NCT01911585

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

7.4 years

First QC Date

July 22, 2013

Last Update Submit

September 16, 2021

Conditions

Keywords

Posttraumatic Stress DisorderPTSDProlonged Exposure TherapyCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    Pre-treatment through 6 month follow-up

Secondary Outcomes (3)

  • Posttraumatic Diagnostic Scale (PDS; Foa et al., 1997)

    Pre-treatment through 6 months post-treatment

  • Beck Depression Inventory (BDI; Beck et al., 1961)

    Pre-treatment through 6 month follow-up

  • Post-Traumatic Cognitions Inventory (PTCI; Foa et al., 1999)

    Pre-treatment through 6 month follow-up

Study Arms (2)

90 minute Prolonged Exposure Sessions

ACTIVE COMPARATOR

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.

Behavioral: Prolonged Exposure Therapy

60 minute Prolonged Exposure Sessions

EXPERIMENTAL

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.

Behavioral: Prolonged Exposure Therapy

Interventions

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.

60 minute Prolonged Exposure Sessions90 minute Prolonged Exposure Sessions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of PTSD
  • Recommended by therapist to receive Prolonged Exposure therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for the Treatment and Study of Anxiety

Philadelphia, Pennsylvania, 19106, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Edna B. Foa, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 30, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2021

Study Completion

June 30, 2021

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations