Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05945277 |
| Other study ID # |
CTI-PS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
Lisbon Institute of Global Mental Health - LIGMH |
| Contact |
Manuela Silva, M.D., PhD |
| Phone |
+351938711317 |
| Email |
manuela.silva[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
