NCT04125030

Brief 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 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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
suspended

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

Study Start

First participant enrolled

August 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

October 8, 2019

Last Update Submit

October 11, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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).

    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).

    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).

    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).

    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).

    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).

    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).

    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).

    9 months

Secondary Outcomes (1)

  • Patient Experience : organizational recovery

    9 months

Interventions

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).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients diagnosed with schizophrenia and psychotic disorders * Patients diagnosed with Mood disorders

You may qualify if:

  • Participants of the Signature Bank who completed at least T2.

You may not qualify if:

  • Patients with learning disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CR-IUSMM

Montreal, Quebec, H1N 3M5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25885779BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersMood Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jean-Francois Pelletier, PhD

    IUSMM Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 14, 2019

Study Start

August 5, 2019

Primary Completion

March 13, 2020

Study Completion

October 1, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations