Critical Time Intervention-Task Shifting: Randomized Controlled Trial

Schizophrenia Clinical Trial

— CTI-TS RCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995864
• Other study ID #: AAAI1845
• Secondary ID: U19MH095718
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro
Chile	University of Chile	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Brazil,  Chile, 

References & Publications (11)

Agrest M, Le PD, Yang LH, Mascayano F, Alves-Nishioka S, Dev S, Kankan T, Tapia-Muñoz 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. — View Citation

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). doi: 10.1590/S1414-462X2012000400005. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Sarução 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. — View Citation

Minoletti A, Galea S, Susser E. Community mental health services in Latin America. Public Health Reviews, 34(2):1-23, 2013.

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. — View Citation

Yang L, Pratt C, Valencia E, Conover S, Fernández 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Camberwell Assessment of Need (CAN)	Used to assess the needs of people with severe mental illness.	18 months
Primary	World Health Organization Quality of Life, Short Form (WHOQOL-BREF)	Used to provide a quality of life measurement.	18 months
Secondary	World Health Organization Disability Assessment Schedule II (WHODAS 2.0)	Measures level of disability	18 months
Secondary	Recovery Assessment Scale (RAS)	Assessment tool to measure factors important to recovery	18 months
Secondary	Continuity of care and course of illness	CONNECT, a measure of continuity of care, and the Life Chart Schedule are used.	18 months
Secondary	Perceived stigma	Perceived Discrimination and Devaluation Scale (PDD) is used for this outcome	18 months
Secondary	Self-stigma	Internalized stigma of mental illness (ISMI) is the measure used.	18 months
Secondary	Substance use	ASSIST, the WHO Alcohol, Smoking and Substance Involvement Screening Test is used for this measure.	18 months

External Links

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