Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03608449
Recruitment Status : Not yet recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief Summary:

Psychotherapy is one of the cornerstones of mental health services. It is provided by psychiatrist, psychologists and psychiatric social worker in both hospital and out-patient services, and is assumed to require massive manpower and training inputs.

Internationally, the clinical outcomes of routine mental health services are rarely recorded or reported. However, a rough estimation is that half (40-60%) of all psychotherapies have a favorable clinical outcome. Recently (Clark et al, 2017), the English Improving Access to Psychological Therapies (IAPT) Program, which delivers psychotherapies to more than 537 000 patients in the UK each year, indicated that 44% of the patients recovered, and 62%- improved. Consistent with a causal model, most organizational factors also predicted between-year changes in outcome, together accounting for 33% of variance in reliable improvement and 22% for reliable recovery.

The proposed study aims at dramatically improving the yield of psychotherapies in the Mental Health Services by combining monitoring and patient-therapist matching strategies. The first will be achieved by implementing Routine Outcome Monitoring (ROM), and the second- by applying a patient-therapist match-re-match procedure during psychotherapy


Condition or disease Intervention/treatment Phase
Anxiety Disorder Affective Disorders Personality Disorders Other: questionnaires Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel, randomized by order, open study, assignment (matching/rematching) supported by monitoring data.
Masking: None (Open Label)
Masking Description: not relevant
Primary Purpose: Health Services Research
Official Title: Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Active Comparator: study group
after monitoring treatment outcomes for 4 weeks, treatment plan or psychotherpist will be changed according to scoring by the director of department.
Other: questionnaires
questionnaire about mental health status during psychotherapy

Placebo Comparator: control group
treatment as usual. treatment counitunes as usual without depending on monitoring treatment outcomes.
Other: questionnaires
questionnaire about mental health status during psychotherapy




Primary Outcome Measures :
  1. OQ-45 (outcome measure) [ Time Frame: up to 14 months ]
    is the most commonly-used outcome measure in psychotherapy. It provides both a measure of weekly change on which the feedback to therapists and patients was based and the criterion measure for classification of a patient into an outcome group on a scale of 0 ("never") to 4 ("always")

  2. SEQ (session outcome) [ Time Frame: up to 14 months ]
    The SEQ-4 validates the WAI-6, and allows the better identification of sessions in which ruptures and repairs occurred. The questionnaire includes 20 bipolar statements ranges on a 7 degrees Likert scale (e.g.:, 1 "sad" to 7 "happy"). the statements refers to 2 dimensions: the dimension of the meeting itself ("the current meeting was ...") and the dimension of feeling ("I feel now ...").

  3. WAI (working alliance) [ Time Frame: up to 14 months ]
    To measure alliance at the end of each session, we will use the patient-version of the Session Alliance Inventory. The SAI is a 6-item short-short version of the Working Alliance Inventory. the questionnaire includes 6 items on a scale of 1 ("does not describe how I feel") to 7("exactly describes how I feel").

  4. HSCL-11 (symptoms) [ Time Frame: up to 14 months ]
    The HSCL-11 will be filled by the patient at the beginning of study and thereafter- every two weeks. it includes 11 items on a scale of 1 ("not at all") to 4("a lot").


Secondary Outcome Measures :
  1. PWB (psychological well-being) [ Time Frame: up to 14 months ]
    The PWB , filled by the patient at the beginning of study and thereafter- every two weeks, in a commonly used questionnaire assessing psychological well-being with acceptable psychometric properties and convergence with prior indexes of well-being. it includes 54 items ranked on a scale of 1("don't agree") to 6 ("very much agree").

  2. Satisfaction from therapy (CSQ) [ Time Frame: up to 14 months ]
    . The CSQ is a standardized measure with strong psychometric properties that could be used to assess general satisfaction across varied health and human services.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All enrolled patients must have a mobile phone capable of hosting the ROM-on-mobile system.
  2. patients with anxiety/ affective (depressive and bi-polar)/ personality disorders

Exclusion Criteria:

  1. Patients exceeding 65 years at their date of admission,
  2. Patients with impaired Hebrew fluency (difficulties in either reading or writing),
  3. Evidence of organic brain syndrome or mental retardation,
  4. Patients with psychotic disorders (e.g. - schizophrenia, delusional disorders)
  5. Evidence of probable need for hospitalization,
  6. Patients admitted only for diagnostic purposes,
  7. Patients unwilling to be enrolled in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608449


Contacts
Layout table for location contacts
Contact: Shlomo Mendalovitch, Dr +972-9-7478532 mendlovic@clalit.org.il

Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Layout table for investigator information
Principal Investigator: Shlomo Mendalovitch, Dr Shalvata mental health hospital

Layout table for additonal information
Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT03608449     History of Changes
Other Study ID Numbers: SHA-005-18
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anxiety Disorders
Personality Disorders
Mood Disorders
Pathologic Processes
Mental Disorders
Psychotropic Drugs