Dataset Information

Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial.

ABSTRACT:

Importance

Posttraumatic stress disorder (PTSD) occurs more commonly among military service members than among civilians; however, despite the availability of several evidence-based treatments, there is a need for more efficient evidence-based PTSD treatments to better address the needs of service members. Written exposure therapy is a brief PTSD intervention that consists of 5 sessions with no between-session assignments, has demonstrated efficacy, and is associated with low treatment dropout rates, but prior randomized clinical trials of this intervention have focused on civilian populations.

Objective

To investigate whether the brief intervention, written exposure therapy, is noninferior in the treatment of PTSD vs the more time-intensive cognitive processing therapy among service members diagnosed with PTSD.

Design, setting, and participants

The study used a randomized, noninferiority design with a 1:1 randomization allocation. Recruitment for the study took place from August 2016 through October 2020. Participants were active-duty military service members diagnosed with posttraumatic stress disorder. The study was conducted in an outpatient setting for service members seeking PTSD treatment at military bases in San Antonio or Killeen, Texas.

Interventions

Participants received either written exposure therapy, which consisted of 5 weekly sessions, or cognitive processing therapy, which consisted of 12 twice-weekly sessions.

Main outcomes and measures

Participants were assessed at baseline and at 10, 20, and 30 weeks after the first treatment session. The primary outcome measure was PTSD symptom severity assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Noninferiority was defined as the difference between the 2 groups being less than the upper bound of the 1-sided 95% CI-specified margin of 10 points on the CAPS-5.

Results

Overall, 169 participants were included in the study. Participants were predominantly male (136 [80.5%]), serving in the Army (167 [98.8%]), with a mean (SD) age of 34 (8) years. Eighty-five participants were randomly assigned to written exposure therapy, with 65 (76.5%) completing all treatment sessions, and 84 to cognitive processing therapy, with 47 (54.8%) completing all treatment sessions. Findings indicated that written exposure therapy was noninferior to cognitive processing therapy, with the largest difference in change in outcome between the treatment conditions of 3.96 points on the outcome measure. The 1-sided 95% CI upper limit was less than 10 points across time points in both groups and ranged from 4.59 at week 30 to 6.81 at week 10. Within-condition effect sizes ranged from a Cohen d of 0.48 for the written exposure therapy group in the intention-to-treat analysis at week 10 to 0.95 for the cognitive processing therapy group in the per-protocol analysis at week 10, and between-condition effect size ranged from 0.06 in the intention-to-treat analysis at week 30 to 0.22 in the per-protocol analysis at week 10.

Conclusions and relevance

In this randomized clinical trial, support was found for an effective and more efficient PTSD treatment approach for service members. Future research should determine who does and does not benefit from PTSD treatment to best maximize treatment outcomes.

Trial registration

ClinicalTrials.gov Identifier: NCT03033602.

SUBMITTER: Sloan DM

PROVIDER: S-EPMC8753496 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Importance:Written exposure therapy (WET), a 5-session intervention, has been shown to efficaciously treat posttraumatic stress disorder (PTSD). However, this treatment has not yet been directly compared with a first-line PTSD treatment such as cognitive processing therapy (CPT). Objective:To determine if WET is noninferior to CPT in patients with PTSD. Design, Setting, and Participants:In this randomized clinical trial conducted at a Veterans Affairs medical facility between February 28, 2013, and November 6, 2016, 126 veteran and nonveteran adults were randomized to either WET or CPT. Inclusion criteria were a primary diagnosis of PTSD and stable medication therapy. Exclusion criteria included current psychotherapy for PTSD, high risk of suicide, diagnosis of psychosis, and unstable bipolar illness. Analysis was performed on an intent-to-treat basis. Interventions:Participants assigned to CPT (n = 63) received 12 sessions and participants assigned to WET (n = 63) received 5 sessions. The CPT protocol that includes written accounts was delivered individually in 60-minute weekly sessions. The first WET session requires 60 minutes while the remaining 4 sessions require 40 minutes. Main Outcomes and Measures:The primary outcome was the total score on the Clinician-Administered PTSD Scale for DSM-5; noninferiority was defined by a score of 10 points. Blinded evaluations were conducted at baseline and 6, 12, 24, and 36 weeks after the first treatment session. Treatment dropout was also examined. Results:For the 126 participants (66 men and 60 women; mean [SD] age, 43.9 [14.6] years), improvements in PTSD symptoms in the WET condition were noninferior to improvements in the CPT condition at each of the assessment periods. The largest difference between treatments was observed at the 24-week assessment (mean difference, 4.31 points; 95% CI, -1.37 to 9.99). There were significantly fewer dropouts in the WET vs CPT condition (4 [6.4%] vs 25 [39.7%]; χ21 = 12.84, Cramer V = 0.40). Conclusions and Relevance:Although WET involves fewer sessions, it was noninferior to CPT in reducing symptoms of PTSD. The findings suggest that WET is an efficacious and efficient PTSD treatment that may reduce attrition and transcend previously observed barriers to PTSD treatment for both patients and providers. Trial Registration:clinicaltrials.gov Identifier: NCT01800773.

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