ROM-Shalvata: Routine Outcome Monitoring in Mental Health Outpatient

Sponsor

Shalvata Mental Health Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02095457

Collaborator

(none)

900

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Affective Disorders Anxiety Disorders Psychotic Disorders Personality Disorders	Behavioral: Frequent monitoring and feedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Frequent Monitoring and Feedback In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy	Behavioral: Frequent monitoring and feedback In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy
Sham Comparator: Infrequent monitoring without feedback In the control arm, patients will infrequently fill short monitoring questionnaires, the results of which are not fed back to their therapists and staff. The frequency of monitoring is between about once a year	Behavioral: Frequent monitoring and feedback In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy

Arm

Intervention/Treatment

Active Comparator: Frequent Monitoring and Feedback

In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy

Behavioral: Frequent monitoring and feedback

Sham Comparator: Infrequent monitoring without feedback

In the control arm, patients will infrequently fill short monitoring questionnaires, the results of which are not fed back to their therapists and staff. The frequency of monitoring is between about once a year

Behavioral: Frequent monitoring and feedback

Outcome Measures

Primary Outcome Measures

Overall clinical well-being as measured by the CORE-OM rating scale [up to 3 years follow-up]
The CORE-OM is a short questionnaire that addresses broad psychiatric symptoms including depression, anxiety, well-being, vocational and domestic functioning, social problems, etc.