Clinical trial NCT01995864: Critical Time Intervention-Task Shifting: Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychotic Disorder
Keywords: Schizophrenia and Disorders with Psychotic Features
Community Psychiatry
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-11-27
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Camberwell Assessment of Need (CAN)
timeFrame: 18 months
measure: World Health Organization Quality of Life, Short Form (WHOQOL-BREF)
timeFrame: 18 months
Secondary outcomes:
measure: World Health Organization Disability Assessment Schedule II (WHODAS 2.0)
timeFrame: 18 months
measure: Recovery Assessment Scale (RAS)
timeFrame: 18 months
measure: Continuity of care and course of illness
timeFrame: 18 months
measure: Perceived stigma
timeFrame: 18 months
measure: Self-stigma
timeFrame: 18 months
measure: Substance use
timeFrame: 18 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
city: Santiago
country: Chile
facility: University of Chile
Study officials:
affiliation: Columbia University
name: Ezra Susser, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Graciela Rojas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Sandro Galea, MD DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Ruben Alvarado, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang LH, Valencia E, Alvarado R, Link B, Huynh N, Nguyen K, Morita K, Saavedra M, Wong C, Galea S, Susser E. A theoretical and empirical framework for constructing culture-specific stigma instruments for Chile. Cad Saude Colet. 2013;21(1):71-79. doi: 10.1590/s1414-462x2013000100011.
citation: Baumgartner JN, Susser E. Social integration in global mental health: what is it and how can it be measured? Epidemiol Psychiatr Sci. 2013 Mar;22(1):29-37. doi: 10.1017/S2045796012000303. Epub 2012 May 25.
citation: Minoletti A, Galea S, Susser E. Community Mental Health Services in Latin America for People with Severe Mental Disorders. Public Health Rev. 2012;34(2):http://www.publichealthreviews.eu/show/a/116. doi: 10.1007/BF03391681.
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citation: Agrest M, Le PD, Yang LH, Mascayano F, Alves-Nishioka S, Dev S, Kankan T, Tapia-Munoz T, Sawyer S, Toso-Salman J, Dishy GA, Jorquera MJ, Schilling S, Pratt C, Price L, Valencia E, Conover S, Alvarado R, Susser ES. Implementing a community-based task-shifting psychosocial intervention for individuals with psychosis in Chile: Perspectives from users. Int J Soc Psychiatry. 2019 Feb;65(1):38-45. doi: 10.1177/0020764018815204.
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citation: Yang L, Pratt C, Valencia E, Conover S, Fernandez R, Burrone MS, Cavalcanti MT, Lovisi G, Rojas G, Alvarado R, Galea S, Price LN, Susser E. RedeAmericas: building research capacity in young leaders for sustainable growth in community mental health services in Latin America. Glob Ment Health (Camb). 2017 Feb 14;4:e3. doi: 10.1017/gmh.2017.2. eCollection 2017.
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