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SchizophrenicsASMASSNCT03917355

Nonverbal Synchrony, Therapeutic Alliance and Treatment Engagement in First Episode Schizophrenia

An observational study of Schizophrenics, run by University Hospital, Montpellier at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenics
What is being tested?
Nonverbal synchrony, therapeutic alliance
How many people
7 participants
Where
1 siteFrance
Study dates
15 Jul 2019to 16 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients with a first psychotic episode

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Montpellier

    Montpellier, 34000

Other trials in France

About this study

Official title: Study of the Link Between Patient/Psychiatrist Motor Synchronization and Treatment Adhesion in Patients With First Psychotic Episode, ASMASS Project

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.

Read the detailed description

Several studies have highlighted the utmost importance of initial medical and psychosocial support during a first psychotic episode. Recent research has shown that non-verbal communication and particularly interpersonal motor synchronization between the patient and his psychiatrist is a key factor in therapeutic alliance. However, such hypothesis have never been tested in terms of treatment adherence neither in a first psychotic episode, nor during a 6-month follow-up. By measuring the interpersonal motor synchronization between the patient and psychiatrist during a video recorded interview at inclusion, month-3 and month-6, the project aims to validate the hypothesis that a high level of interpersonal synchronization should be associated with a high level of therapeutic alliance. This therapeutic alliance being hypothesized as a mediator between synchronization and treatment adherence, the project should show for the first time in a first psychotic episode that the use of reliable and objective variables extracted from the analysis of the synchronization between psychiatrist and patient allows to predict the outcome of therapeutic and treatment alliance.

Conditions
Schizophrenics
Being tested
Nonverbal synchrony, therapeutic alliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nonverbal synchrony, therapeutic allianceBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline

  2. 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).

    Measured: 3 months

  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).

    Measured: 6 months

Secondary outcomes (24)
  1. Therapeutic alliance

    It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand.

    Measured: Baseline

  2. Therapeutic alliance

    It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand.

    Measured: 3 months

  3. Therapeutic alliance

    It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand.

    Measured: 6 months

  4. Positive and Negative Symptom Scale

    The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210).

    Measured: Baseline

  5. Positive and Negative Symptom Scale

    The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210).

    Measured: 3 months

  6. Positive and Negative Symptom Scale

    The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210).

    Measured: 6 months

  7. Clinical Assessment Interview for Negative Symptoms

    CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview.

    Measured: Baseline

  8. Clinical Assessment Interview for Negative Symptoms

    CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview.

    Measured: 3 months

  9. Clinical Assessment Interview for Negative Symptoms

    CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview.

    Measured: 6 months

  10. Functioning Remission of General Schizophrenia

    The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (α=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning.

    Measured: Baseline

  11. Functioning Remission of General Schizophrenia

    The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (α=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning.

    Measured: 3 months

  12. Functioning Remission of General Schizophrenia

    The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (α=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning.

    Measured: 6 months

  13. French National Adult Reading Test

    The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon \& Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ.

    Measured: Baseline

  14. French National Adult Reading Test

    The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon \& Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ.

    Measured: 3 months

  15. French National Adult Reading Test

    The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon \& Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ.

    Measured: 6 months

  16. California Verbal Learning Test

    The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160).

    Measured: Baseline

  17. California Verbal Learning Test

    The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160).

    Measured: 3 months

  18. California Verbal Learning Test

    The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160).

    Measured: 6 months

  19. Trail Making Test

    This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1.

    Measured: Baseline

  20. Trail Making Test

    This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1.

    Measured: 3 months

  21. Trail Making Test

    This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1.

    Measured: 6 months

  22. Energy Motion Analysis

    Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation.

    Measured: Baseline

  23. Energy Motion Analysis

    Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation.

    Measured: 3 months

  24. Energy Motion Analysis

    Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start15 Jul 2019
  3. Primary completion16 Oct 2020
  4. Study completion16 Oct 2020

Why it stopped: Covid-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917355
Sponsor's protocol ID
RECHMPL18_0070
Acronym
ASMASS
Status last verified
Jul 2021
First submitted
26 Mar 2019
Last updated
8 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenics, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Covid-19). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scale of therapeutic compliance (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.

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