Affective DisordersROM-ShalvataNCT02095457
Routine Outcome Monitoring in Mental Health Outpatient
A study testing Frequent monitoring and feedback in people with Affective Disorders and Anxiety Disorders, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Affective Disorders, Anxiety Disorders, Psychotic Disorders
- What is being tested?
- Frequent monitoring and feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing intake to the clinic and beginning therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shalvata Mental Health Center Outpatient clinics
Hod HaSharon
Lior Biran, Clinical Psychologist, 972-54-4708886, liorbiran@gmail.com, liorbi@clalit.org.il
Lior Biran
About this study
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.
Read more
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.
- Being tested
- Frequent monitoring and feedback
- Keywords
- Routine Outcome Monitoring, Psychotherapy, Alliance, Feedback Informed Treatment, Mental Health Outpatients
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Psychotic Disorders, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequent monitoring and feedbackBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Frequent Monitoring and Feedback | Active comparator | 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 Receives: Behavioral: Frequent monitoring and feedback |
| Infrequent monitoring without feedback | Sham comparator | 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 Receives: Behavioral: Frequent monitoring and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall clinical well-being as measured by the CORE-OM rating scale
The CORE-OM is a short questionnaire that addresses broad psychiatric symptoms including depression, anxiety, well-being, vocational and domestic functioning, social problems, etc.
Measured: up to 3 years follow-up
Secondary outcomes (1)
Hospitalization rates
Measured: up to three years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affective DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Ganor, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095457
- Sponsor's protocol ID
- NIHP-R-161-2013
- Other IDs
- R-161-2013
- Acronym
- ROM-Shalvata
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02095457
- Acronym / sponsor ID
- ROM-Shalvata / NIHP-R-161-2013
- Keywords
- Routine Outcome Monitoring, Psychotherapy, Alliance, Feedback Informed Treatment, Mental Health Outpatients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (estimated)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frequent Monitoring and Feedback | Active comparator | Behavioral: Frequent monitoring and feedbackIn 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 |
| Infrequent monitoring without feedback | Sham comparator | Behavioral: Frequent monitoring and feedbackIn 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 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing intake to the clinic and beginning therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequent monitoring and feedbackIn 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 | Behavioural | Frequent Monitoring and Feedback, Infrequent monitoring without feedback |
Primary outcome
Overall clinical well-being as measured by the CORE-OM rating scale
Time frame: 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.
1 secondary outcome
Hospitalization rates
Time frame: up to three years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequent monitoring and feedback in people with Affective Disorders and Anxiety Disorders, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ori Ganor, MD (972-54-5454886, origa1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall clinical well-being as measured by the CORE-OM rating scale (time frame: up to 3 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.