Abstract
BackgroundTrauma-focused psychotherapies for combat-related posttraumatic stress disorder (PTSD) in military veterans are efficacious, but there are many barriers to receiving treatment. The objective of this study was to determine if cognitive processing therapy (CPT) for PTSD among active duty military personnel and veterans would result in increased acceptability, fewer dropouts, and better outcomes when delivered In-Home or by Telehealth as compared to In-Office treatment.MethodsThe trial used an equipoise-stratified randomization design in which participants (N = 120) could decline none or any 1 arm of the study and were then randomized equally to 1 of the remaining arms. Therapists delivered CPT in 12 sessions lasting 60-min each. Self-reported PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5) served as the primary outcome.ResultsOver half of the participants (57%) declined 1 treatment arm. Telehealth was the most acceptable and least often refused delivery format (17%), followed by In-Office (29%), and In-Home (54%); these differences were significant (p = 0.0008). Significant reductions in PTSD symptoms occurred with all treatment formats (p < .0001). Improvement on the PCL-5 was about twice as large in the In-Home (d = 2.1) and Telehealth (d = 2.0) formats than In-Office (d = 1.3); those differences were statistically large and significant (d = 0.8, 0.7 and p = 0.009, 0.014, respectively). There were no significant differences between In-Home and Telehealth outcomes (p = 0.77, d = −.08). Dropout from treatment was numerically lowest when therapy was delivered In-Home (25%) compared to Telehealth (34%) and In-Office (43%), but these differences were not statistically significant.ConclusionsCPT delivered by telehealth is an efficient and effective treatment modality for PTSD, especially considering in-person restrictions resulting from COVID-19.Trial registrationClinicalTrials.gov ID NCT02290847 (Registered 13/08/2014; First Posted Date 14/11/2014).
Highlights
Trauma-focused psychotherapies for combat-related posttraumatic stress disorder (PTSD) in military veterans are efficacious, but there are many barriers to receiving treatment
Many previous telehealth PTSD studies used a hub-and-spoke approach, requiring veterans to travel to a local Veterans Affairs (VA) community-based outpatient clinic or Department of Defense (DoD) medical treatment facility, eliminating potential benefits of home-based telehealth [16, 17]
The most common related Adverse event (AE) reported by more than 3 participants were nightmares (7.5%), sleep difficulty (5.8%), depression (5.0%), anxiety (4.2%), and irritability (4.2%). None of these AEs differed significantly by group after adjustment for the numbers of participants in each group. This randomized clinical trial was the first to use an equipoise-stratified randomization design to evaluate efficacy, acceptability, and dropout of cognitive processing therapy (CPT) delivered via 3 different treatment modalities
Summary
Design The study used an equipoise-stratified randomization design [22, 23] to assign participants with PTSD to receive CPT in 1 of 3 treatment modalities. Four therapist treated participants in all 3 arms of the study and attended weekly consultation calls led by CPT experts. Intent-to-treat (ITT) analyses were used and included all data without regard to engagement in treatment or study participation. The full-sample analyses included separate intercepts for the 3 treatment arms because the samples were not fully randomized. The full-sample analyses have the most precision and broadest generalizability They may not be a valid basis for comparisons of treatments because when the opt-out strata are ignored, the analysis is based on partially non-randomized samples. The fully randomized equipoise-stratified comparison between In-Home and In-Office treatment, for
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