Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05116514
Other study ID # PREPS/2018/AS-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 27, 2021
Est. completion date November 2028

Study information

Verified date July 2023
Source Centre Hospitalier Universitaire de Nimes
Contact Aurélie Schandrin
Phone 04.66.68.34.26
Email aurelie.schandrin@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration


Recruitment information / eligibility

Status Recruiting
Enrollment 256
Est. completion date November 2028
Est. primary completion date September 2028
Accepts healthy volunteers No
Gender All
Age group 16 Years to 30 Years
Eligibility Inclusion Criteria: - The patient or their close relative must have given their free and informed consent and signed the consent form - The patient must be a member or beneficiary of a health insurance plan - The patient is available for a 3-year follow-up. - Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by: - Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ; - Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry); - A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features. - Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service. - At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission. Exclusion Criteria: - The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study - The subject, or one of the parents for minor patients, refuses to sign the consent - It is impossible to give the subject informed information - The patient is under safeguard of justice or state guardianship - The patients has an IQ less than or equal to 55 - The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition - The patient is pregnant or breastfeeding

Study Design


Intervention

Other:
Case management
Regular and personalized follow-up by a case manager using a "case management" approach, updated every 3 months

Locations

Country Name City State
France CH Saint Marie Clermont-Ferrand Clermont-Ferrand
France CHU de Montpellier Montpellier
France CHU Nice Nice
France CHU de Nîmes Nîmes
France Centre Hospitalier Léon-Jean Grégory Thuir
France CHU de TOULOUSE Toulouse Choisir Une Région

