The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
Status: | Active, not recruiting |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 12/19/2018 |
Start Date: | September 2013 |
End Date: | October 2020 |
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.
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.
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).
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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