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Critical Time Intervention-Task Shifting: Randomized Controlled Trial (CTI-TS RCT)

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ClinicalTrials.gov Identifier: NCT01995864
Recruitment Status : Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Ezra S. Susser, MD, DrPH, Columbia University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorder Behavioral: CTI-TS Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Pilot Multi-center Randomized Controlled Trial of Critical Time Intervention - Task Shifting (CTI-TS) Versus Usual Care for People With Psychotic Disorders
Actual Study Start Date : February 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CTI-TS
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

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.

Other Name: CTI-TS (Critical Time Intervention-Task Shifting)

No Intervention: Usual Care
The Usual Care group will receive mental health services as provided by the local mental health services clinic.



Primary Outcome Measures :
  1. Camberwell Assessment of Need (CAN) [ Time Frame: 18 months ]
    Used to assess the needs of people with severe mental illness.

  2. World Health Organization Quality of Life, Short Form (WHOQOL-BREF) [ Time Frame: 18 months ]
    Used to provide a quality of life measurement.


Secondary Outcome Measures :
  1. World Health Organization Disability Assessment Schedule II (WHODAS 2.0) [ Time Frame: 18 months ]
    Measures level of disability

  2. Recovery Assessment Scale (RAS) [ Time Frame: 18 months ]
    Assessment tool to measure factors important to recovery

  3. Continuity of care and course of illness [ Time Frame: 18 months ]
    CONNECT, a measure of continuity of care, and the Life Chart Schedule are used.

  4. Perceived stigma [ Time Frame: 18 months ]
    Perceived Discrimination and Devaluation Scale (PDD) is used for this outcome

  5. Self-stigma [ Time Frame: 18 months ]
    Internalized stigma of mental illness (ISMI) is the measure used.

  6. Substance use [ Time Frame: 18 months ]
    ASSIST, the WHO Alcohol, Smoking and Substance Involvement Screening Test is used for this measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995864


Locations
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Brazil
Federal University of Rio de Janeiro
Rio de Janeiro, Brazil
Chile
University of Chile
Santiago, Chile
Sponsors and Collaborators
Columbia University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Ezra Susser, MD, DrPH Columbia University
Principal Investigator: Graciela Rojas, MD University of Chile
Principal Investigator: Sandro Galea, MD DrPH Boston University
Principal Investigator: Ruben Alvarado, MD PhD University of Chile

Additional Information:
Publications:

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Responsible Party: Ezra S. Susser, MD, DrPH, Professor of Epidemiology and Psychiatry, Columbia University
ClinicalTrials.gov Identifier: NCT01995864     History of Changes
Other Study ID Numbers: AAAI1845
U19MH095718 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Keywords provided by Ezra S. Susser, MD, DrPH, Columbia University:
Schizophrenia and Disorders with Psychotic Features
Community Psychiatry
Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders