Psychotic DisordersNCT04125030
Convergent and Concurrent Validity Between Clinical Recovery and Personal-civic Recovery in Mental Health
An observational study of Psychotic Disorders and Mood Disorders, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
Trial summary
Several instruments have been developed by clinicians and academics specialized in mental health and psychiatry to assess clinical recovery in terms of symptom reduction. Based on their life narratives, measurement tools have also been developed and validated through participatory research programs by persons living… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Mood Disorders
- What is being tested?
- Validation of questionnaires
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2019to Oct 2020
- How long will I take part?
- 2 Years
- 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 65 years
- All sexes
- Adult, Older adult
Study population: * Patients diagnosed with schizophrenia and psychotic disorders * Patients diagnosed with Mood disorders
Who may be able to join
- Participants of the Signature Bank who completed at least T2.
Who cannot join
- Patients with learning disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Instruments Validation and Correlational Explorations Between Clinical Recovery and Personal Recovery for the Evaluation of a Brief Intervention by Peer Support Workers in the Province of Quebec, Canada
Several instruments have been developed by clinicians and academics specialized in mental health and psychiatry to assess clinical recovery in terms of symptom reduction. Based on their life narratives, measurement tools have also been developed and validated through participatory research programs by persons living with mental health problems or illnesses to assess a more personal experience of recovery as a way of leaving a meaningful and satisfying life despite and beyond ongoing disorders and symptoms of mental illness. Other instruments have also been developed to assess the degree to which mental health and psychiatric institutions are recovery-oriented. The overall aim of this project is to explore correlations between clinical recovery, personal recovery and this latter organizational recovery.
Read the detailed description
The "signatures" of mental health problems or illnesses (MHPIs) is a term formulated by the National Institute of Mental Health (NIMH) to designate the broad range of genetic, biological, psychological, and social factors that may "sign" a specific mental disorder, depending on an individual's sex, history, lifestyle habits, and so on. In 2010, the Research Center of the Mental Health University Institute of Montreal (IUSMM) decided to develop the "Signature Bank" project for the collection of biological and dimensional signatures from all patients with MHPIs of the IUSMM (catchment area of about 600,000 inhabitants). Over 4,000 patients are treated annually at the IUSMM, while an additional 2,000 patients per year are treated by means of outpatient or ambulatory services. These activities provide us with one of the largest populations of psychiatric patients in Canada. This research project is based on the extensive involvement of the IUSMM-hospital site in the attempt to establish an exclusive niche for discoveries in the signatures of mental illnesses. By collaborating with the Research Centre, IUSMM-hospital managers have contributed to the implementation of this large-scale project that aims at measuring the genetic, biological, psychological, and social signatures of people living with MHPIs who use the IUSMM-hospital's clinical services, and who consent to taking part in this longitudinal research initiative. The goal of is study is to better understand not only the signatures of MHPIs, but that of recovery in mental health, and as reported by patients living with psychiatric disorders who will additionally fill out the French Recovery Assessment Scale (RAS), Recovery Self-Assessment (RSA) and Citizenship Measure (CM). Participants in the Signature Bank are routinely approached and recruited by a Research Nurse at their admission to the Psychiatric Emergency Department (T1) of the IUSMM. As of March 2019, 1862 eligible participants from the psychiatric emergency of the IUSMM have been approached. Of this number, 1218 agreed to participate and thus completed at least T1 of the Signature study. For all participants, the same measures are repeated at discharge (T2), at the first follow up at an outpatient clinic (T3), and finally (T4) when treatment ends or 12 months after T3. Our sample is characterized by individuals with psychotic disorders (N=166), or mood disorders (N=186), for a total of 352 patients who completed T3 and/or T4. All participants signed a detailed consent form, and the study was approved by the local ethics committee in accordance with the Declaration