Anxiety Disorders Clinical Trial
Official title:
A Randomized Trial of Routine Computerized Outcome and Process Clinical Measures Monitoring in Mental Health Outpatient Services: Preparing for the Planned Public Mental Health Reform in Israel
Scientific Background: Inherent gaps exist between the worlds of research and clinical
therapy, especially in mental-health systems. Developed as an important strategy aimed to
bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a
method devised for systematic ongoing quantitative measurements used in diverse clinical
practices, from psychotherapies to psychiatric management. The efficacy of this approach has
been repeatedly demonstrated in various measures, such as satisfaction with treatment by
patients and therapists, lower drop-out rates, symptomatic benefits, and more.
Objectives: The aim of the current study is to test the feasibility and the clinical
benefits of implementation of a Routine Outcome Monitoring System in a public clinical
center, as a pioneering project in Israel, at the "Shalvata" Mental Health Center.
Working Hypotheses: Incorporation of a ROM system in routine clinical practice is
hypothesized to improve patients' and therapists' overall satisfaction, allow for early
detection and intervention in therapeutic raptures, decrease drop-out rates, and improve
various clinical outcome measures.
Methods: The suggested study is a two-stage (implementation and intervention) open trial.
900 new outpatients in 'Shalvata' clinics will be recruited and randomized to intervention
(ROM) and control groups. Assessment questionnaires will be filled periodically using
'CORE-NET', a computerized system enabling repeated measurements and feedback in a
user-friendly and efficient manner.
Data Analysis: The evaluation of the differential influence of monitoring processes on
overall efficiency as compared to control group will be tested using Multiple Analysis of
Variance (MANOVA). The predictive value of possible variables on process and outcome of
therapy will be assessed using stratified regression analyses. The possible causal effects
between specific lagged variables will be assessed using Hierarchical Linear Modeling and
Time Series Analysis.
Contribution: This pioneering study is the first in Israel to offer a routine systematic
evaluation of therapeutic processes, as well as assessing its clinical effects.
Consequently, a large and meaningful data-set will emerge, enabling significant enrichment
of our evidence-based understanding of therapeutic processes.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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