Critical Time Intervention-Task Shifting: Randomized Controlled Trial

NCT01995864 | Completed DMC

• 2 other identifiers: AAAI1845U19MH095718
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 2

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.

Conditions

Schizophrenia; Psychotic Disorder

Keywords

Schizophrenia and Disorders with Psychotic Features; Community Psychiatry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• World Health Organization Disability Assessment Schedule II (WHODAS 2.0)

  18 months

• Recovery Assessment Scale (RAS)

  18 months

• Continuity of care and course of illness

  18 months

• Perceived stigma

  18 months

• Self-stigma

  18 months

Study Arms (2)

CTI-TS

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

The Usual Care group will receive mental health services as provided by the local mental health services clinic.

Interventions

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.

Also known as: CTI-TS (Critical Time Intervention-Task Shifting)

CTI-TS

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Federal University of Rio de Janeiro

Rio de Janeiro, Brazil

Location

University of Chile

Santiago, Chile

Location

Related Publications (12)

• 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.

  PMID: 23990755 BACKGROUND

• 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.

  PMID: 22794167 BACKGROUND

• 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.

  PMID: 25339792 BACKGROUND

• Herman D, Opler L, Felix A, Valencia E, Wyatt RJ, Susser E. A critical time intervention with mentally ill homeless men: impact on psychiatric symptoms. J Nerv Ment Dis. 2000 Mar;188(3):135-40. doi: 10.1097/00005053-200003000-00002.

  PMID: 10749277 BACKGROUND

• Jones K, Colson PW, Holter MC, Lin S, Valencia E, Susser E, Wyatt RJ. Cost-effectiveness of critical time intervention to reduce homelessness among persons with mental illness. Psychiatr Serv. 2003 Jun;54(6):884-90. doi: 10.1176/appi.ps.54.6.884.

  PMID: 12773605 BACKGROUND

• Herman DB, Conover S, Gorroochurn P, Hinterland K, Hoepner L, Susser ES. Randomized trial of critical time intervention to prevent homelessness after hospital discharge. Psychiatr Serv. 2011 Jul;62(7):713-9. doi: 10.1176/ps.62.7.pss6207_0713.

  PMID: 21724782 BACKGROUND

• Susser E, Valencia E, Conover S, Felix A, Tsai WY, Wyatt RJ. Preventing recurrent homelessness among mentally ill men: a "critical time" intervention after discharge from a shelter. Am J Public Health. 1997 Feb;87(2):256-62. doi: 10.2105/ajph.87.2.256.

  PMID: 9103106 BACKGROUND

• 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.

  PMID: 30791796 BACKGROUND

• Baumgartner JN, da Silva TF, Valencia E, Susser E. Measuring social integration in a pilot randomized controlled trial of critical time: intervention-task shifting in Latin America. Cad Saude Colet. 2012 Jan;20(4):10.1590/S1414-462X2012000400005. doi: 10.1590/S1414-462X2012000400005.

  PMID: 24288454 BACKGROUND

• 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.

  PMID: 28596904 BACKGROUND

• Mascayano F, Alvarado R, Andrews HF, Jorquera MJ, Lovisi GM, Souza FM, Pratt C, Rojas G, Restrepo-Toro ME, Fader K, Gorroochurn P, Galea S, Dahl CM, Cintra J, Conover S, Burrone MS, Baumgartner JN, Rosenheck R, Schilling S, Sarucao KR, Stastny P, Tapia E, Cavalcanti MT, Valencia E, Yang LH, Susser E. Implementing the protocol of a pilot randomized controlled trial for the recovery-oriented intervention to people with psychoses in two Latin American cities. Cad Saude Publica. 2019 May 2;35(4):e00108018. doi: 10.1590/0102-311X00108018.

  PMID: 31066775 BACKGROUND

• Mascayano F, Alvarado R, Andrews HF, Baumgartner JN, Burrone MS, Cintra J, Conover S, Dahl CM, Fader KM, Gorroochurn P, Galea S, Jorquera MJ, Lovisi GM, Mitkiewicz de Souza F, Pratt C, Restrepo-Toro ME, Rojas G, Rodrigues Sarucao K, Rosenheck R, Schilling S, Shriver T, Stastny P, Tapia E, Cavalcanti MT, Valencia E, Yang LH, Restrepo Henao A, Martinez-Ales G, Romero Pardo V, Gomez Alemany T, Susser E. A Recovery-Oriented Intervention for People With Psychosis: A Pilot Randomized Controlled Trial. Psychiatr Serv. 2022 Nov 1;73(11):1225-1231. doi: 10.1176/appi.ps.202000843. Epub 2022 Jun 9.

  PMID: 35678081 DERIVED

Related Links

• RedeAmericas is a National Institute of Mental Health (NIMH)-funded regional network or 'hub' for public mental health research in Latin America.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Psychiatry

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 27, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); CL (1)