Clinical trial NCT01911585: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
PTSD
Keywords: Posttraumatic Stress Disorder
PTSD
Prolonged Exposure Therapy
Cognitive Behavioral Therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in PTSD Symptom Scale, Interview Version (PSS-I; Foa, Riggs, Dancu, & Rothbaum, 1993; Powers, Gillihan, Rosenfield, Jerud & Foa, 2012)
timeFrame: Pre-treatment through 6 month follow-up
Secondary outcomes:
measure: Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)
timeFrame: Pre-treatment through 6 months post-treatment
measure: Beck Depression Inventory (BDI; Beck et al., 1961)
timeFrame: Pre-treatment through 6 month follow-up
measure: Post-Traumatic Cognitions Inventory (PTCI; Foa et al., 1999)
timeFrame: Pre-treatment through 6 month follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for the Treatment and Study of Anxiety
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Edna B. Foa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.