First enrolment was in December 2008, and is ongoing. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm.
Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary) and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary). A subset of these baseline assessments are repeated after eight weeks of treatment. Baseline assessments include symptoms distress daily function cognitive performance electroencephalogram and event-related potentials heart rate and genetic measures. Study-eligible patients are antidepressant medication (ADM) naïve or willing to undergo a one-week wash-out of any non- protocol ADM, and cannot have had an inadequate response to protocol ADM. It is enrolling 2016 MDD outpatients (ages 18-65) from primary or specialty care practices (672 per treatment arm 672 age-, sex- and education-matched healthy controls). The International Study to Predict Optimized Treatment - in Depression (iSPOT-D) is a multi-centre, international, randomized, prospective, open-label trial.
The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine and develop a model that incorporates multiple predictors and moderators. Williams, Leanne M Rush, A John Koslow, Stephen H Wisniewski, Stephen R Cooper, Nicholas J Nemeroff, Charles B Schatzberg, Alan F Gordon, EvianĬlinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol. Participants randomized to the active and placebo interventions will use the smartphone app for 6 Participants undergoing therapy, presenting serious mental health problems, or legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Two hundred and twenty participants with moderate depressive symptoms (i.e., obtaining scores >9 and ≤16 on the Patient Health Questionnaire, PHQ-9) will be randomized to the three conditions.
#NEYSA EBERHARD OBITUARY FROM NEWTON KANSAN TRIAL#
A randomized, three-arm clinical trial is being conducted (i.e., active intervention, placebo intervention and delayed intervention). Romanian-speaking adults (18Â years and older) with access to a computer and the Internet and owning a smartphone are included in the study. Additionally, we are interested in the app's effect on emotional wellbeing and depressogenic cognitions. The aim of this study is to test a newly developed mobile app firmly grounded in the CBT theory of depression to determine whether this app is clinically useful in decreasing moderate depressive symptoms when compared with an active placebo. This is problematic, as a "digital placebo effect" may explain some of the positive effects documented until now. Moreover, none of them included an active placebo comparison group. However, this small number of studies reports a low statistical power and they have not yet been replicated. As technology has become more integrated into mental health care, computerized cognitive behavioral therapy (CBT) protocols have become available and have been recently transposed to mobile environments (e.g., smartphones) in the form of "apps." Preliminary research on some depression apps has shown promising results in reducing subthreshold or mild to moderate depressive symptoms.
Evidence-based treatments for depression are available, but access to them is still limited in some instances. Giosan, Cezar Cobeanu, Oana MogoaÅŸe, Cristina Szentagotai, Aurora MureÅŸan, Vlad Boian, RareÈ™ĭepression has become one of the leading contributors to the global disease burden. Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial.
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