Critical Time Intervention-Peer Support

NCT05945277 | Recruiting

• 1 other identifier: CTI-PS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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 pilot randomized controlled trial to evaluate the feasibility, implementation and potential effectiveness 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 effectively implemented in countries with the characteristics of Portugal. Additionally, the proposed research aims to contribute to the global knowledge about peer interventions by exploring whether the CTI model can maintain its effectiveness using peers.

Conditions

Psychotic Disorders; Schizophrenia; Bipolar Disorder; Schizo Affective Disorder

Keywords

Recovery; Peer support; Severe mental illness

Outcome Measures

Primary Outcomes (2)

• 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.

  18 months

• 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.

  18 months

Secondary Outcomes (5)

• Psychopathology, assessed by the Brief Psychiatric Rating Scale (BPRS)

  18 months

• Level of disability, assessed by the WHO Disability Assessment Schedule (WHODAS 2.0)

  18 months

• Orientation toward recovery, assessed by the INSPIRE - Research Into Recovery

  18 months

• Self-stigma, assessed by the Internalized Stigma of Mental Illness (ISMI)

  18 months

• Substance use, assessed by the WHO Alcohol, Smoking and Substance Involvement Screening Test Schedule (WHO ASSIST)

  18 months

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

Behavioral: Critical Time Intervention - Peer Support

Interventions

Critical Time Intervention - Peer Support BEHAVIORAL

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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Active suicidal ideation.
• Cognitive, neurological, or other sensorial conditions likely to preclude or affect an objective assessment via interview procedures

Sponsors & Collaborators

• Lisbon Institute of Global Mental Health - LIGMH: lead
• Columbia University: collaborator

Study Sites (3)

Centro Hospitalar Lisboa Ocidental

Lisbon, Portugal

RECRUITING

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Portugal

RECRUITING

Hospital Beatriz Ângelo

Loures, Portugal

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Bipolar Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Manuela Silva, M.D., PhD

  Lisbon Institute of Global Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Silva, M.D., PhD

CONTACT

+351938711317; manuela.silva@gmail.com

Margarida Dias

CONTACT

+351935900690; info@lisboninstitutegmh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)