of Helsinki. Research Nurses collected patient's psychiatric diagnoses from medical records. They were established by psychiatrists on the ward, and coded according to the World Health Organisation International Classification of Disease (ICD-10). This study will use 2 of the categories of mental or behavioural disorder (F00-F99): 1) Schizophrenia and psychotic disorders (F20-F29), and 2) Mood disorders (F30-F39) who have enrolled in the Signature Bank for longitudinal studies and who have thus already completed questionnaires for clinical evaluation purposes (clinical recovery). Those who accept to participate in this study will further complete the RAS, the CM, and the RSA, which was developed to gauge the degree to which programs implement recovery-oriented practices and to identify strengths and areas of improvement as agencies strive to offer recovery-oriented care. Two specific research objectives are pursued. Firstly: measuring correlational relations between dimensions of personal recovery (RAS and CM), and levels of anxiety, depression, dependence, psychosis, and social functioning (clinical recovery). Secondly: validation of the psychometric properties of the French version of the RSA (organizational recovery). Statistical analyses will be performed to determine internal consistency (Cronbach alphas for each of the subscales), and construct validity (confirmatory or exploratory factor analyzes). Our power calculation has determined that 200 participants will be needed to test measurement invariance for sex and main psychiatric diagnosis (psychotic or mood disorders) in order to detect significant correlations with a Type I error of 5% and a power of 80%. Signature Bank participants will be contacted to complete i) the RAS (24 items, 5-point Likert scale), ii) the CM (23 items, 5-point Likert scale), and the iii) the RSA for consumers (32 items, 5-point Likert scale). These participants have already completed these other measures (clinical recovery): iv-Anxiety: Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6) (6 items); v- Depression: Depression Patient Health Questionnaire (PHQ-9) (9 items) ; vi- Alcohol Dependence: Alcohol Use Disorders Identification Test (AUDIT-10) (10 items) ; vii- Drug Dependence: Drug Abuse Screening Test (DAST-10) (10 items) ; viii- Psychosis : Psychosis Screening Questionnaire (PSQ 12 items) ; ix- Social functioning : World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12 items).
Each patient diagnosed with F20-F39 disorders and who have completed at least T2 will be contacted by phone and asked to additionally fill out the RSA, RAS and CM. Those who will accept to be contacted will be invited to come to the IUSMM where they will be met by a Research Assistant. They will first read and sign the additional Information and Consent Form specific to this study or ask further questions before doing so. Secondly, they will fill out the RSA, RAS and CM on a touch screen device. Data will be stored on the Signature Bank secured server. If necessary, future new participants who will have completed T2 will be contacted in the same way until the required number of participants is reached. There are typically 60 to 80 new participants per month to the Signature Bank. Test-retest reliability will be investigated, as well as internal consistency, construct validity of these RSA, RAS and CM tools, correlations between their subscales and those of anxiety, depression, substance misuse, psychosis, and social functioning measures, in and across psychiatric diagnoses, and sex. The same i-iv measures will be used in a future project to assess the effect of a brief intervention by Peer Support Workers (PSW) with a control group. A Randomized Control Trial with future IUSMM patients who will have accepted to be enrolled in the Signature Bank will be proposed to compare treatment as usual to treatment as usual plus the PSW intervention.
- Conditions
- Psychotic Disorders, Mood Disorders
- Being tested
- Validation of questionnaires
- Medical subject headings
- Psychotic Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of questionnairesOther
Participants will complete i) the RAS (24 items, 5-point Likert scale), ii) the CM (23 items, 5-point Likert scale), and the iii) the RSA for consumers (32 items, 5-point Likert scale). These participants have already completed these other measures (clinical recovery): iv-Anxiety: Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6) (6 items); v- Depression: Depression Patient Health Questionnaire (PHQ-9) (9 items) ; vi- Alcohol Dependence: Alcohol Use Disorders Identification Test (AUDIT-10) (10 items) ; vii- Drug Dependence: Drug Abuse Screening Test (DAST-10) (10 items) ; viii- Psychosis : Psychosis Screening Questionnaire (PSQ 12 items) ; ix- Social functioning : World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12 items).
