Clinical trial NCT02095457: Routine Outcome Monitoring in Mental Health Outpatient
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Affective Disorders
Anxiety Disorders
Psychotic Disorders
Personality Disorders
Keywords: Routine Outcome Monitoring
Psychotherapy
Alliance
Feedback Informed Treatment
Mental Health Outpatients
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 900
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing intake to the clinic and beginning therapy

Exclusion Criteria:

* Mental retardation or dementia
* Hebrew Illiteracy
* Adults who are not under their own legal custody
* Not being able to fulfill the questionnaires with minor help

Primary outcomes:
measure: Overall clinical well-being as measured by the CORE-OM rating scale
timeFrame: up to 3 years follow-up
Secondary outcomes:
measure: Hospitalization rates
timeFrame: up to three years of follow-up
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center Outpatient clinics
Study officials:
References: