Psychotic DisordersCTI-PSNCT05945277
Critical Time Intervention-Peer Support
A study testing Critical Time Intervention - Peer Support in people with Psychotic Disorders and Schizophrenia, run by Lisbon Institute of Global Mental Health - LIGMH at 3 sites in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
- What is being tested?
- Critical Time Intervention - Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesPortugal
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active suicidal ideation.
- Cognitive, neurological, or other sensorial conditions likely to preclude or affect an objective assessment via interview procedures
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites, 3 recruiting
- Recruiting
Centro Hospitalar Lisboa Ocidental
Lisbon
Joaquim Gago, joaquimgago@me.com
- Recruiting
Centro Hospitalar Universitário Lisboa Norte
Lisbon
Manuela Silva, M.D., PhD, +351938711317, manuela.silva@gmail.com
- Recruiting
Hospital Beatriz Ângelo
Loures
Maria João Heitor, M.D., PhD, maria.heitor@hbeatrizangelo.pt
About this study
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
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.
Read the 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.
- Being tested
- Critical Time Intervention - Peer Support
- Keywords
- Recovery, Peer support, Severe mental illness
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Time Intervention - Peer SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Critical Time Intervention - Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (5)
Psychopathology, assessed by the Brief Psychiatric Rating Scale (BPRS)
Measured: 18 months
Level of disability, assessed by the WHO Disability Assessment Schedule (WHODAS 2.0)
Measured: 18 months
Orientation toward recovery, assessed by the INSPIRE - Research Into Recovery
Measured: 18 months
Self-stigma, assessed by the Internalized Stigma of Mental Illness (ISMI)
Measured: 18 months
Substance use, assessed by the WHO Alcohol, Smoking and Substance Involvement Screening Test Schedule (WHO ASSIST)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisbon Institute of Global Mental Health - LIGMH
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Manuela Silva, M.D., PhD, Principal investigator, Lisbon Institute of Global Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945277
- Sponsor's protocol ID
- CTI-PS
- Acronym
- CTI-PS
- Status last verified
- Jun 2024
- First submitted
- 6 Jul 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05945277
- Acronym / sponsor ID
- CTI-PS / CTI-PS
- Keywords
- Recovery, Peer support, Severe mental illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lisbon Institute of Global Mental Health - LIGMHUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: Critical Time Intervention - Peer Support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Active suicidal ideation.
- Cognitive, neurological, or other sensorial conditions likely to preclude or affect an objective assessment via interview procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical Time Intervention - Peer SupportCTI-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. | Behavioural | Intervention |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuela Silva, M.D., PhD principal investigator
Lisbon Institute of Global Mental Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical Time Intervention - Peer Support in people with Psychotic Disorders and Schizophrenia, run by Lisbon Institute of Global Mental Health - LIGMH at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuela Silva, M.D., PhD (+351938711317, manuela.silva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHOQOL-BREF (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.