TY - JOUR
T1 - Psychotherapy for depression in older veterans via telemedicine
T2 - A randomised, open-label, non-inferiority trial
AU - Egede, Leonard E.
AU - Acierno, Ron
AU - Knapp, Rebecca G.
AU - Lejuez, Carl
AU - Hernandez-Tejada, Melba
AU - Payne, Elizabeth H.
AU - Frueh, B. Christopher
N1 - Funding Information:
To our knowledge, this is the first randomised controlled trial of manualised evidence-based psychotherapy for depression in older adults via telemedicine ( ). We have shown that this method is feasible and produces outcomes that are no worse than in-person delivery 12 months after treatment. Participants in both groups tolerated and clinically benefitted from behavioural activation for depression. The magnitude of treatment effect noted in this study is similar to what has been noted in treatment studies for depression in veterans. panel 48 Although the treatment response that we noted during the first 8 weeks was significant for both groups, others using behavioural activation with veterans have not noted significant improvement in depression scores. 49 Study retention was excellent, well within the range consistently noted in psychotherapy trials for depression (65–85%), 50 and session attendance was high. Assessment of longitudinal trajectories of BDI and GDS shows a slight worsening at 3 months in both groups, which coincides with the end of treatment sessions. The reason for improvement in the telemedicine group between 3 months and 12 months is unclear, so these findings will need to be assessed in future studies. This study has several important aspects. First, it is one of only a handful of methodologically rigorous, non-inferiority-designed, randomised controlled trials of psychotherapy telemedicine interventions with any population, 30 and the first involving major depression in older adults, a population that often faces barriers of access to care. Second, study implementation was rigorously controlled, including careful a-priori non-inferiority analyses and sample size calculations, careful therapist fidelity monitoring, high study retention and session attendance, follow-up assessments up to 12 months, and examination of clinical outcomes in a difficult-to-treat and understudied clinical sample. Third, the study had broad inclusion criteria that allowed for high psychiatric comorbidity, and thus participants are reasonably representative of the patient population of interest. Finally, this study includes a large sample size and high proportions of rural residents (about 70%) and African Americans (about 40%). Along with its strengths, this study has limitations. First, we conservatively excluded participants with acute safety concerns (homicidal or suicidal), present substance dependence, and active psychosis or dementia. Second, clinical benefit was less than was anticipated when the study was designed. The effect on realised power is negligible in that sample size calculation with proportions is symmetrical, with differences in proportions of 0·7 needing similar power to differences in proportions of 0·3 (with differences in proportions of 0·2 yielding slightly higher power than 0·3). Recruitment exceeded that projected, resulting in slightly higher power for detection of between-group differences than was planned (with corresponding reduction in the false-negative possibility for the comparison). We are uncertain why treatment response was lower than was expected. Our population was probably more sick and had more severe depression and psychiatric comorbidity than those in the studies that we based our estimates on. Third, the information technology used in the study is now somewhat obsolete; however, new technologies should only improve communication between therapists and patients. Fourth, we included very few women in the study sample, and generalisation of results from this subgroup is not guaranteed. Finally, although the focus of this study was on behavioural treatment of depression, some of the patients were also taking antidepressant medications during the study, and we did not specifically track their effects. Potential participants who had recently begun an antidepressant or other prescription medication needed to wait 4 weeks after assessment to ensure medication stabilisation before starting study treatment. However, some antidepressants take longer than 4 weeks to reach maximum effect, particularly in older people, which might have affected study findings. Nevertheless, we expect incremental treatment effects of medications would be the same between groups. We have shown that telemedicine is a viable and effective means of delivery of evidence-based psychotherapy for depression to older adults. Future research should rigorously assess effectiveness of telemedicine in other clinical settings and with other information technologies. For example, evidence exists that landline telephones, 51 mobile phones, 52 and web-based 53 interventions can be effectively used to treat mild-to-moderate depression and might be useful alternatives or adjuncts to videoteleconferencing, depending on patient preferences and access. Finally, implementation research is needed into how to most effectively disseminate telemedicine for populations with depression and integrate it with existing models of care of other disorders that elderly adults face. Contributors LEE, BCF, and RGK drafted the report. RA edited the initial draft. LEE, BCF, RGK, CL, and RA reviewed the report. LEE, BCF, RGK, CL, and RA edited the final version. MH-T drafted the literature review. EHP did data analyses and created the tables and figures. Declaration of interests CL is one of the developers of the manualised Behavioural Activation for Depression protocol used in this study. All other authors declare no competing interests. Acknowledgments This work was supported by grants IIR-04-421-3 from the Veterans Affairs Health Services Research and Development Program. We are deeply appreciative of the veterans and Veterans Affairs primary care and mental health providers who contributed to this research effort. All views and opinions expressed herein are those of the authors and do not necessarily reflect those of our respective institutions or the Department of Veterans Affairs.
Publisher Copyright:
© 2015 Elsevier Ltd.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - 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. Findings: 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. Interpretation: 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. Funding: US Department of Veterans Affairs.
AB - 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. Findings: 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. Interpretation: 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. Funding: US Department of Veterans Affairs.
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U2 - 10.1016/S2215-0366(15)00122-4
DO - 10.1016/S2215-0366(15)00122-4
M3 - Article
C2 - 26249300
AN - SCOPUS:84938293740
SN - 2215-0366
VL - 2
SP - 693
EP - 701
JO - The Lancet Psychiatry
JF - The Lancet Psychiatry
IS - 8
ER -