Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
Primary Purpose
Posttraumatic Stress Disorder, PTSD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, PTSD, Prolonged Exposure Therapy, Cognitive Behavioral Therapy
Eligibility Criteria
Inclusion Criteria:
- Primary diagnosis of PTSD
- Recommended by therapist to receive Prolonged Exposure therapy
Exclusion Criteria:
- Current substance dependence, psychosis, suicidal ideation with intent and plan, or other psychiatric problems warranting immediate clinical attention or would interfere with Prolonged Exposure therapy
Sites / Locations
- Center for the Treatment and Study of Anxiety
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
90 minute Prolonged Exposure Sessions
60 minute Prolonged Exposure Sessions
Arm Description
Prolonged Exposure Therapy for PTSD consists of 10 to 15 weekly or twice-weekly sessions, each lasting about 90 minutes, with 40 to 60 minutes imaginal exposure.
This treatment condition is a modified version of Prolonged Exposure therapy for PTSD. It consists of 10 to 15 weekly or twice-weekly sessions, each lasting about 60 minutes, with 20 minutes imaginal exposure.
Outcomes
Primary Outcome Measures
Change in PTSD Symptom Scale, Interview Version (PSS-I; Foa, Riggs, Dancu, & Rothbaum, 1993; Powers, Gillihan, Rosenfield, Jerud & Foa, 2012)
The PSS-I will be administered on 4 separate occasions We will measure the change in PSS-I scores from pre-treatment to post-treatment, 3 month follow-up, and 6 month follow-up.
The PSS-I is a 20-minute, 17-item clinical interview that evaluates DSM-IV PTSD symptoms on a frequency/severity scale. The interview yields a full-scale score and subscales for each of the three PTSD symptom clusters. Psychometric studies revealed internal reliability of .91 for the full scale, and .78, .80, and .82 for the reexperiencing, avoidance and arousal clusters (Foa & Tolin, 2000).
Secondary Outcome Measures
Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
The PDS will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms.
The PDS is a 17-item self-report measure that provides total and subscale severity scores and categorical classification of PTSD. The PDS demonstrated high internal consistency (.92 total, .78 re-experiencing, .84 avoidance, and .84 hyperarousal). Test-retest reliability is good, ranging from .74 to .85. High diagnostic agreement (82%) with the SCID-IV was noted: sensitivity was .89, and specificity, .75. The PDS is highly related to other measures of trauma related psychopathology. Participants will complete this measure at the beginning of every other treatment session.
Beck Depression Inventory (BDI; Beck et al., 1961)
The BDI will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms.
The BDI is a 21-item scale assessing depression. The inventory's internal consistency ranges from .58 to .93, test-retest reliability ranges from .69 to .90. Participants will complete this report measure at the beginning every other treatment session.
Post-Traumatic Cognitions Inventory (PTCI; Foa et al., 1999)
The PTCI will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms.
This 36-item instrument assesses post-trauma cognitions across self, world, and self-blame and yields a total score. The scale has high internal consistency (.97, .88, .86, 97, respectively) and correlates well with PTSD severity, anxiety, and depression (.44 to .79). This 36-item instrument assesses dysfunctional post trauma cognitions theoretically thought to underlie the development of PTSD. Participants will complete this measure at the beginning of every treatment session.
Full Information
NCT ID
NCT01911585
First Posted
July 22, 2013
Last Updated
September 16, 2021
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01911585
Brief Title
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
Official Title
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether 60-minute sessions of prolonged exposure (PE) are as effective as the standard 90-minute session for treating posttraumatic stress disorder (PTSD). Participants will include patients ages 18 or older with a current diagnosis of PTSD who are seeking treatment in our clinic. Patients who have current substance dependence, psychosis, and suicidal ideation with intent and plan may not be suitable for receiving PE and may be offered another treatment or referred to a different treatment center. Participants will be randomized to receive either the 90- minute or 60-minute PE session. A blind evaluator will assess for pre-treatment, post-treatment, and follow-up levels of symptom severity using the PTSD Symptoms Scale Interview (PSS-I). Participants will attend weekly treatment sessions with any of our faculty members and will complete self-report measures at every session (see below).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, PTSD
Keywords
Posttraumatic Stress Disorder, PTSD, Prolonged Exposure Therapy, Cognitive Behavioral Therapy
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
90 minute Prolonged Exposure Sessions
Arm Type
Active Comparator
Arm Description
Prolonged Exposure Therapy for PTSD consists of 10 to 15 weekly or twice-weekly sessions, each lasting about 90 minutes, with 40 to 60 minutes imaginal exposure.
