NCT03529435

Brief Summary

The study compares two intensive outpatient behavioral programs (Massed Prolonged Exposure versus Intensive Outpatient Prolonged Exposure) for the treatment of posttraumatic stress disorder (PTSD) in post-9/11 active duty service members and veterans. The researchers hope to learn if these programs improve treatment outcomes. The researchers predict that Intensive Outpatient Prolonged Exposure (IOP-PE) will be better at treating PTSD than Massed-Prolonged Exposure (Massed PE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

January 27, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

2.8 years

First QC Date

April 13, 2018

Last Update Submit

August 5, 2022

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Posttraumatic Stress DisorderPTSDPost-Traumatic StressTrauma and Stressor Related DisordersTraumaCombatMilitaryVeteransProlonged ExposureExposure TherapyBehavior TherapyPsychological TreatmentPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • PTSD symptoms

    Change in scale measurements by the Clinician Administered PTSD Scale (CAPS-5). The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Total Score (Range 0-80 with higher scores representing more PTSD symptoms)

    Baseline to 4 Weeks (Posttreatment)

Study Arms (2)

Massed Prolonged Exposure

ACTIVE COMPARATOR

Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks. If necessary, the treatment window may be extended for another week.

Behavioral: Massed Prolonged Exposure

Intensive Outpatient Prolonged Exposure

EXPERIMENTAL

The IOP-PE will include the same primary treatment components as the Massed-PE protocol (fifteen weekday 90-minute PE sessions delivered five days a week over a three-week period) plus eight augmentations designed to maximize treatment outcomes. Similar to the Mass-PE, participants will have three consecutive weeks to complete treatment; however, the treatment window may be extended another week if necessary.

Behavioral: Intensive Outpatient Prolonged Exposure

Interventions

Massed Prolonged ExposureBEHAVIORAL

Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks. If necessary, the treatment window may be extended for another week.

Massed Prolonged Exposure
Intensive Outpatient Prolonged ExposureBEHAVIORAL

The IOP-PE will include the same primary treatment components as the Massed-PE protocol (fifteen weekday 90-minute PE sessions delivered five days a week over a three-week period) plus eight augmentations designed to maximize treatment outcomes. Similar to the Mass-PE, participants will have three consecutive weeks to complete treatment; however, the treatment window may be extended another week if necessary.

Intensive Outpatient Prolonged Exposure

Eligibility Criteria

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

You may qualify if:

  • Active duty military service member or veteran (age 18- 65 years) who deployed in support of combat operations post-9/11 seeking behavioral health treatment for PTSD.
  • PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5).
  • Able to speak and read English (due to standardization of outcome measures)

You may not qualify if:

  • Current manic episode or a psychotic symptoms requiring immediate stabilization or hospitalization (as determined by the bipolar and psychosis modules of the MINI).
  • Current and severe alcohol use warranting immediate intervention based on clinical judgment.
  • 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 Depressive Symptoms Index-Suicidality Subscale and corroborated by a clinical risk assessment by a credentialed provider)
  • Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Central Texas Veterans Health Care System

Waco, Texas, 76504, United States

Location

Related Publications (16)

  • 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: 29362795BACKGROUND

  • Cigrang JA, Rauch SA, Mintz J, Brundige AR, Mitchell JA, Najera E, Litz BT, Young-McCaughan S, Roache JD, Hembree EA, Goodie JL, Sonnek SM, Peterson AL; STRONG STAR Consortium. Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. Fam Syst Health. 2017 Dec;35(4):450-462. doi: 10.1037/fsh0000315.

    PMID: 29283612BACKGROUND

  • Cigrang JA, Rauch SA, Mintz J, Brundige A, Avila LL, Bryan CJ, Goodie JL, Peterson AL; STRONG STAR Consortium. Treatment of active duty military with PTSD in primary care: A follow-up report. J Anxiety Disord. 2015 Dec;36:110-4. doi: 10.1016/j.janxdis.2015.10.003. Epub 2015 Oct 22.

    PMID: 26519833BACKGROUND

  • Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.

    PMID: 26241600BACKGROUND

  • Blount TH, Cigrang JA, Foa EB, Ford HL, Peterson, AL. Intensive outpatient prolonged exposure for combat-related PTSD: A case study. Cognitive and Behavioral Practice. 2014; 21, 89-96. doi:10.1016/j.cbpra.2013.05.004

    BACKGROUND

  • Foa EB, Hembree EA, Rothbaum, BO. Prolonged exposure therapy for PTSD: Emotional processing of traumatic experiences therapist guide. New York, NY: Oxford University Press. 2007.

    BACKGROUND

  • Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.

    PMID: 12182270BACKGROUND

  • Resick PA, Wachen JS, Mintz J, Young-McCaughan S, Roache JD, Borah AM, Borah EV, Dondanville KA, Hembree EA, Litz BT, Peterson AL. A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. J Consult Clin Psychol. 2015 Dec;83(6):1058-1068. doi: 10.1037/ccp0000016. Epub 2015 May 4.

    PMID: 25939018BACKGROUND

  • Bisson JI, Ehlers A, Matthews R, Pilling S, Richards D, Turner S. Psychological treatments for chronic post-traumatic stress disorder. Systematic review and meta-analysis. Br J Psychiatry. 2007 Feb;190:97-104. doi: 10.1192/bjp.bp.106.021402.

    PMID: 17267924BACKGROUND

  • Peterson AL, Foa EB, Riggs DS. Prolonged exposure therapy for combat-related PTSD. In B. A. Moore, & W. Penk (Eds.), Treating PTSD in military personnel: A clinical handbook (pp. 42-58). New York, NY: Guilford. 2011.

    BACKGROUND

  • Peterson AL, Luethcke CA, Borah EV, Borah AM, Young-McCaughan S. Assessment and treatment of combat-related PTSD in returning war veterans. J Clin Psychol Med Settings. 2011 Jun;18(2):164-75. doi: 10.1007/s10880-011-9238-3.

    PMID: 21626355BACKGROUND

  • Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2.

    PMID: 20546985BACKGROUND

  • American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author. 2013.

    BACKGROUND

  • Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr, PP. The PTSD Checklist for DSM-5 (PCL-5). Instrument available from the National Center for PTSD at www.ptsd.va.gov. 2013.

    BACKGROUND

  • Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.

    PMID: 28493729BACKGROUND

  • Peterson AL, Blount TH, Foa EB, Brown LA, McLean CP, Mintz J, Schobitz RP, DeBeer BR, Mignogna J, Fina BA, Evans WR, Synett S, Hall-Clark BN, Rentz TO, Schrader C, Yarvis JS, Dondanville KA, Hansen H, Jacoby VM, Lara-Ruiz J, Straud CL, Hale WJ, Shah D, Koch LM, Gerwell KM, Young-McCaughan S, Litz BT, Meyer EC, Blankenship AE, Williamson DE, Roache JD, Javors MA, Sharrieff AM, Niles BL, Keane TM; Consortium to Alleviate PTSD. Massed vs Intensive Outpatient Prolonged Exposure for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2249422. doi: 10.1001/jamanetworkopen.2022.49422.

    PMID: 36602803DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticTrauma and Stressor Related DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticMental Disorders

Study Officials

  • Alan L Peterson, PhD

    University of Texas Health Science Center at San Antonio; South Texas Veterans Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Independent evaluators, who are blind to treatment condition, conduct semi-structured interviews to assess PTSD diagnosis at the posttreatment, three-month, and six-month follow-up assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 18, 2018

Study Start

January 27, 2017

Primary Completion

November 22, 2019

Study Completion

May 1, 2021

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)