as defined by the DSM-5. Higher scores indicate greater PTSD symptom severity.
Measured: Change from baseline to 1-month follow-up (post-treatment)
Secondary outcomes (1)
Patient Health Questionnaire-9 (PHQ-9)
A 9-item measure of the severity of depressive symptoms. Higher scores indicated greater depressive symptom severity.
Measured: Change from baseline to 1-month follow-up (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start12 Feb 2018
- Primary completion27 Mar 2019
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Carmen McLean, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337750
- Sponsor's protocol ID
- HSC20170600H
- Status last verified
- Feb 2020
- First submitted
- 3 Nov 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Trial of Web-Prolonged Exposure (Web-PE) Among Active-Duty Military
- ClinicalTrials.gov ID
- NCT03337750
- Acronym / sponsor ID
- HSC20170600H
- Conditions
- Posttraumatic Stress Disorder, Combat Disorders
- Keywords
- Combat, Psychological Treatment, Military, Psychotherapy, Trauma, Posttraumatic Stress, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of Texas, VA Palo Alto Health Care System
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 9 Nov 2017 (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.
It is urgent to make evidence-based treatments (EBTs) for military personnel readily accessible in order to meet the growing demand for effective and efficient treatment for posttraumatic stress disorder (PTSD) in a timely manner. Effective EBTs for PTSD are available, but barriers to accessing care can deter military personnel from receiving treatment. Web-treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-treatments for PTSD appear promising, however, they are not based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-treatment of PTSD using a well-established treatment program.
The purpose of this open trial is to examine the efficacy of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks in 40 active-duty military personnel and veterans with PTSD who deployed post 9-11. Up to 60 individuals will be consented to obtain data from 40 for analysis. Participants will be assessed at pre-treatment and 1- and 3-months after treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-PE | Experimental | Behavioral: Web-PE TherapyTen 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active-duty military personnel and veterans who have deployed post 9/11
- Seeking treatment for PTSD
- Significant PTSD symptoms as determined by a PCL-5 score greater than or equal to 31
- Has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a period of recent military deployment
- Able to speak and read English and access to an internet-connected computer
Key exclusion criteria (5 listed)
- Diagnosis of bipolar disorder or psychotic disorder, as determined by participant self-report)
- Current substance dependence, as determined by participant self-report)
- Diagnosis of a moderate or severe traumatic brain injury, as determined by participant self-report)
- Current suicidal ideation severe enough to warrant immediate attention, as determined by participant self-report)
- Currently engaged in evidence-based treatment for PTSD (e.g. Prolonged Exposure Therapy or Cognitive Processing Therapy), as determined by participant self-report.
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 |
|---|---|---|
| Web-PE TherapyAlso: Internet-based prolonged exposureTen 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD). | Behavioural | Web-PE |
Primary outcome
PTSD CheckList-5 (PCL-5)
Time frame: Change from baseline to 1-month follow-up (post-treatment)
A 20-item self-report measure of PTSD symptoms as defined by the DSM-5. Higher scores indicate greater PTSD symptom severity.
1 secondary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline to 1-month follow-up (post-treatment)
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 19 Feb 2020.
- Study enrollment pageLink provided by the sponsor.
- STRONG STAR consortiumLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-PE Therapy in people with Posttraumatic Stress Disorder and Combat Disorders, run by University of Pennsylvania at 2 sites 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 6 inclusion and 5 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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-5 (PCL-5) (time frame: Change from baseline to 1-month follow-up (post-treatment)). 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 19 Feb 2020.