title: Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial.
abstract: BACKGROUND
  Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans.
  
  
  METHODS
  In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged ≥58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701.
  
  
  RESULTS
  Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in the telemedicine group and 104 (86%) in the same-room group. Treatment response according to GDS did not differ significantly between the telemedicine (22 [22·45%, 90% CI 15·52-29·38] patients) and same-room (21 [20·39%, 90% CI 13·86-26·92]) groups, with an absolute difference of 2·06% (90% CI -7·46 to 11·58). Response according to BDI also did not differ significantly (telemedicine 19 [24·05%, 90% CI 16·14-31·96] patients; same room 19 [23·17%, 90% CI 15·51-30·83]), with an absolute difference of 0·88% (90% CI -10·13 to 11·89). Response on the Structured Clinical Interview for DSM-IV, clinician version, also did not differ significantly (39 [43·33%, 90% CI 34·74-51·93] patients in the telemedicine group and 46 [48·42%, 90% CI 39·99-56·85] in the same-room group), with a difference of -5·09% (-17·13 to 6·95; p=0·487). Results from the intention-to-treat population were similar. MEM analyses showed that no significant differences existed between treatment trajectories over time for BDI and GDS. The criteria for non-inferiority were met. We did not note any adverse events.
  
  
  CONCLUSIONS
  Telemedicine-delivered psychotherapy for older adults with major depression is not inferior to same-room treatment. This finding shows that evidence-based psychotherapy can be delivered, without modification, via home-based telemedicine, and that this method can be used to overcome barriers to care associated with distance from and difficulty with attendance at in-person sessions in older adults.
  
  
  BACKGROUND
  US Department of Veterans Affairs.
authors.affiliation: Health Equity and Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, USA; Center for Health Disparities Research, Division of General Internal Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: egedel@musc.edu.
authors.forename: Leonard E
authors.initials: LE
authors.lastname: Egede
authors.affiliation: Health Equity and Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, USA; College of Nursing, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Ron
authors.initials: R
authors.lastname: Acierno
authors.affiliation: Health Equity and Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, USA; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Rebecca G
authors.initials: RG
authors.lastname: Knapp
authors.affiliation: Health Equity and Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, USA; Department of Psychology, University of Maryland, College Park, MD, USA.
authors.forename: Carl
authors.initials: C
authors.lastname: Lejuez
authors.affiliation: Center for Health Disparities Research, Division of General Internal Medicine, Medical University of South Carolina, Charleston, SC, USA; College of Nursing, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Melba
authors.initials: M
authors.lastname: Hernandez-Tejada
authors.affiliation: Health Equity and Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, USA; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Elizabeth H
authors.initials: EH
authors.lastname: Payne
authors.affiliation: Health Equity and Rural Outreach Innovation Center, Ralph H Johnson Veterans Affairs Medical Center, Charleston, SC, USA; Department of Psychology, University of Hawaii, Hilo, HI, USA; The Menninger Clinic, Houston, TX, USA.
authors.forename: B Christopher
authors.initials: BC
authors.lastname: Frueh
mesh_terms: D003863:Depression / Q000628:therapy*; D003865:Major Depressive Disorder / Q000628:therapy*; D005260:Female; D006297:Health Services Accessibility; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000379:methods*; D017216:Telemedicine / Q000379:methods*; D016896:Treatment Outcome; D014728:Veterans / Q000523:psychology*