Leslie A. Morland

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.

Group cognitive processing therapy delivered to veterans via telehealth: A pilot cohort†

The authors report clinical findings from the pilot cohort of the first prospective, noninferiority-designed randomized clinical trial evaluating the clinical outcomes of delivering a cognitive-behavioral group intervention for posttraumatic stress disorder (PTSD), cognitive processing therapy (CPT), via video teleconferencing (VT) compared to the in-person modality. The treatment was delivered to 13 veterans with PTSD residing on the Hawaiian Islands. Results support the general feasibility and safety of using VT. Both groups showed clinically meaningful reductions in PTSD symptoms and no significant between-group differences on clinical or process outcome variables. In keeping with treatment manual recommendations, a few changes were made to the CPT protocol to accommodate this population. Novel aspects of this trial and lessons learned are discussed.

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.

Intimate Partner Violence and Miscarriage Examination of the Role of Physical and Psychological Abuse and Posttraumatic Stress Disorder

Despite research documenting high rates of violence during pregnancy, few studies have examined the impact of physical abuse, psychological abuse, and posttraumatic stress disorder (PTSD) on miscarriage. Secondary analysis of data collected by the Chicago Womens Health Risk Study permitted an exploration of the relationships among physical abuse, psychological abuse, PTSD, and miscarriage among 118 primarily ethnic minority women. The interaction between maximum severity of abuse and age provided the best multivariate predictor of miscarriage rate, accounting for 26.9% of the variance between live birth and miscarriage outcome. Mean scores of psychological abuse, physical violence, forced sex, and PTSD were significantly higher in the miscarriage group than in the live birth group. Women who experience physical violence and psychological abuse during pregnancy may be at greater risk for miscarriage. Prospective studies can confirm findings and determine underlying mechanisms. Routine screening for traumatic stress and PTSD may reduce rates of miscarriage.

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 VERSUS IN-PERSON DELIVERY OF COGNITIVE PROCESSING THERAPY FOR WOMEN WITH POSTTRAUMATIC STRESS DISORDER: A RANDOMIZED NONINFERIORITY TRIAL

This study examined the effectiveness of telemedicine to provide psychotherapy to women with posttraumatic stress disorder (PTSD) who might be unable to access treatment. Objectives were to compare clinical and process outcomes of PTSD treatment delivered via videoteleconferencing (VTC) and in‐person (NP) in an ethnically diverse sample of veteran and civilian women with PTSD.

Changes in PTSD symptomatology and mental health during pregnancy and postpartum.

Changes in mental health symptoms throughout pregnancy and postpartum may impact a woman’s experience and adjustment during an important time. However, few studies have investigated these changes throughout the perinatal period, particularly changes in posttraumatic stress disorder (PTSD) symptoms. The purpose of this study was to examine longitudinal changes in PTSD, depression, and anxiety symptomatology during pregnancy and postpartum. Pregnant women of ethnically diverse backgrounds receiving services for prenatal care at an outpatient obstetric-gynecology clinic or private physicians’ office were assessed by interview on symptoms of PTSD, depression, anxiety, and general stress up to four times, including their first, second, and third trimester, and postpartum visits. Overall, during pregnancy there was a declining trend of PTSD symptoms. For anxiety, there was no overall significant change over time; however, anxiety symptoms were individually variable in the rate of change. For both depression and general stress symptoms, there was a declining trend, which was also variable in the individual rate of change among women during their pregnancy. Visual and post hoc analyses also suggest a possible peak in PTSD symptoms in the weeks prior to delivery. While most mental health symptoms may generally decrease during pregnancy, given the individual variability among women in the rate of change in symptoms, screening and monitoring of symptom fluctuations throughout the course of pregnancy may be needed. Further studies are needed to examine potential spiking of symptoms in the perinatal period.

Mental Health During Pregnancy: A Study Comparing Asian, Caucasian and Native Hawaiian Women

Objective: This study examines perinatal mental health issues, ethnic differences, and comorbidity among pregnant women in Hawaii. Methods: Eighty-four participants were recruited from women, ages 18–35, seeking prenatal care on Oahu. They were interviewed at their initial prenatal visit about substance use, depression, and anxiety. Results: Sixty-one percent of women screened positive for at least one mental health issue. Thirteen percent of all pregnant women reported drinking during pregnancy with 5% reporting problem drinking, 15% reported smoking cigarettes on a regular basis, 5% of pregnant women had probable depression, and 13% of pregnant women had probable anxiety. Significant ethnic differences were found in cigarette smoking, with the highest rate among Native Hawaiian women (35%). Native Hawaiian women were also more likely to binge drink. Conclusion: Given the high rates of potential mental health issues in our sample, our findings highlight the importance of screening and treatment for mental health issues early in pregnancy in Hawaii.

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.