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patients' current status : anxiety (clinical recovery)
Participating patients will fill out the Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6). This is a 6-item questionnaire with 4-point Likert scales (1-2-3-4). Higher scores are positively correlated with higher levels of anxiety. Minimum score = 6 : maximum score = 24.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Assessment of patients' current status : depression (clinical recovery)
Participating patients will fill out the Depression Patient Health Questionnaire (PHQ-9). This is a 9-item questionnaire with 4-point Likert scales (0-1-2-3). Higher scores are positively correlated with higher levels of depression. Minimum score = 0 : maximum score = 27.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Assessment of patients' current status : alcohol dependence (clinical recovery)
Participating patients will fill out the Alcohol Use Disorders Identification Test (AUDIT-10). This is a 10-item questionnaire with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of alcohol dependence. Minimum score = 0 : maximum score = 40.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Assessment of patients' current status : drug dependence (clinical recovery)
Participating patients will fill out the Drug Abuse Screening Test (DAST-10). This is a 10-item questionnaire with no-yes answers (0-1). Higher scores are positively correlated with higher levels of drog dependence. Minimum score = 0 : maximum score = 10.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Assessment of patients' current status : psychosis (clinical recovery)
Psychosis Screening Questionnaire (PSQ 12 items) with no-unsure-yes answers (1-2-3). Higher scores are positively correlated with higher levels of psychosis. Minimum score = 12 : maximum score = 36.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Assessment of patients' current status : social functioning (clinical recovery)
Participating patients will fill out the World Health Organization Disability Assessment Schedule (WHODAS 2.0). This is a 12-item questionnaire with 5-point Likert scales (0-1-2-3-4). Lower scores are positively correlated with higher levels of social functioning. Minimum score = 0 : maximum score = 48.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Assessment of patients' current status : recovery (personal recovery)
Participating patients will fill out the Recovery Assesment Scale (RAS). This is a 24-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of recovery. Minimum score = 24 : maximum score = 120.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Assessment of patients' current status : citizenship (personal recovery)
Participating patients will fill out the Citizenship Measure (CM). This is a 23-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of citizenship. Minimum score = 23 : maximum score = 115.
Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Measured: 9 months
Secondary outcomes (1)
Patient Experience : organizational recovery
Participating patients will fill out the Recovery Self-Assessment (RSA-for consumers), to assess their current experience of mental healthcare. This tool was developed to gauge the degree to which programs implement recovery-oriented practices and to identify strengths and areas of improvement as agencies strive to offer recovery-oriented care. This is a 32-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of recovery-oriented care. Minimum score = 32 : maximum score = 160.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start5 Aug 2019
- Primary completion13 Mar 2020
- Study completionOct 2020 (estimated)
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Jean-Francois Pelletier, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Investigators
- Jean-Francois Pelletier, PhD, Principal investigator, IUSMM Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125030
- Sponsor's protocol ID
- 2020-1948
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pelletier JF, Corbiere M, Lecomte T, Briand C, Corrigan P, Davidson L, Rowe M. Citizenship and recovery: two intertwined concepts for civic-recovery. BMC Psychiatry. 2015 Mar 4;15:37. doi: 10.1186/s12888-015-0420-2.
PubMed 25885779
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instruments Validation and Correlational Explorations Between Clinical Recovery and Personal Recovery for the Evaluation of a Brief Intervention by Peer Support Workers in the Province of Quebec, Canada
- ClinicalTrials.gov ID
- NCT04125030
- Acronym / sponsor ID
- 2020-1948
- Conditions
- Psychotic Disorders, Mood Disorders
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19 pandemic
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de MontréalUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- Oct 2020 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several instruments have been developed by clinicians and academics specialized in mental health and psychiatry to assess clinical recovery in terms of symptom reduction. Based on their life narratives, measurement tools have also been developed and validated through participatory research programs by persons living with mental health problems or illnesses to assess a more personal experience of recovery as a way of leaving a meaningful and satisfying life despite and beyond ongoing disorders and symptoms of mental illness. Other instruments have also been developed to assess the degree to which mental health and psychiatric institutions are recovery-oriented. The overall aim of this project is to explore correlations between clinical recovery, personal recovery and this latter organizational recovery.
