- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813264
Optimizing Outcomes of Dynamic Psychotherapy by the MATRIX: A Preliminary Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the proposed study is to examine, on a preliminary basis, the feasibility of a monitoring and intervention system that will enable the identification and even improvement of ineffective (and even harmful) hours of therapy in dynamic psychotherapy.
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.The duration of the study will be two months. Once the patient and the therapist have signed an informed consent form, they will be integrated into a cellular-based routine outcome monitoring (ROM) that is developed specifically for the present study. This system, which is completely separate from the clinical systems of the Center, is operated after each session by the therapist. Its activation sends an SMS to the patient and to the therapist, in which a referral to a designated and secure site in which questionnaires are administered in order to measure the patient's condition and the assessment of the therapist and the patient regarding the quality of the therapeutic session. In addition, during the entire study period, the hours of treatment will be recorded in a dedicated manual recording device. This is done routinely in many research institutes in Israel and around the world, with the aim of approving the analysis of inefficient or harmful treatment hours. Treatment hours based on ROM data that have a negative effect (ie, evaluated negatively by the patient) will be transcribed by the therapist, and will undergo full MATRIX analysis. In each treatment pair, an analysis of up to two hours will be possible throughout the four months of the study. This analysis includes the conversion of the text to MATRIX codes, 3-letter codes that mark the section speaker (patient or therapist), the subject of the section (patient, therapist, or both) and its character (whether it deals with the ability to experience [ , Or the relationship between experiences [interrelation]). The coding will be performed by the principal investigator or by the secondary investigator. After the encoding analysis, a MATRIX-based feedback will be given by the Principal Investigator to the therapist, in which the recommendations of the analysis will be submitted.
The proposed study combines routine conventional follow-up practices (ROM) in psychotherapy with innovative analysis tools (MATRIX), and seeks to be a first and significant step in addressing the urgent need to implement managed care in psychotherapy. This has far-reaching implications for the management of mental health care in community, clinic, day care and hospitalization units.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hod Hasharon,, Israel
- Shalvata Mental Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who (due to cognitive impairment, language gaps, etc.) are unable to complete a questionnaire with little help.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: preliminary arm
pairs of patients and their therapists
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
implementation of patient/therapist mobile phone based routine monitoring tools in public psychiatric services.
Time Frame: 12 months
|
high adherence rate of routine mobile based measures
|
12 months
|
|
efficiency of a platform that combine monitor and intervene clinical practice
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHA-0013-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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