Leslie A. Morland

Article AbstractObjective: To demonstrate the noninferiority of a telemedicine modality, videoteleconferencing, compared to traditional in-person service delivery of a group psychotherapy intervention for rural combat veterans with posttraumatic stress disorder (PTSD).Method: A randomized controlled noninferiority trial of 125 male veterans with PTSD (according to DSM criteria on the Clinician-Administered PTSD Scale) and anger difficulties was conducted at 3 Veterans Affairs outpatient clinics. Participants were randomly assigned to receive anger management therapy delivered in a group setting with the therapist either in-person (n†‰=†‰64) or via videoteleconferencing (n†‰=†‰61). Participants were assessed at baseline, midtreatment (3 weeks), posttreatment (6 weeks), and 3 and 6 months posttreatment. The primary clinical outcome was reduction of anger difficulties, as measured by the anger expression and trait anger subscales of the State-Trait Anger Expression Inventory-2 (STAXI-2) and by the Novaco Anger Scale total score (NAS-T). Data were collected from August 2005 to October 2008.Results: Participants in both groups showed significant and clinically meaningful reductions in anger symptoms, with posttreatment and 3 and 6 months posttreatment effect sizes ranging from .12 to .63. Using a noninferiority margin of 2 points for STAXI-2 subscales anger expression and trait anger and 4 points for NAS-T outcomes, participants in the videoteleconferencing condition demonstrated a reduction in anger symptoms similar ("non-inferior") to symptom reductions in the in-person groups. Additionally, no significant between-group differences were found on process variables, including attrition, adherence, satisfaction, and treatment expectancy. Participants in the in-person condition reported significantly higher group therapy alliance.Conclusions: Clinical and process outcomes indicate delivering cognitive-behavioral group treatment for PTSD-related anger problems via videoteleconferencing is an effective and feasible way to increase access to evidence-based care for veterans residing in rural or remote locations.Trial Registration: clinicaltrials.gov Identifier: NCT00122109J Clin Psychiatry 2010;71(7):855-863Submitted: August 11, 2009; accepted September 28, 2009.Online ahead of print: January 26, 2010 (doi:10.4088/JCP.09m05604blu).Corresponding author: Leslie A. Morland, PsyD, National Center for PTSD-Pacific Islands Division, Department of Veterans Affairs Pacific Islands Healthcare System, 3375 Koapaka St, Suite I-560, Honolulu, HI 96819 (Leslie.Morland@va.gov).

OBJECTIVE: To compare clinical and process outcomes of cognitive processing therapy-cognitive only version (CPT-C) delivered via videoteleconferencing (VTC) to in-person in a rural, ethnically diverse sample of veterans with posttraumatic stress disorder (PTSD). METHOD: A randomized clinical trial with a noninferiority design was used to determine if providing CPT-C via VTC is effective and "as good as" in-person delivery. The study took place between March 2009 and June 2013. PTSD was diagnosed per DSM-IV. Participants received 12 sessions of CPT-C via VTC (n = 61) or in-person (n = 64). Assessments were administered at baseline, midtreatment, immediately posttreatment, and 3 and 6 months posttreatment. The primary clinical outcome was posttreatment PTSD severity, as measured by the Clinician-Administered PTSD Scale. RESULTS: Clinical and process outcomes found VTC to be noninferior to in-person treatment. Significant reductions in PTSD symptoms were identified at posttreatment (Cohen d = 0.78, P < .05) and maintained at 3- and 6-month follow-up (d = 0.73, P < .05 and d = 0.76, P < .05, respectively). High levels of therapeutic alliance, treatment compliance, and satisfaction and moderate levels of treatment expectancies were reported, with no differences between groups (for all comparisons, F < 1.9, P > .17). CONCLUSIONS: Providing CPT-C to rural residents with PTSD via VTC produced outcomes that were "as good as" in-person treatment. All participants demonstrated significant reductions in PTSD symptoms posttreatment and at follow-up. Results indicate that VTC can offer increased access to specialty mental health care for residents of rural or remote areas. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00879255.

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.

BACKGROUND: 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. METHODS: A randomized controlled trial of Cognitive Processing Therapy, an evidence-based intervention for PTSD, was conducted through a noninferiority design to compare delivery modalities on difference in posttreatment PTSD symptoms. Women with PTSD, including 21 veterans and 105 civilians, were assigned to receive psychotherapy delivered via VTC or NP. Primary treatment outcomes were changes in PTSD symptoms in the completer sample. RESULTS: Improvements in PTSD symptoms in the VTC condition (n = 63) were noninferior to outcomes in the NP condition (n = 63). Clinical outcomes obtained when both conditions were pooled together (N = 126) demonstrated that PTSD symptoms declined substantially posttreatment (mean = -20.5, 95% CI -29.6 to -11.4) and gains were maintained at 3- (mean = -20.8, 95% CI -30.1 to -11.5) and 6-month followup (mean = -22.0, 95% CI -33.1 to -10.9. Veterans demonstrated smaller symptom reductions posttreatment (mean = -9.4, 95% CI -22.5 to 3.7) than civilian women (mean = -22.7, 95% CI -29.9 to -15.5. CONCLUSIONS: Providing psychotherapy to women with PTSD via VTC produced outcomes comparable to NP treatment. VTC can increase access to specialty mental health care for women in rural or remote areas.