Detailed description
The "signatures" of mental health problems or illnesses (MHPIs) is a term formulated by the National Institute of Mental Health (NIMH) to designate the broad range of genetic, biological, psychological, and social factors that may "sign" a specific mental disorder, depending on an individual's sex, history, lifestyle habits, and so on. In 2010, the Research Center of the Mental Health University Institute of Montreal (IUSMM) decided to develop the "Signature Bank" project for the collection of biological and dimensional signatures from all patients with MHPIs of the IUSMM (catchment area of about 600,000 inhabitants). Over 4,000 patients are treated annually at the IUSMM, while an additional 2,000 patients per year are treated by means of outpatient or ambulatory services. These activities provide us with one of the largest populations of psychiatric patients in Canada. This research project is based on the extensive involvement of the IUSMM-hospital site in the attempt to establish an exclusive niche for discoveries in the signatures of mental illnesses. By collaborating with the Research Centre, IUSMM-hospital managers have contributed to the implementation of this large-scale project that aims at measuring the genetic, biological, psychological, and social signatures of people living with MHPIs who use the IUSMM-hospital's clinical services, and who consent to taking part in this longitudinal research initiative. The goal of is study is to better understand not only the signatures of MHPIs, but that of recovery in mental health, and as reported by patients living with psychiatric disorders who will additionally fill out the French Recovery Assessment Scale (RAS), Recovery Self-Assessment (RSA) and Citizenship Measure (CM). Participants in the Signature Bank are routinely approached and recruited by a Research Nurse at their admission to the Psychiatric Emergency Department (T1) of the IUSMM. As of March 2019, 1862 eligible participants from the psychiatric emergency of the IUSMM have been approached. Of this number, 1218 agreed to participate and thus completed at least T1 of the Signature study. For all participants, the same measures are repeated at discharge (T2), at the first follow up at an outpatient clinic (T3), and finally (T4) when treatment ends or 12 months after T3. Our sample is characterized by individuals with psychotic disorders (N=166), or mood disorders (N=186), for a total of 352 patients who completed T3 and/or T4. All participants signed a detailed consent form, and the study was approved by the local ethics committee in accordance with the Declaration of Helsinki. Research Nurses collected patient's psychiatric diagnoses from medical records. They were established by psychiatrists on the ward, and coded according to the World Health Organisation International Classification of Disease (ICD-10). This study will use 2 of the categories of mental or behavioural disorder (F00-F99): 1) Schizophrenia and psychotic disorders (F20-F29), and 2) Mood disorders (F30-F39) who have enrolled in the Signature Bank for longitudinal studies and who have thus already completed questionnaires for clinical evaluation purposes (clinical recovery). Those who accept to participate in this study will further complete the RAS, the CM, and the RSA, which was developed to gauge the degree to which programs implement recovery-oriented practices and to identify strengths and areas of improvement as agencies strive to offer recovery-oriented care. Two specific research objectives are pursued. Firstly: measuring correlational relations between dimensions of personal recovery (RAS and CM), and levels of anxiety, depression, dependence, psychosis, and social functioning (clinical recovery). Secondly: validation of the psychometric properties of the French version of the RSA (organizational recovery). Statistical analyses will be performed to determine internal consistency (Cronbach alphas for each of the subscales), and construct validity (confirmatory or exploratory factor analyzes). Our power calculation has determined that 200 participants will be needed to test measurement invariance for sex and main psychiatric diagnosis (psychotic or mood disorders) in order to detect significant correlations with a Type I error of 5% and a power of 80%. Signature Bank participants will be contacted to complete i) the RAS (24 items, 5-point Likert scale), ii) the CM (23 items, 5-point Likert scale), and the iii) the RSA for consumers (32 items, 5-point Likert scale). These participants have already completed these other measures (clinical recovery): iv-Anxiety: Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6) (6 items); v- Depression: Depression Patient Health Questionnaire (PHQ-9) (9 items) ; vi- Alcohol Dependence: Alcohol Use Disorders Identification Test (AUDIT-10) (10 items) ; vii- Drug Dependence: Drug Abuse Screening Test (DAST-10) (10 items) ; viii- Psychosis : Psychosis Screening Questionnaire (PSQ 12 items) ; ix- Social functioning : World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12 items).
Each patient diagnosed with F20-F39 disorders and who have completed at least T2 will be contacted by phone and asked to additionally fill out the RSA, RAS and CM. Those who will accept to be contacted will be invited to come to the IUSMM where they will be met by a Research Assistant. They will first read and sign the additional Information and Consent Form specific to this study or ask further questions before doing so. Secondly, they will fill out the RSA, RAS and CM on a touch screen device. Data will be stored on the Signature Bank secured server. If necessary, future new participants who will have completed T2 will be contacted in the same way until the required number of participants is reached. There are typically 60 to 80 new participants per month to the Signature Bank. Test-retest reliability will be investigated, as well as internal consistency, construct validity of these RSA, RAS and CM tools, correlations between their subscales and those of anxiety, depression, substance misuse, psychosis, and social functioning measures, in and across psychiatric diagnoses, and sex. The same i-iv measures will be used in a future project to assess the effect of a brief intervention by Peer Support Workers (PSW) with a control group. A Randomized Control Trial with future IUSMM patients who will have accepted to be enrolled in the Signature Bank will be proposed to compare treatment as usual to treatment as usual plus the PSW intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Patients diagnosed with schizophrenia and psychotic disorders * Patients diagnosed with Mood disorders
Key inclusion criteria (1 listed)
- Participants of the Signature Bank who completed at least T2.
