NCT03608449

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 8, 2018

Last Update Submit

July 23, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • OQ-45 (outcome measure)

    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")

    up to 14 months

  • SEQ (session outcome)

    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 ...").

    up to 14 months

  • WAI (working alliance)

    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").

    up to 14 months

  • HSCL-11 (symptoms)

    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").

    up to 14 months

Secondary Outcomes (2)

  • PWB (psychological well-being)

    up to 14 months

  • Satisfaction from therapy (CSQ)

    up to 14 months

Study Arms (2)

study group

ACTIVE COMPARATOR

after monitoring treatment outcomes for 4 weeks, treatment plan or psychotherpist will be changed according to scoring by the director of department.

Other: questionnaires

control group

PLACEBO COMPARATOR

treatment as usual. treatment counitunes as usual without depending on monitoring treatment outcomes.

Other: questionnaires

Interventions

questionnaire about mental health status during psychotherapy

control groupstudy group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersMood DisordersPersonality Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Shlomo Mendalovitch, Dr

    Shalvata mental health hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shlomo Mendalovitch, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
not relevant
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel, randomized by order, open study, assignment (matching/rematching) supported by monitoring data.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2018

First Posted

August 1, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

August 1, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

no plan