Critical Time Intervention-Peer Support (CTI-PS)
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| ClinicalTrials.gov Identifier: NCT05945277 |
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Recruitment Status :
Recruiting
First Posted : July 14, 2023
Last Update Posted : December 13, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psychotic Disorders Schizophrenia Bipolar Disorder Schizo Affective Disorder | Behavioral: Critical Time Intervention - Peer Support | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 168 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 1, 2023 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Control | |
| 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. |
- 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.
- 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.
- Psychopathology, assessed by the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 18 months ]
- Level of disability, assessed by the WHO Disability Assessment Schedule (WHODAS 2.0) [ Time Frame: 18 months ]
- Orientation toward recovery, assessed by the INSPIRE - Research Into Recovery [ Time Frame: 18 months ]
- Self-stigma, assessed by the Internalized Stigma of Mental Illness (ISMI) [ Time Frame: 18 months ]
- Substance use, assessed by the WHO Alcohol, Smoking and Substance Involvement Screening Test Schedule (WHO ASSIST) [ Time Frame: 18 months ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945277
| Contact: Manuela Silva, M.D., PhD | +351938711317 | manuela.silva@gmail.com | |
| Contact: Margarida Dias | +351935900690 | info@lisboninstitutegmh.org |
| Portugal | |
| Centro Hospitalar Lisboa Ocidental | Recruiting |
| Lisbon, Portugal | |
| Contact: Joaquim Gago joaquimgago@me.com | |
| Centro Hospitalar Universitário Lisboa Norte | Recruiting |
| Lisbon, Portugal | |
| Contact: Manuela Silva, M.D., PhD +351938711317 manuela.silva@gmail.com | |
| Hospital Beatriz Ângelo | Recruiting |
| Loures, Portugal | |
| Contact: Maria João Heitor, M.D., PhD maria.heitor@hbeatrizangelo.pt | |
| Principal Investigator: | Manuela Silva, M.D., PhD | Lisbon Institute of Global Mental Health |
| Responsible Party: | Lisbon Institute of Global Mental Health - LIGMH |
| ClinicalTrials.gov Identifier: | NCT05945277 |
| Other Study ID Numbers: |
CTI-PS |
| First Posted: | July 14, 2023 Key Record Dates |
| Last Update Posted: | December 13, 2023 |
| Last Verified: | December 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Recovery Peer support Severe mental illness |
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Schizophrenia Bipolar Disorder Psychotic Disorders Mood Disorders |
Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders |