NCT03813264

Brief Summary

Mental disorders require therapeutic effort that contains drug components and psychotherapeutic intervention. The latter requires many resources in light of the skill required. Moreover, such intervention is long, and it takes a long time to assess its effectiveness. The proposed study seeks to implement a management system (ie, a system that monitors and intervenes in ineffective and even harmful treatments) for the purpose of optimizing psychotherapies. The system monitors the improvement in patients' condition in treatment using a mobile phone-based system, and when the treatment is ineffective, it recommends correction strategies. The study will help reduce the ineffective or harmful treatment in dynamic psychotherapy, increasing the quality of care the patient receives. And will lead to the optimal utilization of resources in the mental health system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 3, 2019

Last Update Submit

January 22, 2019

Conditions

Keywords

MATRIXROM (Routine Outcome Measures)mobile-assisted PROMSmanaged care

Outcome Measures

Primary Outcomes (2)

  • implementation of patient/therapist mobile phone based routine monitoring tools in public psychiatric services.

    high adherence rate of routine mobile based measures

    12 months

  • efficiency of a platform that combine monitor and intervene clinical practice

    outcome of psychotherapeutic treatments based on the collection of routine outcomes \[ROM\] and analysis of MATRIX as measured by the OQ-45 (the most common outcome questionnaire in psychotherapy).

    12 months

Study Arms (1)

preliminary arm

EXPERIMENTAL

pairs of patients and their therapists

Other: Routine outcome measures (ROM)

Interventions

The proposed study consists of two complementary processes: the first is the routine collection of clinical data using ROM; The second process is MATRIX-based intervention that is expected to improve the course of treatment.

Also known as: MATRIX (a tool for analysis of therapeutic hours)
preliminary arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects (patients / therapists) over the age of 18.
  • had agreed to participate in the study.
  • eligible for psychotherapeutic treatment.
  • treated with the attending clinician for at least two months.
  • treated/treating with dynamic psychotherapeutic treatment only.

You may not qualify if:

  • Patients who (due to cognitive impairment, language gaps, etc.) are unable to complete a questionnaire with little help.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata Mental Health center

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Shlomo Mendlovich, MD

CONTACT

Hanna Lanchinsky, Mrs

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The proposed study consists of two complementary processes: the first is the routine collection of clinical data using ROM; The second process is MATRIX-based intervention that is expected to improve the course of treatment. The study will take place in the clinic complex located at the Shalvata Mental Health Center campus (Shalva clinic, departmental follow-up clinics, day department), and will include 10 therapists (psychiatrists, psychologists, social workers) and 10 patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of the Shalvata Mental Health Center

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 23, 2019

Study Start

January 1, 2019

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations