Prolonged Exposure for Post Traumatic Stress Disorder (PTSD) Among Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Personnel

NCT01049516 | Completed DMC

• 2 other identifiers: PT074199P13W81XWH-08-2-0111
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is 1) to evaluate whether massing 10 PE sessions in 2 weeks (massed trials; M-PE) is more efficacious than Minimal Contact control (MCC); 2) whether the massed sessions format retains the efficacy of treatment compared to 10 PE sessions spaced over 8 weeks (spaced trials; S-PE), and 3) to evaluate for the first time the efficacy of the 10 PE sessions delivered in 8 weeks in an active duty population by comparing it to an active comparison condition, Present-Centered Therapy (PCT).

Conditions

Posttraumatic Stress Disorders; Combat Disorders

Keywords

Military; Combat; Psychological Treatment; Psychotherapy; Trauma; Posttraumatic Stress; Posttraumatic Stress Disorder; PTSD; Prolonged Exposure; Exposure therapy; Behavior Therapy; Cognitive Behavior Therapy; Post-Traumatic Stress Disorders; Stress Disorders, Post-traumatic

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment

  Affect of treatment on this measure of PTSD symptomology

  Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE

Secondary Outcomes (8)

• PTSD Checklist-Stressor-specific version (PCL-S)

  Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)

• PTSD Checklist-Stressor-specific version (PCL-S)

  Post-treatment to 2-week follow-up

• PTSD Checklist-Stressor-specific version (PCL-S)

  2-week follow-up to 12-week follow-up

• PTSD Checklist-Stressor-specific version (PCL-S)

  12-week follow-up to 6-month follow-up

• Changes in PTSD diagnosis using PTSD Symptom Scale, Interview Version (PSS-I) over course of treatment

  Baseline to Post-treatment (approximately 10 weeks for Spaced PE and PCT, 2 weeks for Massed PE)

Study Arms (4)

Minimal Contact Control

OTHER

Behavioral: Minimal Contact Control

PE-Massed

EXPERIMENTAL

Behavioral: Prolonged Exposure Therapy - Massed

PE-Spaced

ACTIVE COMPARATOR

Behavioral: Prolonged Exposure Therapy - Spaced

Present-Centered Therapy (PCT)

ACTIVE COMPARATOR

Behavioral: Present-Centered Therapy

Interventions

Prolonged Exposure Therapy - Massed BEHAVIORAL

10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions occur 5 days/week for two weeks.

Also known as: Massed-PE

PE-Massed

Prolonged Exposure Therapy - Spaced BEHAVIORAL

10 75-90 minute psychotherapy sessions, focused on gradually confronting distressing trauma-related memories and reminders. Sessions 1-3 occur in the first two weeks, Sessions 4-5 occur in Weeks 3-4, and Sessions 6-10 occur in Weeks 5-10.

Also known as: Spaced-PE

PE-Spaced

Minimal Contact Control BEHAVIORAL

Participants receive minimal contact for 4 weeks after randomization and thereafter are offered PE-Spaced or PE-Massed, according to their preference. Participants receive 10-15 minute phone calls once per week by the study therapist or independent evaluator in order to monitor their status and to provide support as needed.

Also known as: Wait List

Minimal Contact Control

Present-Centered Therapy BEHAVIORAL

10 75-90 minute psychotherapy sessions, focused on identifying and solving day-to-day problems as they are brought up by the participants

Present-Centered Therapy (PCT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female active-duty OIF/OEF military personnel and recently separated OIF/OEF veterans ages 18-65 seeking treatment for PTSD
• Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSS-I).

You may not qualify if:

• Current bipolar disorder or other psychotic disorder (as determined by the evaluator conducting the patient interview and medical record review)
• Current alcohol dependence (as determined by the AUDIT)
• Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
• Current suicidal ideation severe enough to warrant immediate attention (as determined by the Scale for Suicidal Ideation)
• Other psychiatric disorders severe enough to warrant designation as the primary disorder

Sponsors & Collaborators

• University of Pennsylvania: lead
• The University of Texas Health Science Center at San Antonio: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (3)

Center for the Treatment and Study of Anxiety, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Carl R. Darnall Army Medical Center

Killeen, Texas, 76544, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

• Taylor DJ, Pruiksma KE, Hale W, McLean CP, Zandberg LJ, Brown L, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Dondanville KA, Litz BT, Roache J, Foa EB. Sleep problems in active duty military personnel seeking treatment for posttraumatic stress disorder: presence, change, and impact on outcomes. Sleep. 2020 Oct 13;43(10):zsaa065. doi: 10.1093/sleep/zsaa065.

  PMID: 32246153 DERIVED

• Brown LA, Zang Y, Benhamou K, Taylor DJ, Bryan CJ, Yarvis JS, Dondanville KA, Litz BT, Mintz J, Roache JD, Pruiksma KE, Fina BA, Young-McCaughan S, Peterson AL, Foa EB; STRONG STAR Consortium. Mediation of suicide ideation in prolonged exposure therapy for posttraumatic stress disorder. Behav Res Ther. 2019 Aug;119:103409. doi: 10.1016/j.brat.2019.103409. Epub 2019 May 23.

  PMID: 31176888 DERIVED

• Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242.

  PMID: 29362795 DERIVED

Related Links

• Link to Strong Star research consortium

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders; Wounds and Injuries

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Edna B. Foa, Ph.D.

  Center for the Treatment and Study of Anxiety, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Elna Yadin, Ph.D.

  Center for the Treatment and Study of Anxiety, University of Pennsylvania

  STUDY DIRECTOR

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: January 12, 2010
• First Posted: January 14, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

US (3)