Arm Title
60 minute Prolonged Exposure Sessions
Arm Type
Experimental
Arm Description
This treatment condition is a modified version of Prolonged Exposure therapy for PTSD. It consists of 10 to 15 weekly or twice-weekly sessions, each lasting about 60 minutes, with 20 minutes imaginal exposure.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Intervention Description
Prolonged exposure therapy (PE), a specific exposure therapy program for PTSD is a highly effective treatment for PTSD. The key components of PE are imaginal exposure to the traumatic event and processing it (revisiting of the traumatic memory in imagination) followed by processing of the revisiting experience, and in vivo exposure to avoided trauma-related situations and objects.
Primary Outcome Measure Information:
Title
Change in PTSD Symptom Scale, Interview Version (PSS-I; Foa, Riggs, Dancu, & Rothbaum, 1993; Powers, Gillihan, Rosenfield, Jerud & Foa, 2012)
Description
The PSS-I will be administered on 4 separate occasions We will measure the change in PSS-I scores from pre-treatment to post-treatment, 3 month follow-up, and 6 month follow-up.
The PSS-I is a 20-minute, 17-item clinical interview that evaluates DSM-IV PTSD symptoms on a frequency/severity scale. The interview yields a full-scale score and subscales for each of the three PTSD symptom clusters. Psychometric studies revealed internal reliability of .91 for the full scale, and .78, .80, and .82 for the reexperiencing, avoidance and arousal clusters (Foa & Tolin, 2000).
Time Frame
Pre-treatment through 6 month follow-up
Secondary Outcome Measure Information:
Title
Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
Description
The PDS will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms.
The PDS is a 17-item self-report measure that provides total and subscale severity scores and categorical classification of PTSD. The PDS demonstrated high internal consistency (.92 total, .78 re-experiencing, .84 avoidance, and .84 hyperarousal). Test-retest reliability is good, ranging from .74 to .85. High diagnostic agreement (82%) with the SCID-IV was noted: sensitivity was .89, and specificity, .75. The PDS is highly related to other measures of trauma related psychopathology. Participants will complete this measure at the beginning of every other treatment session.
Time Frame
Pre-treatment through 6 months post-treatment
Title
Beck Depression Inventory (BDI; Beck et al., 1961)
Description
The BDI will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms.
The BDI is a 21-item scale assessing depression. The inventory's internal consistency ranges from .58 to .93, test-retest reliability ranges from .69 to .90. Participants will complete this report measure at the beginning every other treatment session.
Time Frame
Pre-treatment through 6 month follow-up
Title
Post-Traumatic Cognitions Inventory (PTCI; Foa et al., 1999)
Description
The PTCI will be administered at every other treatment session and at post-treatment, 3 month follow-up, and 6 month follow-up. The measure will be used to closely monitor treatment progress and help assess severity of symptoms.
This 36-item instrument assesses post-trauma cognitions across self, world, and self-blame and yields a total score. The scale has high internal consistency (.97, .88, .86, 97, respectively) and correlates well with PTSD severity, anxiety, and depression (.44 to .79). This 36-item instrument assesses dysfunctional post trauma cognitions theoretically thought to underlie the development of PTSD. Participants will complete this measure at the beginning of every treatment session.
Time Frame
Pre-treatment through 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary diagnosis of PTSD
Recommended by therapist to receive Prolonged Exposure therapy
Exclusion Criteria:
Current substance dependence, psychosis, suicidal ideation with intent and plan, or other psychiatric problems warranting immediate clinical attention or would interfere with Prolonged Exposure therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edna B. Foa, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for the Treatment and Study of Anxiety
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35771512
Citation
Foa EB, Bredemeier K, Acierno R, Rosenfield D, Muzzy W, Tuerk PW, Zandberg LJ, Hart S, Young-McCaughan S, Peterson AL, McLean CP. The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. J Consult Clin Psychol. 2022 Jun;90(6):503-512. doi: 10.1037/ccp0000739.
Results Reference
derived
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Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
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