Carolyn J. Greene

Noninferiority and equivalence designs: issues and implications for mental health research.

The terms noninferiority and equivalence are often used interchangeably to refer to trials in which the primary objective is to show that a novel intervention is as effective as the standard intervention. The use of these designs is becoming increasingly relevant to mental health research. Despite the fundamental importance of these designs, they are often poorly understood, improperly applied, and subsequently misinterpreted. In this article, the authors explain noninferiority and equivalence designs and key methodological and statistical considerations. Decision points in using these designs are discussed, such as choice of control condition, determination of the noninferiority margin, and calculation of sample size and power. With increasing utilization of these designs, it is critical that researchers understand the methodological issues, advantages, disadvantages, and related challenges.

How Does Tele-Mental Health Affect Group Therapy Process? Secondary Analysis of a Noninferiority Trial

OBJECTIVE Video teleconferencing (VTC) is used for mental health treatment delivery to geographically remote, underserved populations. However, few studies have examined how VTC affects individual or group psychotherapy processes. This study compares process variables such as therapeutic alliance and attrition among participants receiving anger management group therapy either through traditional face-to-face delivery or by VTC. METHOD The current study represents secondary analyses of a randomized noninferiority trial (Morland et al., in press) in which clinical effectiveness of VTC delivery proved noninferior to in-person delivery. Participants were male veterans (N = 112) with posttraumatic stress disorder (PTSD) and moderate to severe anger problems. The present study examined potential differences in process variables, including therapeutic alliance, satisfaction, treatment credibility, attendance, homework completion, and attrition. RESULTS No significant differences were found between the two modalities on most process variables. However, individuals in the VTC condition exhibited lower alliance with the group leader than those in the in-person condition. Mean self-leader alliance scores were 4.2 (SD = 0.8) and 4.5 (SD = 0.4), respectively, where 5 represents strongly agree and 4 represents agree with positive statements about the relationship, suggesting that participants in both conditions felt reasonably strong alliance in absolute terms. Individuals who had stronger alliance tended to have better anger outcomes, yet the effect was not strong enough to result in the VTC condition producing inferior aggregate outcomes. CONCLUSION Our findings suggest that even if group psychotherapy via VTC differs in subtle ways from in-person delivery, VTC is a viable and effective means of delivering psychotherapy.

Women at war: implications for mental health.

Few studies have investigated the impact of deployment stressors on the mental health outcomes of women deployed to Iraq in support of Operation Iraqi Freedom. This pilot study examined exposure to combat experiences and military sexual harassment in a sample of 54 active duty women and assessed the impact of these stressors on post-deployment posttraumatic stress disorder (PTSD) symptoms and depressive symptoms. Within 3 months of returning from deployment to Iraq, participants completed (a) the Combat Experiences Scale and the Sexual Harassment Scale of the Deployment Risk and Resilience Inventory, (b) the Primary Care PTSD Screen, and (c) an abbreviated version of the Center for Epidemiological Studies–Depression scale. Approximately three quarters of the sample endorsed exposure to combat experiences, and more than half of the sample reported experiencing deployment-related sexual harassment, with nearly half of the sample endorsing both stressors. Approximately one third of the sample endorsed clinical or subclinical levels of PTSD symptoms, with 11% screening positive for PTSD and 9% to 14% of the sample endorsing depressive symptoms. Regression analyses revealed that combat experiences and sexual harassment jointly accounted for significant variance in post-deployment PTSD symptoms, whereas military sexual harassment was identified as the only unique significant predictor of these symptoms. Findings from the present study lend support to research demonstrating that military sexual trauma may be more highly associated with post-deployment PTSD symptoms than combat exposure among female service members and veterans.

Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD

This methodological article provides a description of the design, methods, and rationale of the first prospective, noninferiority designed randomized clinical trial evaluating the clinical and cost implications of delivering an evidence-based cognitive-behavioral group intervention specifically treating posttraumatic stress disorder (PTSD) with a trauma-focused intervention via video teleconferencing (VTC). PTSD is a prevalent mental health problem found among returning Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) military populations. These returning military personnel often live in rural areas and therefore have limited access to care and specialized psychological treatments. In the field of mental health, telemental health (TMH) technology has introduced a potential solution to the persistent problem of access to care in remote areas. This study is enrolling approximately 126 returning veterans with current combat-related PTSD who are receiving services through the Veteran Administration (VA) mental health care clinics on 4 Hawaiian Islands. Cognitive Processing Therapy (CPT), an empirically supported manualized treatment for PTSD, is being delivered across 9 cohorts. Participants are assigned to either the experimental VTC condition or the in-person control condition. Assessments measuring clinical, process, and cost outcomes are being conducted at baseline, mid-treatment, post-treatment, and 3 and 6 months post-treatment. The study employs a noninferiority design to determine if the group treatment delivered via VTC is as good as the traditional in-person modality. In addition, a cost analysis will be performed in order to compare the cost of the 2 modalities. Novel aspects of this trial and specific challenges are discussed.

Telemedicine: a cost-reducing means of delivering psychotherapy to rural combat veterans with PTSD.

