NCT04017676

Brief Summary

Psychotherapy is one of the cornerstones in public and private mental health services. Despite the tremendous investment in psychotherapy, its efficiency ranges from 40% to 60%. Given the Mental health Reform (2015), aimed at increasing the quality, availability, and accessibility of mental health services, there is an urgent need to manage and maximize psychotherapy services in Israel.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 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 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

July 9, 2019

Last Update Submit

July 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in OQ45

    The primary outcome measure of the study is the OQ-45 (Lambert, M. J., Gregersen, A.T., Burlingame, G.M. (2004). The Outcome Questionnaire-45 The use of psychological testing for treatment planning and outcomes assessment: Volume 3: Instruments for adults (3rd ed) (pp. 191-234). Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers).

    Initiation, Week 4, Week 7, Week 20

Study Arms (2)

Control group

NO INTERVENTION

The first group will be under the usual treatment conditions (TAU)

Experimental group

EXPERIMENTAL

The second group will be exposed to a multidisciplinary therapeutic program that has a monitoring component and after two months an intervening component will be.

Other: Supervision assissted by measures

Interventions

In the weeks 10 and 13, about 72 hours after the meeting scheduled for that week, and before the next therapeutic session, there will be a structured training session (based on the recommendations of Krägeloh et al., 2015), based on information in the literature about the various questionnaires

Experimental group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Included are patients over the age of 18 years who have agreed to participate in the study, were found suitable for psychotherapeutic treatment and are treated with the attending clinician for at least two months.

You may not qualify if:

  • Patients who (due to cognitive impairment, language gaps, etc.) are not able to complete questionnaires with little help will not be included in the study. In order to minimize the effect of external variables, patients who, in the opinion of the clinician, are expected to undergo significant pharmacological changes (change in non-sleeping drugs or occasional sedatives) will not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Shlomo Mendlovic, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A multicenter, randomized, controlled study with a group comparison and a program trial, in which the subjects are recruited according to a systematic allocation by order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 12, 2019

Study Start

October 1, 2020

Primary Completion

January 1, 2021

Study Completion

April 1, 2021

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share