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

June 23, 2020 updated by: Ezra S. Susser, MD, DrPH, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Federal University of Rio de Janeiro
  • Chile
      • Santiago, Chile
        • University of Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Camberwell Assessment of Need (CAN)
Time Frame: 18 months
Used to assess the needs of people with severe mental illness.
18 months
World Health Organization Quality of Life, Short Form (WHOQOL-BREF)
Time Frame: 18 months
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)
Time Frame: 18 months
Measures level of disability
18 months
Recovery Assessment Scale (RAS)
Time Frame: 18 months
Assessment tool to measure factors important to recovery
18 months
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.
18 months
Perceived stigma
Time Frame: 18 months
Perceived Discrimination and Devaluation Scale (PDD) is used for this outcome
18 months
Self-stigma
Time Frame: 18 months
Internalized stigma of mental illness (ISMI) is the measure used.
18 months
Substance use
Time Frame: 18 months
ASSIST, the WHO Alcohol, Smoking and Substance Involvement Screening Test is used for this measure.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Ezra Susser, MD, DrPH, Columbia University
  • Principal Investigator: Graciela Rojas, MD, University of Chile
  • Principal Investigator: Sandro Galea, MD DrPH, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAI1845
  • U19MH095718 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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