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A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial.

ABSTRACT: 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.

SUBMITTER: Sloan DM

PROVIDER: S-EPMC5843538 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportancePosttraumatic 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.ObjectiveTo 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 participantsThe 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.InterventionsParticipants 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 measuresParticipants 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.ResultsOverall, 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 relevanceIn 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 registrationClinicalTrials.gov Identifier: NCT03033602.

Project description:ImportancePosttraumatic stress disorder (PTSD) is a prevalent and serious mental health problem. Although there are effective psychotherapies for PTSD, there is little information about their comparative effectiveness.ObjectiveTo compare the effectiveness of prolonged exposure (PE) vs cognitive processing therapy (CPT) for treating PTSD in veterans.Design, setting, and participantsThis randomized clinical trial assessed the comparative effectiveness of PE vs CPT among veterans with military-related PTSD recruited from outpatient mental health clinics at 17 Department of Veterans Affairs medical centers across the US from October 31, 2014, to February 1, 2018, with follow-up through February 1, 2019. The primary outcome was assessed using centralized masking. Tested hypotheses were prespecified before trial initiation. Data were analyzed from October 5, 2020, to May 5, 2021.InterventionsParticipants were randomized to 1 of 2 individual cognitive-behavioral therapies, PE or CPT, delivered according to a flexible protocol of 10 to 14 sessions.Main outcomes and measuresThe primary outcome was change in PTSD symptom severity on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from before treatment to the mean after treatment across posttreatment and 3- and 6-month follow-ups. Secondary outcomes included other symptoms, functioning, and quality of life.ResultsAnalyses were based on all 916 randomized participants (730 [79.7%] men and 186 [20.3%] women; mean [range] age 45.2 [21-80] years), with 455 participants randomized to PE (mean CAPS-5 score at baseline, 39.9 [95% CI, 39.1-40.7] points) and 461 participants randomized to CPT (mean CAPS-5 score at baseline, 40.3 [95% CI, 39.5-41.1] points). PTSD severity on the CAPS-5 improved substantially in both PE (standardized mean difference [SMD], 0.99 [95% CI, 0.89-1.08]) and CPT (SMD, 0.71 [95% CI, 0.61-0.80]) groups from before to after treatment. Mean improvement was greater in PE than CPT (least square mean, 2.42 [95% CI, 0.53-4.31]; P = .01), but the difference was not clinically significant (SMD, 0.17). Results for self-reported PTSD symptoms were comparable with CAPS-5 findings. The PE group had higher odds of response (odds ratio [OR], 1.32 [95% CI, 1.00-1.65]; P < .001), loss of diagnosis (OR, 1.43 [95% CI, 1.12-1.74]; P < .001), and remission (OR, 1.62 [95% CI, 1.24-2.00]; P < .001) compared with the CPT group. Groups did not differ on other outcomes. Treatment dropout was higher in PE (254 participants [55.8%]) than in CPT (215 participants [46.6%]; P < .01). Three participants in the PE group and 1 participant in the CPT group were withdrawn from treatment, and 3 participants in each treatment dropped out owing to serious adverse events.Conclusions and relevanceThis randomized clinical trial found that although PE was statistically more effective than CPT, the difference was not clinically significant, and improvements in PTSD were meaningful in both treatment groups. These findings highlight the importance of shared decision-making to help patients understand the evidence and select their preferred treatment.Trial registrationClinicalTrials.gov Identifier: NCT01928732.

