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Completed

NCT Number: NCT01995864

Critical Time Intervention-Task Shifting: Randomized Controlled Trial

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorder Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio de Janeiro, Rio de Janeiro, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CTI-TS

Behavioral

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: CTI-TS RCT

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2013
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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