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of patients with recurrence of psychotic episode at least once between groups Recurrence of the psychotic episode will be defined as psychiatric hospitalization with a diagnosis of psychotic disorder and/or the presence of positive psychotic symptoms according to the Positive and Negative Symptom Scale (PANSS) = 4 for item P1 (delusions) and/or P2 (conceptual disorganization) and/or P3 (hallucination)) over a period of at least one week. 3 years
Secondary Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient number 1 year
Secondary Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient number 2 years
Secondary Evaluate the impact of the intervention on the number of recurrences of psychiatric hospitalization per patient number 3 years
Secondary Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient number 1 year
Secondary Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient number 2 years
Secondary Evaluate the impact of the intervention on the number of psychiatric hospitalizations per patient number 3 years
Secondary Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient days/weeks/months 1 year
Secondary Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient days/weeks/months 2 years
Secondary Evaluate the impact of the intervention on the duration of psychiatric hospitalization per patient days/weeks/months 3 years
Secondary Percentage per patient of medical and caregiving appointments honored between groups Inclusion
Secondary Percentage per patient of medical and caregiving appointments honored between groups 6 months
Secondary Percentage per patient of medical and caregiving appointments honored between groups 1 year
Secondary Percentage per patient of medical and caregiving appointments honored between groups 18 months
Secondary Percentage per patient of medical and caregiving appointments honored between groups 2 years
Secondary Percentage per patient of medical and caregiving appointments honored between groups 2.5 years
Secondary Percentage per patient of medical and caregiving appointments honored between groups 3 years
Secondary Type of hospital admission (voluntary versus involuntary) between groups % voluntary versus involuntary Inclusion
Secondary Type of hospital admission (voluntary versus involuntary) between groups % voluntary versus involuntary 6 months
Secondary Type of hospital admission (voluntary versus involuntary) between groups % voluntary versus involuntary 1 year
Secondary Type of hospital admission (voluntary versus involuntary) between groups % voluntary versus involuntary 18 months
Secondary Type of hospital admission (voluntary versus involuntary) between groups % voluntary versus involuntary 2 years
Secondary Type of hospital admission (voluntary versus involuntary) between groups % voluntary versus involuntary 2.5 years
Secondary Type of hospital admission (voluntary versus involuntary) between groups % voluntary versus involuntary 3 years
Secondary Unscheduled discharge from care between groups Defined by a break in follow-up organized by the referring care team for more than 30 days Inclusion
Secondary Unscheduled discharge from care between groups Defined by a break in follow-up organized by the referring care team for more than 30 days 6 months
Secondary Unscheduled discharge from care between groups Defined by a break in follow-up organized by the referring care team for more than 30 days 1 year
Secondary Unscheduled discharge from care between groups Defined by a break in follow-up organized by the referring care team for more than 30 days 18 months
Secondary Unscheduled discharge from care between groups Defined by a break in follow-up organized by the referring care team for more than 30 days 2 years
Secondary Unscheduled discharge from care between groups Defined by a break in follow-up organized by the referring care team for more than 30 days 2.5 years
Secondary Unscheduled discharge from care between groups Defined by a break in follow-up organized by the referring care team for more than 30 days 3 years
Secondary Treatment compliance between groups item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) Inclusion
Secondary Treatment compliance between groups item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) 6 months
Secondary Treatment compliance between groups item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) 1 year
Secondary Treatment compliance between groups item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) 18 months
Secondary Treatment compliance between groups item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) 2 years
Secondary Treatment compliance between groups item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) 2.5 years
Secondary Treatment compliance between groups item 13 of the Health of the Nation Outcome Scales (HoNOS, hetero-assessment) 3 years
Secondary Adherence to treatment Medication Adherence Rating Scale (MARS, self-administered questionnaire) 1 year
Secondary Adherence to treatment Medication Adherence Rating Scale (MARS, self-administered questionnaire) 2 years
