Critical Time Intervention-Peer Support (CTI-PS)

December 12, 2023 updated by: Lisbon Institute of Global Mental Health - LIGMH

Effectiveness of the Critical Time Intervention-Peer Support (CTI-PS) Model for Persons With Serious Mental Illness Discharged From Inpatient Psychiatric Treatment Facilities in Portugal

There is increasing awareness of the importance of providing mental health services and support that promote a recovery-oriented and human rights-based approach. A mental health service system that is guided by a rehabilitation and recovery perspective places emphasis on treating the consequences of the illness rather than just the illness "per se", and on empowering people to regain control of their identity and life, and to have hope for the future. Within this philosophy, mental health policies in several countries advocate for the introduction of peer workers in mental health services, people with lived experience of mental health issues and recovery, who are employed to use their lived experience to support those who access mental health services. However, more effectiveness and implementation research is needed. Evidence also suggests that the period following hospital discharge is of high risk of treatment dropout for people with serious mental illness, thus interrupting their recovery process. Therefore, this vulnerable population may particularly benefit from more targeted interventions during this transitional period.

The research project will conduct a randomized controlled trial to evaluate the effectiveness, feasibility and implementation of the Critical Time Intervention-Peer Support model, a recovery-oriented based model for people with serious mental illness discharged from inpatient psychiatric treatment facilities in Portugal. The randomized controlled trial (RCT) will be conducted in three psychiatric services in the Lisbon Metropolitan Area and their catchment areas. People with diagnoses of psychotic disorders discharged from inpatient psychiatric treatment facilities will be recruited and randomly divided into CTI-PS intervention or usual care. Those allocated to the intervention group will additionally receive CTI-PS rather than usual care alone over a 9-month period. Outcomes at baseline, 9- and 18-months will be analyzed by multilevel models, considering the observations clustered within sites. Longitudinal analyses will be used to examine trends over time of the outcomes of interest.

The implementation of the CTI-PS model will introduce a novel approach to community mental health care that has not yet been tried in Portugal. This study aims to explore to what extent this intervention can be effective and implemented in countries with the characteristics of Portugal. Additionally, the proposed research aims to contribute to the global knowledge about peer interventions by investigating whether the CTI model maintains its effectiveness using peers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Critical Time Intervention-Peer Support is delivered by Community Mental Health Workers (CMHWs) and Peer Support Workers (PSWs). They will be selected, recruited, and trained by members of the research team to deliver mental health care according to the manualized recovery-oriented program. Ongoing regular supervision of PSWs and CMHWs, in weekly meetings, will be conducted throughout the study by members of the research team trained in CTI-PS by those who originally developed it at the Columbia University.

Those allocated to the intervention group will receive usual care and, in addition, CTI-PS services over a 9-month period.

The intervention has two broad objectives: 1) to collaborate with participants to develop durable connections to support systems, including both formal and informal supports (e.g., mental health services, primary care clinics, family, and friends); and 2) to provide practical and emotional support, helping the individual to overcome a critical period of transition during which they can feel especially vulnerable.

The work of CTI-PS will focus on areas identified as crucial for strengthening the individual's continuum of services and forming enduring links with their community supports. The phases of CTI are Initiation, Try-Out, and Transfer of Care. The PSW-CMHW will collaborate with the participants to identify barriers to their recovery and develop a sustainable plan to engage in and use community supports and resources during and after CTI. They will also use their knowledge to increase participants' autonomy, strengthen their connection to health services, and expand their support networks. The role of CTI workers is specifically designed to avoid becoming the primary source of care for the individual.

Study Type

Interventional

Enrollment (Estimated)

168

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 Contact

Study Contact Backup

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Centro Hospitalar Universitário Lisboa Norte
        • Contact:
      • Lisbon, Portugal
        • Recruiting
        • Centro Hospitalar Lisboa Ocidental
        • Contact:
      • Loures, Portugal

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 years of age.
  • Any psychotic disorder diagnosis based on the International Classification of Diseases - 10th revision (ICD-10) criteria, including both non-affective (e.g., schizophrenia) and affective psychosis (e.g., bipolar disorder)
  • Having been discharged from inpatient psychiatric treatment facilities in the month prior to recruitment

Exclusion Criteria:

  • Active suicidal ideation.
  • Cognitive, neurological, or other sensorial conditions likely to preclude or affect an objective assessment via 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Critical Time Intervention - Peer Support
CTI-PS is a time-limited, 9-month long intervention, provided at the critical time when a person is discharged from an inpatient psychiatric treatment facility.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHOQOL-BREF
Time Frame: 18 months
Health-related quality of life, assessed by the WHO Quality of Life Scale - Brief Version (WHOQOL-BREF). This instrument has 26 items and measures the following domains: physical and psychological health, social relationships, and environment, with two additional general questions.
18 months
Camberwell Assessment of Need (CAN)
Time Frame: 18 months
Unmet needs, assessed by the Camberwell Assessment of Need (CAN), which evaluates 22 areas of need such as accommodation, food, safety to self, among others.
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychopathology, assessed by the Brief Psychiatric Rating Scale (BPRS)
Time Frame: 18 months
18 months
Level of disability, assessed by the WHO Disability Assessment Schedule (WHODAS 2.0)
Time Frame: 18 months
18 months
Orientation toward recovery, assessed by the INSPIRE - Research Into Recovery
Time Frame: 18 months
18 months
Self-stigma, assessed by the Internalized Stigma of Mental Illness (ISMI)
Time Frame: 18 months
18 months
Substance use, assessed by the WHO Alcohol, Smoking and Substance Involvement Screening Test Schedule (WHO ASSIST)
Time Frame: 18 months
18 months

Collaborators and Investigators

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

Sponsor

Lisbon Institute of Global Mental Health - LIGMH

Collaborators

Columbia University

Investigators

  • Principal Investigator: Manuela Silva, M.D., PhD, Lisbon Institute of Global Mental Health

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.

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)

July 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI-PS

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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