A Comparison of Web-Prolonged Exposure (Web-PE) and Present-Centered Therapy (PCT) for PTSD Among Active-Duty Military Personnel

NCT02556645 | Completed

• 2 other identifiers: W81XWH-14-1-000812012005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this randomized controlled trial is to compare the efficacy and potential biological mechanisms of action of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8-weeks to 10 sessions of Present Centered Treatment (PCT) delivered over 8-weeks by a therapist in 120 active duty military personnel with PTSD. Up to 170 individuals will be consented to obtain data from 120 for analysis. Participants will be assessed at pre-treatment, mid-treatment, and 1-, 3- and 6-months after treatment completion.

Conditions

Posttraumatic Stress Disorders; Combat Disorders

Keywords

Combat; Psychological Treatment; Military; Psychotherapy; Trauma; Posttraumatic Stress; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• To evaluate the efficacy of Web-PE relative to PCT in the reduction of PTSD severity (using the CAPS severity score).

  Three years

• To evaluate the efficacy of Web-PE relative to PCT in the reduction in associated psychopathology

  Associated psychopathology: PTSD diagnosis and severity scores on measures of depression, general anxiety, anger, and PTSD-related cognitions

  Three years

• To evaluate the efficacy of Web-PE relative to PCT in the change in associated biomarkers

  i.e., Cortisol response to awakening, cortisol response to script-driven imagery, salivary and serum neurosteroids.

  Three years

Secondary Outcomes (1)

• Composite ratings on the use of the Web-PE program

  Three years

Study Arms (2)

Web-PE

EXPERIMENTAL

Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).

Other: Web-PE Therapy

PCT

ACTIVE COMPARATOR

Ten 60-minute psychotherapy sessions over 8 weeks, focused on identifying and solving day-to-day problems as they are brought up by the participants. PCT is a manualized therapy that has been used as active control condition in several CBT studies.

Other: Therapist-Delivered Present-Centered Therapy

Interventions

Web-PE Therapy OTHER

Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).

Also known as: Internet-based prolonged exposure

Web-PE

Therapist-Delivered Present-Centered Therapy OTHER

Ten 60-minute psychotherapy sessions over 8 weeks, focused on identifying and solving day-to-day problems as they are brought up by the participants. PCT is a manualized therapy that has been used as active control condition in several CBT studies. It provides a credible comparison therapy to control for nonspecific therapeutic factors so that observed effects of Web-PE can be attributed to its specific ingredients beyond the benefits of good therapy.

Also known as: PCT

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 military personnel or veterans who have deployment since 9/11, ages 18-65 seeking treatment for PTSD. Veterans must be eligible for military medical care on Fort Hood.
• Diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview score ≥ 25. Person has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a period of recent military deployment. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
• Able to speak and read English
• Indication that the participant plans to be in the area for the next five months following the first assessment

You may not qualify if:

• Recent manic episode (past 12 months) or a psychotic disorder (as determined by the bipolar and psychosis sections of the MINI)
• Current alcohol dependence (as determined by an a score of ≥ 4 on items #4-6 and a total score of ≥20 on 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 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
• Recent course of PE within the past 12 months
• Currently engaged in evidence-based treatment for PTSD (e.g. Prolonged Exposure Therapy or Cognitive Processing Therapy

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Texas: collaborator
• VA Palo Alto Health Care System: collaborator

Study Sites (4)

Department of Psychiatry and Behavioral Sciences, Emory University

Atlanta, Georgia, 30322, United States

Location

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 Links

• Link to STRONG STAR research consortium

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Carmen McLean, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Sheila Rauch, Ph.D.

  Emory University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: September 22, 2015
• Study Start: May 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

US (4)