Critical Time Intervention-Task Shifting: Randomized Controlled Trial

Study Overview
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Brief Summary
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The study represents the research component of a broader initiative entitled RedeAmericas. RedeAmericas (RA) is a collaborative effort of investigators from six cities across Latin America (Buenos Aires, Cordoba, Medellin, Neuquen, Rio de Janeiro, and Santiago) and Columbia University in New York. This is a pilot Randomized Controlled Trial (RCT) of Critical Time Intervention-Task Shifting (CTI-TS). It is designed to address a fundamental gap in the services offered by mental health clinics. These clinics are the primary locale for outpatient treatment of individuals with severe mental disorders in the urban areas of Latin America, and they offer some basic and important clinical care such as pharmacologic treatment onsite. Generally these clinics also have a major limitation; they have inadequate resources and training for the provision of in vivo community-based services, that is, services delivered outside of the clinic facility in homes or elsewhere in the community. In most urban areas, they also have weak links to primary health care and are not easily accessible to much of the population. CTI-TS, is a task shifting intervention that at the service user level provides support for better community living and promotes social integration, and at the system level strengthens the connections between mental health and primary care clinics. CTI-TS is a time-limited 9-month intervention provided at the critical time when a person is first offered services at a mental health clinic. During this period CTI-TS workers forge relationships that will shape the continuing use of services and enhance the potential for recovery over the subsequent course of time. The overall goal of CTI-TS is to improve the lives of those with severe mental disorders who receive community-based mental health care.

Detailed Description
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Critical Time Intervention-Task Shifting (CTI-TS)is delivered by lay Community Mental Health Workers (CMHWs) and Peer Support Workers (PSWs) based in mental health outpatient service programs (MHS) and supervised by mental health professionals. These workers provide community outreach and support to engage service users, their families, primary care practitioners, peers and other community members in the recovery process. The CTI-TS program is concerned with improving supports for people recovering from episodes of mental illness. Examples of areas where extra support may be provided include medication management, housing or crisis management, help with the family, help obtaining good services from mental health centers and primary health centers, and help developing social relationships in the community. The program is provided by a CTI-TS team, including a community mental health worker and a peer support worker (someone who has used mental health services in the past, and has recovered). All of the CTI-TS activities will last 9 months. The evaluation of how people fare will last 18 months. The activities of CTI-TS will be in addition to the usual care provided by the subject's local health service. Usual care might include meeting with a mental health professional, meeting with a social worker, and/or obtaining prescriptions for medicine. This study will compare how people fare who have participated in the CTI-TS activities against the group of people who received only the regular services of this community mental health center. As part of the study, a trained researcher will meet with each subject for an interview at the beginning of the project, again 9 months later, and again after 18 months. These interviews will ask questions about how the subject is doing with his/her health and quality of life, and if the subject is getting help or support with problems.

Official Title
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A Pilot Multi-center Randomized Controlled Trial of Critical Time Intervention - Task Shifting (CTI-TS) Versus Usual Care for People With Psychotic Disorders

Conditions
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Schizophrenia, Psychotic Disorder

Intervention / Treatment
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* Behavioral: CTI-TS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21-65 years of age. No longer than 6 months since the first visit to the MHS (excluding visits that took place more than one year ago). Any psychotic disorder (chart diagnosis) from the following groups (ICD-10 criteria): F20-29 including schizophrenia, delusional disorders, schizotypal disorders, acute polymorph psychotic disorders, schizoaffective disorders F30-39 the following mood [affective] disorders with psychoses: F30.2 Mania with psychotic symptoms F31.2 Bipolar affective disorder, current episode manic with psychotic symptoms F31.5 Bipolar affective disorder, current episode severe depression with psychotic symptoms F32.3 Severe depressive episode with psychotic symptoms F33.3 Recurrent depressive disorder, current episode severe with psychotic symptom Exclusion Criteria: Under age 21 or over age 65. Active suicidal ideation. Substance Abuse or Dependence alone (may have psychotic symptoms but does not meet criteria for diagnoses included). Serious cognitive or other sensorial impairment which is likely to preclude reliable assessment via our interview procedures.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTI-TS<br>CTI-TS is a time-limited, 9-month long intervention, provided at the critical time when a person is first offered services at a mental health clinic, or, at the similarly critical time when a person first seeks to reconnect with a mental health clinic after a long lapse. | Behavioral: CTI-TS<br>* The following briefly describes the three phases of CTI-TS: Phase 1: Initiation: The client and CTI-TS team formulate a treatment plan that focuses on selected areas identified as crucial for strengthening stability and facilitating the assimilation of the individual into community living. Phase 2: The Try-Out phase is devoted to testing and adjusting the support systems that have been established in the community. Phase 3: The final phase, Transfer of Care, is devoted to making any necessary improvements in the network of supports of the individual.<br>* Other names: CTI-TS (Critical Time Intervention-Task Shifting);|
| No Intervention: Usual Care<br>The Usual Care group will receive mental health services as provided by the local mental health services clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Camberwell Assessment of Need (CAN) | Used to assess the needs of people with severe mental illness. | 18 months | 
| World Health Organization Quality of Life, Short Form (WHOQOL-BREF) | Used to provide a quality of life measurement. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Disability Assessment Schedule II (WHODAS 2.0) | Measures level of disability | 18 months | 
| Recovery Assessment Scale (RAS) | Assessment tool to measure factors important to recovery | 18 months | 
| Continuity of care and course of illness | CONNECT, a measure of continuity of care, and the Life Chart Schedule are used. | 18 months | 
| Perceived stigma | Perceived Discrimination and Devaluation Scale (PDD) is used for this outcome | 18 months | 
| Self-stigma | Internalized stigma of mental illness (ISMI) is the measure used. | 18 months | 
| Substance use | ASSIST, the WHO Alcohol, Smoking and Substance Involvement Screening Test is used for this measure. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia and Disorders with Psychotic Features, Community Psychiatry