Posttraumatic Stress DisorderNCT02720497
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
A study testing 60-minute Prolonged Exposure Therapy and 90-minute Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder and Combat Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
Objectives and Rationale: With up to 20% of U.S. service members returning from Iraq and Afghanistan with PTSD symptoms, a critical need exists for treatments that are both effective and efficient, enabling the greatest number possible to be treated to remission. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Combat Disorder
- What is being tested?
- 60-minute Prolonged Exposure Therapy and 90-minute Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2021
- 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
- Adult male and female active duty military personnel who have deployed since 9/11, ages 18-65 seeking treatment for Posttraumatic Stress Disorder (PTSD).
- Either diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview, OR, CAPS-5 severity ≥ 25 and a PCL-5 score of ≥ 25.
- Able to speak, read, and write English.
Who cannot join
- Current manic or psychotic symptoms required immediate stabilization or hospitalization (as determined by the Manic and Psychosis sections of the Mini International Neuropsychiatric Interview; MINI)
- Current severe alcohol use symptoms (as determined by a score of ≥ 4 on items #4-6 and a total score of ≥ 20 on the Alcohol Use Disorders Identification Test; AUDIT).
- Evidence of a severe traumatic brain injury as determined by marked impairment in communication or comprehension.
- Current suicidal ideation severe enough to warrant immediate crisis intervention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD: A Randomized Controlled Trial in Active Duty Military Personnel
Objectives and Rationale: With up to 20% of U.S. service members returning from Iraq and Afghanistan with PTSD symptoms, a critical need exists for treatments that are both effective and efficient, enabling the greatest number possible to be treated to remission. As a highly efficacious treatment and the one with the most scientific support, Prolonged Exposure (PE) is recommended by the Institute of Medicine and being rolled out by the Departments of Defense and Veterans Affairs to help heal our war fighters' psychological wounds. A major barrier to that roll-out, however, is that PE is typically delivered in 90-minute sessions. This is difficult for military mental health providers, who because of large patient loads and pressure to see as many patients per day as possible, limit therapy sessions to 60 minutes. The primary aim of this randomized clinical trial is to determine whether PE sessions can be reduced to 60 minutes without compromising the treatment's high success rate. Preliminary evidence suggests that patients may greatly benefit from PE even when the time spent recalling and recounting the trauma memories during sessions (a key procedure called imaginal exposure) is shortened to fit into a 60-minute session. To test this hypothesis, the trial will enroll 160 San Antonio-area active duty service members who will be randomly assigned to receive PE treatment with 60- or 90-minute sessions. In an additional effort to learn more about how PE helps patients recover - and thereby gain insights to further enhance treatment benefit - the study investigators will examine what causes reductions in PTSD symptoms during PE by examining self-reported and physiological markers (e.g., heart rate reactivity) between the two treatment groups.
Research Applicability and Impact: If PE can be shown to maintain high success rates with shorter sessions, more military clinicians could offer this powerful therapy, as it would fit within time constraints of their heavy workload. This would potentially help thousands of our nation's warriors recover from the devastating psychological effects of PTSD and maintain their military careers, heal hurting relationships, and reengage in meaningful life activities. This study would further benefit the military and the general public by enhancing the readiness of our Armed Forces and reducing the public cost of service members' lost work time or veterans' disability benefits. Overloaded VA providers and even civilian therapists, who often limit sessions to 60 minutes due to insurance reimbursement requirements, may also be more likely to utilize the shorter treatment format, increasing access to evidence-base care for veterans and civilians. In addition, insights from the study's examination of biomarkers and underlying mechanisms of PE could be used to enhance care for service members, veterans, and the general public. Study risks are minimal, as a small proportion of patients may see temporary symptom increases as they deal with traumatic memories, but this is part of the recovery process. Patients receiving the shorter treatment sessions potentially may realize a lower level of treatment benefits, but preliminary evidence suggests there is good reason to believe their treatment will be equally as successful as those receiving traditional PE.
- Conditions
- Posttraumatic Stress Disorder, Combat Disorder
- Being tested
- 60-minute Prolonged Exposure Therapy, 90-minute Prolonged Exposure Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60-minute Prolonged Exposure TherapyBehavioural
This treatment condition is a modified version of Prolonged Exposure therapy for PTSD. It consists of weekly weekly 60-minute sessions, with 20 minutes imaginal exposure.
90-minute Prolonged Exposure TherapyBehavioural
Prolonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure.
| Study group | Role | What they receive |
|---|---|---|
| 60-minute Prolonged Exposure | Experimental | This treatment condition is a modified version of Prolonged Exposure therapy for PTSD. It consists of weekly weekly 60-minute sessions, with 20 minutes imaginal exposure. Receives: Behavioral: 60-minute Prolonged Exposure Therapy |
| 90-minute Prolonged Exposure | Active comparator | Prolonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure. Receives: Behavioral: 90-minute Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interviewer-assessed Posttraumatic Stress Disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for Diagnostic Statistical Manual (DSM)-5
Measured: Change from baseline to 1-month follow-up (post-treatment)
Secondary outcomes (1)
Self-reported Posttraumatic Stress Disorder (PTSD) symptoms Posttraumatic Stress Checklist for Diagnostic Statistical Manual (DSM)-5
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 posted28 Mar 2016 (estimated)
- Study startSep 2013
- Primary completionMar 2021
- Study completionMar 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Edna Foa, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720497
- Sponsor's protocol ID
- W81XWH-15-1-0555
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD: A Randomized Controlled Trial in Active Duty Military Personnel
- ClinicalTrials.gov ID
- NCT02720497
- Acronym / sponsor ID
- W81XWH-15-1-0555
- Conditions
- Posttraumatic Stress Disorder, Combat Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, U.S. Army Medical Research and Development Command
- Study start
- Sep 2013 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 28 Mar 2016 (estimated)
- 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.