Secondary Adherence to treatment Medication Adherence Rating Scale (MARS, self-administered questionnaire) 3 years
Secondary Therapeutic alliance Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire) 1 year
Secondary Therapeutic alliance Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire) 2 years
Secondary Therapeutic alliance Working Alliance Inventory-Short Revised (WAI-SR, self-administered questionnaire) 3 years
Secondary Patient awareness of disorders and of the need for treatment Birchwood Insight Scale (BIS, self-administered questionnaire) 1 year
Secondary Patient awareness of disorders and of the need for treatment Birchwood Insight Scale (BIS, self-administered questionnaire) 2 years
Secondary Patient awareness of disorders and of the need for treatment Birchwood Insight Scale (BIS, self-administered questionnaire) 3 years
Secondary Assessment of addictive comorbidities semi-structured clinical interview for DSM (SCID) Inclusion
Secondary Assessment of addictive comorbidities semi-structured clinical interview for DSM (SCID) 3 years
Secondary Assessment of tobacco, alcohol and drug use Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Every 6 months from inclusion
Secondary Evaluation of the clinical impact of the intervention between groups Clinical Global Impression questionnaire (CGI) Every 6 months from inclusion
Secondary Psychotic and general symptoms Positive and Negative Symptom Scale (PANSS) Every 6 months from inclusion
Secondary Depressive symptoms Calgary Depression Scale for Schizophrenia (CDSS) Every 6 months from inclusion
Secondary Self- and hetero-aggressive behaviors according to Health of the Nation Outcome Scales (HoNOS) items 1 and 2 Every 6 months from inclusion
Secondary Reported adverse events death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS Inclusion
Secondary Reported adverse events death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS 6 months
Secondary Reported adverse events death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS 1 year
Secondary Reported adverse events death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS 18 months
Secondary Reported adverse events death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS 2 years
Secondary Reported adverse events death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS 2.5 years
Secondary Reported adverse events death by suicide, attempted suicide or self-injurious acts, hetero-aggressive acts according to the medical record and investigated if score greater than or equal to 3 on items 1 and 2 of the HoNOS 3 years
Secondary Current suicidal ideations Calgary Depression Scale for Schizophrenia (CDSS) Inclusion
Secondary Current suicidal ideations Calgary Depression Scale for Schizophrenia (CDSS) 6 months
Secondary Current suicidal ideations Calgary Depression Scale for Schizophrenia (CDSS) 1 year
Secondary Current suicidal ideations Calgary Depression Scale for Schizophrenia (CDSS) 18 months
Secondary Current suicidal ideations Calgary Depression Scale for Schizophrenia (CDSS) 2 years
Secondary Current suicidal ideations Calgary Depression Scale for Schizophrenia (CDSS) 2.5 years
Secondary Current suicidal ideations Calgary Depression Scale for Schizophrenia (CDSS) 3 years
Secondary Assess the impact of the intervention on socio-professional functioning and quality of life Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation Inclusion
Secondary Assess the impact of the intervention on socio-professional functioning and quality of life Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation 6 months
Secondary Assess the impact of the intervention on socio-professional functioning and quality of life Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation 1 year
Secondary Assess the impact of the intervention on socio-professional functioning and quality of life Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation 18 months
Secondary Assess the impact of the intervention on socio-professional functioning and quality of life Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation 2 years
Secondary Assess the impact of the intervention on socio-professional functioning and quality of life Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation 2.5 years
Secondary Assess the impact of the intervention on socio-professional functioning and quality of life Socio-demographic data updated every 6 months: living conditions (housing, entourage, income), level of education and/or professional situation 3 years
Secondary Social and occupational functioning Social and Occupational Functioning Assessment Scale (SOFAS) Inclusion
Secondary Social and occupational functioning Social and Occupational Functioning Assessment Scale (SOFAS) 6 months
Secondary Social and occupational functioning Social and Occupational Functioning Assessment Scale (SOFAS) 1 year
Secondary Social and occupational functioning Social and Occupational Functioning Assessment Scale (SOFAS) 18 months
Secondary Social and occupational functioning Social and Occupational Functioning Assessment Scale (SOFAS) 2 years
Secondary Social and occupational functioning Social and Occupational Functioning Assessment Scale (SOFAS) 2.5 years
