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Completed

NCT Number: NCT03962504

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

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trauma-focused treatment

Behavioral

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

Primary outcomes

  1. Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5)

    Time frame: change score baseline to 20 weeks

    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.

Secondary outcomes

  1. World Health Organization Quality of Life BREF

    Time frame: change score baseline to 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 24, 2019
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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