BACKGROUND Although effective psychotherapies for posttraumatic stress disorder (PTSD) exist, high percentages of Veterans in need of services are unable to access them. One particular challenge to providing cost-effective psychological treatments to Veterans with PTSD involves the difficulty and high cost of delivering in-person, specialized psychotherapy to Veterans residing in geographically remote locations. The delivery of these services via clinical videoteleconferencing (CVT) has been presented as a potential solution to this access to care problem. MATERIALS AND METHODS This study is a retrospective cost analysis of a randomized controlled trial investigating telemedicine service delivery of an anger management therapy for Veterans with PTSD. The parent trial found that the CVT condition provided clinical results that were comparable to the in-person condition. Several cost outcomes were calculated in order to investigate the clinical and cost outcomes associated with the CVT delivery modality relative to in-person delivery. RESULTS The CVT condition was significantly associated with lower total costs compared with the in-person delivery condition. The delivery of mental health services via CVT enables Veterans who would not normally receive these services access to empirically based treatments. Additional studies addressing long-term healthcare system costs, indirect cost factors at the patient and societal levels, and the use of CVT in other geographic regions of the United States are needed. CONCLUSIONS The results of this study provide evidence that CVT is a cost-reducing mode of service delivery to Veterans with PTSD relative to in-person delivery.

Therapist adherence to manualized cognitive-behavioral therapy for anger management delivered to veterans with PTSD via videoconferencing †

Therapist adherence to a manualized cognitive-behavioral anger management group treatment (AMT) was compared between therapy delivered via videoconference (VC) and the traditional in-person modality, using data from a large, randomized controlled trial comparing the effectiveness of AMT for veterans with combat-related posttraumatic stress disorder. Therapist adherence was rated for the presence or absence of process and content treatment elements. Secondary analyses were conducted using a repeated measures ANOVA. Overall adherence to the protocol was excellent (M = 96%, SD = 1%). Findings indicate that therapist adherence to AMT is similar across delivery modalities and VC is a viable service delivery strategy that does not compromise a therapists ability to effectively structure sessions and manage patient care.

Peeking into the black box: mechanisms of action for anger management treatment.

We investigated potential mechanisms of action for anger symptom reductions, specifically, the roles of anger regulation skills and therapeutic alliance on changes in anger symptoms, following group anger management treatment (AMT) among combat veterans with posttraumatic stress disorder (PTSD). Data were drawn from a published randomized controlled trial of AMT conducted with a racially diverse group of 109 veterans with PTSD and anger symptoms residing in Hawaii. Results of latent growth curve models indicated that gains in calming skills predicted significantly larger reductions in anger symptoms at post-treatment, while the development of cognitive coping and behavioral control skills did not predict greater symptom reductions. Therapeutic alliance had indirect effects on all outcomes mostly via arousal calming skills. Results suggest that generalized symptom reduction may be mediated by development of skills in calming physiological arousal. In addition, arousal reduction skills appeared to enhance ones ability to employ other anger regulation skills.

Current Trends in Using Internet and Mobile Technology to Support the Treatment of Substance Use Disorders

ISSUES By allowing for the efficient delivery of instructional content and the secure collection of self-report data regarding substance use and related problems, the Internet has tremendous potential to improve the effectiveness and accessibility of Substance Use Disorder (SUD) treatment and recovery-oriented services. APPROACH This article discusses some of the ways in which Internet and mobile technology can facilitate, complement and support the process of traditional clinician-delivered treatment for individuals with SUDs. KEY FINDINGS Internet applications are being used to support a range of activities including (a) the assessment and feedback process that constitutes a key feature of brief motivational interventions; and (b) the concurrent monitoring of patients who are receiving treatment for SUDs, to support continuing care, and the ongoing recovery of SUD patients who have completed face-to-face treatment. Internet technology is also being used to (c) support efficient delivery of clinical training in evidence-based practices for treating individuals who may have SUDs. IMPLICATIONS This emerging body of literature suggests that SUD treatment providers and program administrators can enhance the quality of clinician-delivered treatment by incorporating internet applications into existing processes of care and recovery oriented services. CONCLUSION Internet applications provide an unparalleled opportunity to engage patients in the treatment process, incorporate real-time data into treatment planning, prevent relapse, and promote evidence-based treatment approaches.

A pilot program in telepsychiatry for residents: initial outcomes and program development.

Telepsychiatry, the use of video teleconferencing to deliver psychiatric services, has expanded dramatically in recent years [1]. Telepsychiatry is equally effective compared to face-to-face care for the provision of medication management and a variety of psychotherapies [2–6]. Telepsychiatry can be deployed on a very large scale with very positive impact. For example, a study of 98,609 patients at the US Department of Veterans Affairs (VA) demonstrated a significant reduction in inpatient hospitalizations after initiation of telepsychiatry [7]. Telepsychiatry has the potential to deliver care directly into the patient’s environment in a way that reduces sigma, increases access, and, along with other technologies, creates a paradigm shift in how we provide care [8]. Given this potential, it is vital that training in telepsychiatry become a standard component of psychiatry residency programs. A recent survey of psychiatry residents across the USA revealed that although themajority of the 283 respondents expressed interest in telepsychiatry, only 17.6 % had any clinical exposure and 48%of thosewith exposure had received less than 6 h of training [9]. These findings clearly indicate telepsychiatry training has yet to become a standard part of psychiatry residency. In the literature, information on training program best practices is only beginning to be addressed [10–15]. In this report, we describe our experience developing a 6-month, required training rotation in telepsychiatry for third year psychiatry residents.

Predictors of Anger Treatment Outcomes

OBJECTIVE This study investigated predictors of therapeutic outcomes for veterans who received treatment for dysregulated anger. METHOD Data are from a randomized controlled trial investigating the effectiveness of video teleconferencing compared to in-person delivery of anger management therapy (AMT) among 125 military veterans. Multilevel modeling was used to assess 2 types of predictors (demographic characteristics and mental health factors) of changes in anger symptoms after treatment. RESULTS Results showed that while veterans benefited similarly from treatment across modalities, veterans who received two or more additional mental health services and who had longer commutes to care showed the greatest improvement on a composite measure of self-reported anger symptoms. CONCLUSION Results highlight that veterans with a range of psychosocial and mental health characteristics benefited from AMT, while those receiving the most additional concurrent mental health services had better outcomes.