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The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD

Primary Purpose

Posttraumatic Stress Disorder, Combat Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
60-minute Prolonged Exposure Therapy
90-minute Prolonged Exposure Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Adult male and female active duty military personnel who have deployed since 9/11, ages 18-65 seeking treatment for Posttraumatic Stress Disorder (PTSD).
  2. 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.
  3. Able to speak, read, and write English.

Exclusion Criteria

  1. 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)
  2. 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).
  3. Evidence of a severe traumatic brain injury as determined by marked impairment in communication or comprehension.
  4. 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).

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

60-minute Prolonged Exposure

90-minute Prolonged Exposure

Arm Description

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.

Prolonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure.

Outcomes

Primary Outcome Measures

Interviewer-assessed Posttraumatic Stress Disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for Diagnostic Statistical Manual (DSM)-5

Secondary Outcome Measures

Self-reported Posttraumatic Stress Disorder (PTSD) symptoms Posttraumatic Stress Checklist for Diagnostic Statistical Manual (DSM)-5

Full Information

First Posted
March 10, 2016
Last Updated
April 14, 2021
Sponsor
University of Pennsylvania
Collaborators
Medical University of South Carolina, U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT02720497
Brief Title
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Medical University of South Carolina, U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Combat Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60-minute Prolonged Exposure
Arm Type
Experimental
Arm Description
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.
Arm Title
90-minute Prolonged Exposure
Arm Type
Active Comparator
Arm Description
Prolonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure.
Intervention Type
Behavioral
Intervention Name(s)
60-minute Prolonged Exposure Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
90-minute Prolonged Exposure Therapy
Intervention Description
Prolonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edna Foa, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD

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