Objectives and Rationale: With up to 20% of U.S. service members returning from Iraq and Afghanistan with PTSD symptoms, a critical need exists for treatments that are both effective and efficient, enabling the greatest number possible to be treated to remission. As a highly efficacious treatment and the one with the most scientific support, Prolonged Exposure (PE) is recommended by the Institute of Medicine and being rolled out by the Departments of Defense and Veterans Affairs to help heal our war fighters' psychological wounds. A major barrier to that roll-out, however, is that PE is typically delivered in 90-minute sessions. This is difficult for military mental health providers, who because of large patient loads and pressure to see as many patients per day as possible, limit therapy sessions to 60 minutes. The primary aim of this randomized clinical trial is to determine whether PE sessions can be reduced to 60 minutes without compromising the treatment's high success rate. Preliminary evidence suggests that patients may greatly benefit from PE even when the time spent recalling and recounting the trauma memories during sessions (a key procedure called imaginal exposure) is shortened to fit into a 60-minute session. To test this hypothesis, the trial will enroll 160 San Antonio-area active duty service members who will be randomly assigned to receive PE treatment with 60- or 90-minute sessions. In an additional effort to learn more about how PE helps patients recover - and thereby gain insights to further enhance treatment benefit - the study investigators will examine what causes reductions in PTSD symptoms during PE by examining self-reported and physiological markers (e.g., heart rate reactivity) between the two treatment groups.
Research Applicability and Impact: If PE can be shown to maintain high success rates with shorter sessions, more military clinicians could offer this powerful therapy, as it would fit within time constraints of their heavy workload. This would potentially help thousands of our nation's warriors recover from the devastating psychological effects of PTSD and maintain their military careers, heal hurting relationships, and reengage in meaningful life activities. This study would further benefit the military and the general public by enhancing the readiness of our Armed Forces and reducing the public cost of service members' lost work time or veterans' disability benefits. Overloaded VA providers and even civilian therapists, who often limit sessions to 60 minutes due to insurance reimbursement requirements, may also be more likely to utilize the shorter treatment format, increasing access to evidence-base care for veterans and civilians. In addition, insights from the study's examination of biomarkers and underlying mechanisms of PE could be used to enhance care for service members, veterans, and the general public. Study risks are minimal, as a small proportion of patients may see temporary symptom increases as they deal with traumatic memories, but this is part of the recovery process. Patients receiving the shorter treatment sessions potentially may realize a lower level of treatment benefits, but preliminary evidence suggests there is good reason to believe their treatment will be equally as successful as those receiving traditional PE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60-minute Prolonged Exposure | Experimental | Behavioral: 60-minute Prolonged Exposure TherapyThis treatment condition is a modified version of Prolonged Exposure therapy for PTSD. It consists of weekly weekly 60-minute sessions, with 20 minutes imaginal exposure. |
| 90-minute Prolonged Exposure | Active comparator | Behavioral: 90-minute Prolonged Exposure TherapyProlonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female active duty military personnel who have deployed since 9/11, ages 18-65 seeking treatment for Posttraumatic Stress Disorder (PTSD).
- Either diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview, OR, CAPS-5 severity ≥ 25 and a PCL-5 score of ≥ 25.
- Able to speak, read, and write English.
Key exclusion criteria (4 listed)
- Current manic or psychotic symptoms required immediate stabilization or hospitalization (as determined by the Manic and Psychosis sections of the Mini International Neuropsychiatric Interview; MINI)
- Current severe alcohol use symptoms (as determined by a score of ≥ 4 on items #4-6 and a total score of ≥ 20 on the Alcohol Use Disorders Identification Test; AUDIT).
- Evidence of a severe traumatic brain injury as determined by marked impairment in communication or comprehension.
- Current suicidal ideation severe enough to warrant immediate crisis intervention (as determined by the Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider).
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 |
|---|---|---|
| 60-minute Prolonged Exposure TherapyThis treatment condition is a modified version of Prolonged Exposure therapy for PTSD. It consists of weekly weekly 60-minute sessions, with 20 minutes imaginal exposure. | Behavioural | 60-minute Prolonged Exposure |
| 90-minute Prolonged Exposure TherapyProlonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure. | Behavioural | 90-minute Prolonged Exposure |
Primary outcome
Interviewer-assessed Posttraumatic Stress Disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for Diagnostic Statistical Manual (DSM)-5
Time frame: Change from baseline to 1-month follow-up (post-treatment)
1 secondary outcome
Self-reported Posttraumatic Stress Disorder (PTSD) symptoms Posttraumatic Stress Checklist for Diagnostic Statistical Manual (DSM)-5
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 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Edna Foa, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60-minute Prolonged Exposure Therapy and 90-minute Prolonged Exposure Therapy in people with Posttraumatic Stress Disorder and Combat Disorder, run by University of Pennsylvania 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 4 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 Apr 2021. 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?
Interviewer-assessed Posttraumatic Stress Disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for Diagnostic Statistical Manual (DSM)-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 Apr 2021.