Secondary Social and occupational functioning Social and Occupational Functioning Assessment Scale (SOFAS) 3 years
Secondary Social functioning Health of the Nation Outcome Scales Inclusion
Secondary Social functioning Health of the Nation Outcome Scales 6 months
Secondary Social functioning Health of the Nation Outcome Scales 1 year
Secondary Social functioning Health of the Nation Outcome Scales 18 months
Secondary Social functioning Health of the Nation Outcome Scales 2 years
Secondary Social functioning Health of the Nation Outcome Scales 2.5 years
Secondary Social functioning Health of the Nation Outcome Scales 3 years
Secondary Psychosocial functioning Quality of Life Scale (QLS) - semi-structured interview Inclusion
Secondary Psychosocial functioning Quality of Life Scale (QLS) - semi-structured interview 6 months
Secondary Psychosocial functioning Quality of Life Scale (QLS) - semi-structured interview 1 year
Secondary Psychosocial functioning Quality of Life Scale (QLS) - semi-structured interview 18 months
Secondary Psychosocial functioning Quality of Life Scale (QLS) - semi-structured interview 2 years
Secondary Psychosocial functioning Quality of Life Scale (QLS) - semi-structured interview 2.5 years
Secondary Psychosocial functioning Quality of Life Scale (QLS) - semi-structured interview 3 years
Secondary Functioning Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire Inclusion
Secondary Functioning Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire 6 months
Secondary Functioning Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire 1 year
Secondary Functioning Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire 18 months
Secondary Functioning Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire 2 years
Secondary Functioning Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire 2.5 years
Secondary Functioning Schizophrenia Quality of Life Scale Revision 4: self-administered questionnaire 3 years
Secondary Quality of life of users (patient and family) World Health Organization Quality of Life brief (WHOQOL-brief) 1 year
Secondary Quality of life of users (patient and family) World Health Organization Quality of Life brief (WHOQOL-brief) 2 years
Secondary Quality of life of users (patient and family) World Health Organization Quality of Life brief (WHOQOL-brief) 3 years
Secondary Health-related quality of life EuroQol-5D 3 level version (EQ-5D-35L) 1 year
Secondary Health-related quality of life EuroQol-5D 3 level version (EQ-5D-35L) 2 years
Secondary Health-related quality of life EuroQol-5D 3 level version (EQ-5D-35L) 3 years
Secondary Quality of life of relatives caregiver schizophrenia quality of life questionnaire (S-CGQoL) 1 year
Secondary Quality of life of relatives caregiver schizophrenia quality of life questionnaire (S-CGQoL) 2 years
Secondary Quality of life of relatives caregiver schizophrenia quality of life questionnaire (S-CGQoL) 3 years
Secondary Cost-outcome type ratio the ratio of the difference in costs between the two strategies divided by the difference in QALYs. This ratio measures the cost per life-year gained in full health, i.e. a cost per QALY. This indicator is obtained by weighting the time spent in each health state h by the utility of that health state measured by the EQ-5D 3 years
Secondary Cost of care assessed from a community perspective (health care system, out-of-pocket expenses, caregivers) 3 years
Secondary Budget impact analysis between strategies National estimates of avoided costs, care consumption and the cost of implementing the system in the two management strategies 3 years
Secondary Psychiatric assessment Structured Clinical Interview for DSM Inclusion
Secondary Psychiatric assessment Structured Clinical Interview for DSM 3 years
Secondary Patient age Inclusion
Secondary Patient sex Inclusion
Secondary Current patient professional/training situation working or studying Over the study until 3 years
Secondary Financial situation Over the study until 3 years
Secondary Care pathways taken by patient specialist care sought Over the study until 3 years
Secondary Duration of non-treated psychosis Interval between start of psychotic symptoms and start of sufficient antipsychotic treatment Inclusion
Secondary Personal and family psychiatric history Inclusion
Secondary Social and academic function Premorbid Adjustment Scale Inclusion
Secondary Medical treatment received Until 3 years
Secondary Cerebral imagery Normal/abnormal Inclusion
Secondary Cerebral imagery Normal/abnormal 1 year
Secondary Cerebral imagery Normal/abnormal 2 years
Secondary IQ profile Homogenous/heterogenous Inclusion
Secondary IQ profile Homogenous/heterogenous 1 year
Secondary IQ profile Homogenous/heterogenous 2 years
Secondary IQ value Inclusion
Secondary IQ value 1 year
Secondary IQ value 2 years
Secondary BMI kg/m2 Inclusion
Secondary BMI kg/m2 1 year
Secondary BMI kg/m2 2 years
Secondary Fasting glycemia mmol/l Inclusion
Secondary Fasting glycemia mmol/l 1 year
Secondary Fasting glycemia mmol/l 2 years
Secondary Lipid assessment Normal/abnormal Inclusion
Secondary Lipid assessment Normal/abnormal 1 year
Secondary Lipid assessment Normal/abnormal 2 years
