NCT03917355

Brief Summary

The quality of the therapeutic intervention in a first psychotic episode is a major challenge for quality and effectiveness of treatment. This project aims to better understand the mechanisms underlying the quality of communication between patient and psychiatrist, especially those related to non-verbal communication. Psychiatrist/patient interpersonal motor synchronization is a reliable index of therapeutic alliance and a predictor of psychotherapy effectiveness. This project aims to show a link between psychiatrist and patient motor synchrony and treatment adherence. This link could be explained by an association between therapeutic alliance and motor synchronization.

Trial Health

57
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Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 26, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

March 26, 2019

Last Update Submit

July 7, 2021

Conditions

Schizophrenics

Outcome Measures

Primary Outcomes (3)

  • Scale of therapeutic compliance

    This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).

    Baseline

  • Scale of therapeutic compliance

    This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).

    3 months

  • Scale of therapeutic compliance

    This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance).

    6 months

Secondary Outcomes (24)

  • Therapeutic alliance

    Baseline

  • Therapeutic alliance

    3 months

  • Therapeutic alliance

    6 months

  • Positive and Negative Symptom Scale

    Baseline

  • Positive and Negative Symptom Scale

    3 months

  • +19 more secondary outcomes

Interventions

Nonverbal synchrony, therapeutic allianceBEHAVIORAL

Association between motor synchronisation in psychiatrist/patient dyad and patient therapeutic adherence in patients with a first psychotic episode will be measured, 6 months after the first post hospitalisation consultation, using video without sound. Nonverbal synchrony, therapeutic alliance and treatment will evaluated.In this purpose, videos of patients and psychiatrist will be made (for all patients included), and the images will be analyzed.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with a first psychotic episode

You may qualify if:

  • Patients after hospitalisation for a first psychotic episode (OMS criteria 1992)
  • Patients fluent in French (spoken and written)
  • Age ≥ 18 years and \< 50 years
  • signed informed consent
  • participation noted in medical files.

You may not qualify if:

  • Inpatients
  • History of brain trauma
  • History of neurological disease
  • Current Electro-convulsive-treatment
  • Drug abuse and dependence (except for tabacco and cannabis)
  • Pregnant/breast feeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Interventions

Therapeutic Alliance

Intervention Hierarchy (Ancestors)

Psychotherapeutic ProcessesPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 17, 2019

Study Start

July 15, 2019

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)