search
Back to results

Critical Time Intervention-Peer Support (CTI-PS)

Primary Purpose

Psychotic Disorders, Schizophrenia, Bipolar Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Critical Time Intervention - Peer Support
Sponsored by
Lisbon Institute of Global Mental Health - LIGMH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Recovery, Peer support, Severe mental illness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Hospitalar Lisboa Ocidental
  • Centro Hospitalar Universitário Lisboa Norte
  • Hospital Beatriz Ângelo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Outcomes

Primary Outcome Measures

WHOQOL-BREF
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.
Camberwell Assessment of Need (CAN)
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2023
Last Updated
July 6, 2023
Sponsor
Lisbon Institute of Global Mental Health - LIGMH
Collaborators
Columbia University
search

1. Study Identification

Unique Protocol Identification Number
NCT05945277
Brief Title
Critical Time Intervention-Peer Support
Acronym
CTI-PS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisbon Institute of Global Mental Health - LIGMH
Collaborators
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia, Bipolar Disorder, Schizo Affective Disorder
Keywords
Recovery, Peer support, Severe mental illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Critical Time Intervention - Peer Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
WHOQOL-BREF
Description
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.
Time Frame
18 months
Title
Camberwell Assessment of Need (CAN)
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Psychopathology, assessed by the Brief Psychiatric Rating Scale (BPRS)
Time Frame
18 months
Title
Level of disability, assessed by the WHO Disability Assessment Schedule (WHODAS 2.0)
Time Frame
18 months
Title
Orientation toward recovery, assessed by the INSPIRE - Research Into Recovery
Time Frame
18 months
Title
Self-stigma, assessed by the Internalized Stigma of Mental Illness (ISMI)
Time Frame
18 months
Title
Substance use, assessed by the WHO Alcohol, Smoking and Substance Involvement Screening Test Schedule (WHO ASSIST)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Silva, M.D., PhD
Phone
+351938711317
Email
manuela.silva@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Margarida Dias
Phone
+351935900690
Email
info@lisboninstitutegmh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuela Silva, M.D., PhD
Organizational Affiliation
Lisbon Institute of Global Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar Lisboa Ocidental
City
Lisbon
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquim Gago
Email
joaquimgago@me.com
Facility Name
Centro Hospitalar Universitário Lisboa Norte
City
Lisbon
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Silva, M.D., PhD
Phone
+351938711317
Email
manuela.silva@gmail.com
Facility Name
Hospital Beatriz Ângelo
City
Loures
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria João Heitor, M.D., PhD
Email
maria.heitor@hbeatrizangelo.pt

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.criticaltime.org/cti-model/
Description
Related Info
URL
http://lisboninstitutegmh.org
Description
Related Info

Learn more about this trial

Critical Time Intervention-Peer Support

We'll reach out to this number within 24 hrs