Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial

An Efficient, Exposure-based Treatment for PTSD Compared to Prolonged Exposure: A Non-inferiority Randomized Trial

The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. One hundred and fifty Veterans diagnosed with PTSD will be randomly assigned to either Written Exposure therapy or Prolonged Exposure. Veteran participants will be assessed at pre-treatment, and 10-, 20-, and 30- weeks post first treatment session. Primary outcome measure will be PTSD symptom severity. The secondary outcome measure will be quality of life. In addition, treatment dropout during the first five sessions will be examined. WET is expected to have a lower treatment dropout rate relative to PE.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: trauma-focused treatment

Detailed Description

Although Written Exposure Therapy (WET) is listed in the upcoming VA/DoD PTSD Practice Guidelines as an evidence-based, recommended PTSD treatment, there are limited data supporting the use of WET with Veterans suffering from PTSD. Additional research is needed to support the use of WET for the treatment of Veterans diagnosed with PTSD. The goal of this study is to investigate whether WET is non-inferior in the treatment of PTSD in a sample of Veterans diagnosed with PTSD. Men and women Veterans diagnosed with PTSD will be randomly assigned to either WET (n = 88) or Prolonged Exposure (PE; n = 90). PTSD symptom severity will serve as the primary outcome. Quality of life will serve as a secondary outcome measure. Assessments will be conducted by independent evaluators at baseline, 10-, 20-, and 20-week post first treatment session. WET is expected to be non-inferior to PE in reducing PTSD symptom severity and functioning. In addition, WET is expected to have significantly lower treatment dropout rate relative to the first five sessions of PE (i.e., better treatment engagement). If WET is found to be non-inferior to the more time intensive PE treatment then the VA will have evidence to support the use of a brief PTSD treatment, which will assist in addressing the high demand for PTSD clinical services.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5799
      • Ralph H. Johnson VA Medical Center, Charleston, SC
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • William S. Middleton Memorial Veterans Hospital, Madison, WI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veteran status
• Current DSM-5 diagnosis of PTSD (assessed with the Clinician Administered PTSD Scale for DSM-5; CAPS-5)
• If taking psychotropic medication, on a stable dose for at least 30 days prior to study entry

Exclusion Criteria:

• Current engagement psychosocial treatment for PTSD

• Current diagnosis of substance dependence

  • abuse will not be excluded; determined with severe combined immunodeficiency (SCID)

• Current psychosis or unstable bipolar disorder diagnosis

  • determined with the Mini International Neuropsychiatric Interview (MINI)clinician-administered interview

• High suicidal risk

  • i.e., intent with a plan; assessed with the MINI suicide module
• Significant cognitive impairment (assessed with the Montreal Cognitive Assessment [MoCA] and clinical judgment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prolonged Exposure; Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures	Behavioral: trauma-focused treatment; cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
Experimental: written exposure therapy; The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.	Behavioral: trauma-focused treatment; cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)	The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity.	change score baseline to 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life BREF	The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete. Total score 0-100, with higher scores indicate greater quality of life.	change score baseline to 20 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Denise M Sloan, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): January 2, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; quality of life; veterans; psychosocial treatment; cognitive behavioral treatment
• Other Study ID Numbers: MHBB-005-18F; CX001967-01 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Datasets meeting VA standards for disclosure to the public will be made available within 1 year after publication. Prior to distribution, a local privacy officer will certify that all datasets contains no protected health information (PHI). Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by Office of Research and Development (ORD). Those requesting data will be asked to sign a Letter of Agreement.
• IPD Sharing Time Frame: one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No