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

NCT03962504 | Completed Results DMC

• 2 other identifiers: MHBB-005-18FCX001967-01
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

PTSD

Keywords

PTSD; psychosocial treatment; cognitive behavioral treatment; veterans; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• World Health Organization Quality of Life BREF

  change score baseline to 20 weeks

Study Arms (2)

written exposure therapy

EXPERIMENTAL

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

Prolonged Exposure

ACTIVE COMPARATOR

Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures

Behavioral: trauma-focused treatment

Interventions

trauma-focused treatment BEHAVIORAL

cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.

Prolonged Exposure; written exposure therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Sloan DM, Marx BP, Acierno R, Messina M, Muzzy W, Gallagher MW, Litwack S, Sloan C. Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1093-1100. doi: 10.1001/jamapsychiatry.2023.2810.

  PMID: 37610727 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study focused on veteran participants and thus findings may not generalize to the general population. The study also primarily took place during COVID-19 global pandemic, including the height of the initial lockdown, which was a period of increased stress and anxiety.

Results Point of Contact

• Title: Dr. Denise Sloan
• Organization: National Center for PTSD at VA Boston Healthcare System

denise.sloan@va.gov

857-364-6333

Study Officials

• Denise M Sloan, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be unaware of participant conditions. Assessors will not have access to any study materials in which unmasking could occur. Participants will be instructed to not reveal their treatment condition to the assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study is a non-inferiority design to examine if a brief intervention for PTSD is non-inferior to a more time-intensive intervention.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: September 9, 2019
• Primary Completion: January 2, 2023
• Study Completion: December 30, 2023
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: one year

Locations

US (3)