Project description:ImportanceAdditional options are needed for treatment of posttraumatic stress disorder (PTSD) among veterans.ObjectiveTo determine whether group loving-kindness meditation is noninferior to group cognitive processing therapy for treatment of PTSD.Design, setting, and participantsThis randomized clinical noninferiority trial assessed PTSD and depression at baseline, posttreatment, and 3- and 6-month follow-up. Veterans were recruited from September 24, 2014, to February 5, 2018, from a large Veternas Affairs medical center in Seattle, Washington. A total of 184 veteran volunteers who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for PTSD were randomized. Data collection was completed November 28, 2018, and data analyses were conducted from December 10, 2018, to November 5, 2019.InterventionsEach intervention comprised 12 weekly 90-minute group sessions. Loving-kindness meditation (n = 91) involves silent repetition of phrases intended to elicit feelings of kindness for oneself and others. Cognitive processing therapy (n = 93) combines cognitive restructuring with emotional processing of trauma-related content.Main outcomes and measuresCo-primary outcomes were change in PTSD and depression scores over 6-month follow-up, assessed by the Clinician-Administered PTSD Scale (CAPS-5; range, 0-80; higher is worse) and Patient-Reported Outcome Measurement Information System (PROMIS; reported as standardized T-score with mean [SD] of 50 [10] points; higher is worse) depression measures. Noninferiority margins were 5 points on the CAPS-5 and 4 points on the PROMIS depression measure.ResultsAmong the 184 veterans (mean [SD] age, 57.1 [13.1] years; 153 men [83.2%]; 107 White participants [58.2%]) included in the study, 91 (49.5%) were randomized to the loving-kindness group, and 93 (50.5%) were randomized to the cognitive processing group. The mean (SD) baseline CAPS-5 score was 35.5 (11.8) and mean (SD) PROMIS depression score was 60.9 (7.9). A total of 121 veterans (66%) completed 6-month follow-up. At 6 months posttreatment, mean CAPS-5 scores were 28.02 (95% CI, 24.72-31.32) for cognitive processing therapy and 25.92 (95% CI, 22.62-29.23) for loving-kindness meditation (difference, 2.09; 95% CI, -2.59 to 6.78), and mean PROMIS depression scores were 61.22 (95% CI, 59.21-63.23) for cognitive processing therapy and 58.88 (95% CI, 56.86-60.91) for loving-kindness meditation (difference, 2.34; 95% CI, -0.52 to 5.19). In superiority analyses, there were no significant between-group differences in CAPS-5 scores, whereas for PROMIS depression scores, greater reductions were found for loving-kindness meditation vs cognitive processing therapy (for patients attending ≥6 visits, ≥4-point improvement was noted in 24 [39.3%] veterans receiving loving-kindness meditation vs 9 (18.0%) receiving cognitive processing therapy; P = .03).Conclusions and relevanceAmong veterans with PTSD, loving-kindness meditation resulted in reductions in PTSD symptoms that were noninferior to group cognitive processing therapy. For both interventions, the magnitude of improvement in PTSD symptoms was modest. Change over time in depressive symptoms was greater for loving-kindness meditation than for cognitive processing therapy.Trial registrationClinicaltrials.gov Identifier: NCT01962714.