Key exclusion criteria (1 listed)
- Patients with learning disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of questionnairesParticipants will complete i) the RAS (24 items, 5-point Likert scale), ii) the CM (23 items, 5-point Likert scale), and the iii) the RSA for consumers (32 items, 5-point Likert scale). These participants have already completed these other measures (clinical recovery): iv-Anxiety: Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6) (6 items); v- Depression: Depression Patient Health Questionnaire (PHQ-9) (9 items) ; vi- Alcohol Dependence: Alcohol Use Disorders Identification Test (AUDIT-10) (10 items) ; vii- Drug Dependence: Drug Abuse Screening Test (DAST-10) (10 items) ; viii- Psychosis : Psychosis Screening Questionnaire (PSQ 12 items) ; ix- Social functioning : World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12 items). | Other | – |
Primary outcome
Assessment of patients' current status : anxiety (clinical recovery)
Time frame: 9 months
Participating patients will fill out the Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6). This is a 6-item questionnaire with 4-point Likert scales (1-2-3-4). Higher scores are positively correlated with higher levels of anxiety. Minimum score = 6 : maximum score = 24. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Assessment of patients' current status : depression (clinical recovery)
Time frame: 9 months
Participating patients will fill out the Depression Patient Health Questionnaire (PHQ-9). This is a 9-item questionnaire with 4-point Likert scales (0-1-2-3). Higher scores are positively correlated with higher levels of depression. Minimum score = 0 : maximum score = 27. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Assessment of patients' current status : alcohol dependence (clinical recovery)
Time frame: 9 months
Participating patients will fill out the Alcohol Use Disorders Identification Test (AUDIT-10). This is a 10-item questionnaire with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of alcohol dependence. Minimum score = 0 : maximum score = 40. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Assessment of patients' current status : drug dependence (clinical recovery)
Time frame: 9 months
Participating patients will fill out the Drug Abuse Screening Test (DAST-10). This is a 10-item questionnaire with no-yes answers (0-1). Higher scores are positively correlated with higher levels of drog dependence. Minimum score = 0 : maximum score = 10. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Assessment of patients' current status : psychosis (clinical recovery)
Time frame: 9 months
Psychosis Screening Questionnaire (PSQ 12 items) with no-unsure-yes answers (1-2-3). Higher scores are positively correlated with higher levels of psychosis. Minimum score = 12 : maximum score = 36. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Assessment of patients' current status : social functioning (clinical recovery)
Time frame: 9 months
Participating patients will fill out the World Health Organization Disability Assessment Schedule (WHODAS 2.0). This is a 12-item questionnaire with 5-point Likert scales (0-1-2-3-4). Lower scores are positively correlated with higher levels of social functioning. Minimum score = 0 : maximum score = 48. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Assessment of patients' current status : recovery (personal recovery)
Time frame: 9 months
Participating patients will fill out the Recovery Assesment Scale (RAS). This is a 24-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of recovery. Minimum score = 24 : maximum score = 120. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
Assessment of patients' current status : citizenship (personal recovery)
Time frame: 9 months
Participating patients will fill out the Citizenship Measure (CM). This is a 23-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of citizenship. Minimum score = 23 : maximum score = 115. Data will be aggregated for statistical analyses (convergent validation and confirmatory factor analyses) and measurement of invariance for sex (male/female) and main psychiatric diagnosis (psychotic/mood disorders).
1 secondary outcome
Patient Experience : organizational recovery
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 25885779Pelletier JF, Corbiere M, Lecomte T, Briand C, Corrigan P, Davidson L, Rowe M. Citizenship and recovery: two intertwined concepts for civic-recovery. BMC Psychiatry. 2015 Mar 4;15:37. doi: 10.1186/s12888-015-0420-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Francois Pelletier, PhD principal investigator
IUSMM Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders and Mood Disorders, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
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 1 inclusion and 1 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: paused, as of the sponsor's last update on 14 Oct 2020. 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 Canada. 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?
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?
Assessment of patients' current status : anxiety (clinical recovery) (time frame: 9 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125030, which also lists 1 linked publication.
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 14 Oct 2020.