Secondary Whole blood count Normal/abnormal Inclusion
Secondary Whole blood count Normal/abnormal 1 year
Secondary Whole blood count Normal/abnormal 2 years
Secondary Electrolytes Normal/abnormal Inclusion
Secondary Electrolytes Normal/abnormal 1 year
Secondary Electrolytes Normal/abnormal 2 years
Secondary Neurological exam Normal/abnormal Inclusion
Secondary Neurological exam Normal/abnormal 1 year
Secondary Neurological exam Normal/abnormal 2 years
Secondary Cardiovascular exam Normal/abnormal Inclusion
Secondary Cardiovascular exam Normal/abnormal 1 year
Secondary Cardiovascular exam Normal/abnormal 2 years
Secondary Morphological exam Normal/abnormal Inclusion
Secondary Morphological exam Normal/abnormal 1 year
Secondary Morphological exam Normal/abnormal 2 years
Secondary Hepatic exam Normal/abnormal Inclusion
Secondary Hepatic exam Normal/abnormal 1 year
Secondary Hepatic exam Normal/abnormal 2 years
Secondary Presence of neurometabolic disease Yes/no Inclusion
Secondary Presence of neurometabolic disease Yes/no 1 year
Secondary Presence of neurometabolic disease Yes/no 2 years
Secondary Electrocardiogram Normal/abnormal Inclusion
Secondary Electrocardiogram Normal/abnormal 1 year
Secondary Electrocardiogram Normal/abnormal 2 years
Secondary C-reactive protein mg/l Inclusion
Secondary C-reactive protein mg/l 1 year
Secondary C-reactive protein mg/l 2 years
Secondary thyroid-stimulating hormone mUI/l Inclusion
Secondary thyroid-stimulating hormone mUI/l 1 year
Secondary thyroid-stimulating hormone mUI/l 2 years
Secondary Cortisol nmol/l Inclusion
Secondary Cortisol nmol/l 1 year
Secondary Cortisol nmol/l 2 years
Secondary Adverse events Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other Inclusion
Secondary Adverse events Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other 1 year
Secondary Adverse events Any of the following (yes/no): Neurological symptoms, overweight, metabolic syndrome, sexual dysfunction, fatigue, salivation dysfunction, other 2 years
Secondary Non-medical treatment received Psychosocial/psychotherapy interventions Until 3 years
Secondary In the experimental group: case management according to good practice guidelines EPPIC Model Integrity Tool (80 items with subscores) End of follow-up (3 years)
Secondary In the experimental group: Conformity of case management Index of Fidelity to Assertive Community Treatment (16 criteria of conformity for three dimensions) End of study (5 years)
Secondary In the experimental group: conformity to TIDieR checklist in each patient TIDieR checklist-patient Month 3
Secondary In the experimental group: conformity to TIDieR checklist in each patient TIDieR checklist-patient Month 6
Secondary In the experimental group: conformity to TIDieR checklist in each patient TIDieR checklist-patient 1 year
Secondary In the experimental group: conformity to TIDieR checklist in each patient TIDieR checklist-patient 18 Months
Secondary In the experimental group: conformity to TIDieR checklist in each patient TIDieR checklist-patient 2 years
Secondary In the experimental group: conformity to TIDieR checklist in each patient TIDieR checklist-patient 30 Months
Secondary In the experimental group: conformity to TIDieR checklist in each patient TIDieR checklist-patient 3 years
Secondary In the experimental group: conformity to TIDieR checklist in each center Customized TIDieR checklist-center Annually until end of study (5 years)
Secondary Satisfaction of patients and their families Client Satisfaction Questionnaire (CSQ)-8 1 year
Secondary Satisfaction of patients and their families Client Satisfaction Questionnaire (CSQ)-8 2 years
Secondary Satisfaction of patients and their families Client Satisfaction Questionnaire (CSQ)-8 3 years
Secondary Satisfaction of participants receiving help from a health coordinator 7-item custom questionnaire with free answer section End of follow-up (3 years)
See also
  Status Clinical Trial Phase
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Completed NCT03309475 - Effectiveness of a Mindfulness-based Group Training Addressing Social Cognition in First Episode Psychosis (AGES-Mind) N/A
Completed NCT02782442 - Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM) N/A
Recruiting NCT06263933 - Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode N/A
Recruiting NCT05880719 - Pilot and Descriptive Study of the Effects of Setting up Computer-assisted Music (CAM) Remediation Groups on the Cognitive Functioning of Young Patients With a First Episode Psychosis (PEP) N/A
Recruiting NCT06182787 - Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient
Completed NCT04010747 - Pilot Study of Motivational Interviewing for Loved Ones N/A
Recruiting NCT05813457 - Impact of an Early Identification Program for First-Episode Psychosis on the Duration of Untreated Psychosis N/A
Recruiting NCT05167396 - REtinal and VIsual Cortical Response in Early PSYchosis N/A
Completed NCT03434405 - Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study N/A
Active, not recruiting NCT03991377 - A Rater-blinded RCT to Compare Effectiveness of EMDR vs TAU in Patients With First Episode Psychosis and History of Psychological Trauma N/A