Project description:ImportanceFirst-line treatment for posttraumatic stress disorder (PTSD) in the US Department of Veterans Affairs (VA), ie, trauma-focused therapy, while effective, is limited by low treatment initiation, high dropout, and high treatment refraction.ObjectiveTo evaluate the effectiveness of Trauma Center Trauma-Sensitive Yoga (TCTSY) vs first-line cognitive processing therapy (CPT) in women veterans with PTSD related to military sexual trauma (MST) and the hypothesis that PTSD outcomes would differ between the interventions.Design, setting, and participantsThis multisite randomized clinical trial was conducted from December 1, 2015, to April 30, 2022, within 2 VA health care systems located in the southeast and northwest. Women veterans aged 22 to 71 years with MST-related PTSD were enrolled and randomized to TCTSY or CPT.InterventionsThe TCTSY intervention (Hatha-style yoga focusing on interoception and empowerment) consisted of 10 weekly, 60-minute group sessions, and the CPT intervention (cognitive-based therapy targeting modification of negative posttraumatic thoughts) consisted of 12 weekly, 90-minute group sessions.Main outcome and measuresSociodemographic data were collected via self-report survey. The primary outcome, PTSD symptom severity, was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD Checklist for DSM-5 (PCL-5). Assessments were conducted at baseline, midintervention, 2 weeks post intervention, and 3 months post intervention.ResultsOf 200 women veterans who consented to participate, the intent-to-treat sample comprised 131 participants (mean [SD] age, 48.2 [11.2] years), with 72 randomized to TCTSY and 59 randomized to CPT. Treatment was completed by 47 participants (65.3%) in the TCTSY group and 27 (45.8%) in the CPT group, a 42.6% higher treatment completion rate in the TCTSY group (P = .03). Both treatment groups improved over time on the CAPS-5 (mean [SD] scores at baseline: 36.73 [8.79] for TCTSY and 35.52 [7.49] for CPT; mean [SD] scores at 3 months: 24.03 [11.55] for TCTSY and 22.15 [13.56]) and the PCL-5 (mean [SD] scores at baseline: 49.62 [12.19] for TCTSY and 48.69 [13.62] for CPT; mean [SD] scores at 3 months: 36.97 [17.74] for TCTSY and 31.76 [12.47]) (P < .001 for time effects). None of the group effects or group-by-time effects were significant. Equivalence analyses of change scores were not significantly different between the TCTSY and CPT groups, and the two one-sided test intervals fell within the equivalence bounds of plus or minus 10 for CAPS-5 for all follow-up time points.Conclusions and relevanceIn this comparative effectiveness randomized clinical trial, TCTSY was equivalent to CPT in reducing PTSD symptom severity, with both groups improving significantly. The higher treatment completion rate for TCTSY indicates its higher acceptability as an effective and acceptable PTSD treatment for women veterans with PTSD related to MST that could address current VA PTSD treatment limitations.Trial registrationClinicalTrials.gov Identifier: NCT02640690.

Project description:ImportanceCo-occurrence of posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) is common and associated with psychiatric and functional problems. Understanding whether exposure therapy is tolerable and efficacious for treating PTSD and AUD is critical to ensure that best practice treatments are available.ObjectiveTo compare the efficacy of integrated (ie, targeting both PTSD and alcohol use) prolonged exposure (I-PE) therapy with present-centered integrated coping skills (I-CS) therapy, a more commonly available treatment, in reducing PTSD symptoms and alcohol use.Design, setting, and participantsThis prospective randomized clinical trial with masked assessments considered 186 veterans seeking Veterans Affairs mental health services. A total of 119 veterans with PTSD and AUD were randomized. Data were collected from February 1, 2013, to May 31, 2017, before treatment, after treatment, and at 3- and 6-month follow-ups. Intention-to-treat analyses were performed.InterventionsVeterans underwent I-PE (Concurrent Treatment of PTSD and Substance Use Disorder Using Prolonged Exposure) or I-CS (Seeking Safety) therapy.Main outcomes and measuresA priori planned outcomes were PTSD symptoms (Clinician Administered PTSD Scale for DSM-5) and percentage of heavy drinking days (Timeline Follow-Back) before treatment, after treatment, and at 3- and 6-month follow-ups.ResultsA total of 119 veterans (mean [SD] age, 41.6 [12.6] years; 107 [89.9%] male) were randomized. Linear mixture models found that PTSD symptoms decreased in both conditions, with a significantly greater decrease for I-PE treatment compared with I-CS treatment (treatment × time interaction, -2.83; F3,233.1 = 4.92; Cohen d = 0.41; P = .002). The percentage of heavy drinking days improved in both conditions but was not statistically different between I-PE and I-CS treatment (treatment × time interaction, 1.8%; F3,209.9 = 0.18; Cohen d = 0.04; P = .91).Conclusions and relevanceThe I-PE arm had a greater reduction in PTSD symptoms than the I-CS arm and comparable drinking decreases. The study provides evidence that exposure therapy is more efficacious in treating PTSD than a more commonly available integrated treatment without exposure for comorbid PTSD and AUD.Trial registrationClinicalTrials.gov identifier: NCT01601067.

Project description: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).

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A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial.

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