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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
60-minute Prolonged Exposure Therapy and 90-minute Prolonged Exposure Therapy
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

Other trials in United States

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.

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 groups in NCT02720497
Study groupRoleWhat they receive
60-minute Prolonged ExposureExperimentalThis 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 ExposureActive comparatorProlonged 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.

  1. 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)
  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.

  1. First posted28 Mar 2016 (estimated)
  2. Study startSep 2013
  3. Primary completionMar 2021
  4. Study completionMar 2021

Resources

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)
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

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.

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