Translating evidence for early intervention in psychosis (TRANSLATE) in low and lower-middle countries (LMIC): implementation and evaluation
| ISRCTN | ISRCTN16495294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16495294 |
- Submission date
- 09/09/2025
- Registration date
- 22/10/2025
- Last edited
- 22/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study is about helping young people in Pakistan and Sri Lanka who are experiencing psychosis for the first time. Psychosis is a mental health condition that affects how people think, feel, and behave. In many low- and middle-income countries, people often wait a long time before getting treatment—sometimes over two years. This delay can seriously affect their quality of life, education, and ability to work.
In countries like the UK, early intervention services help people get treatment quickly, which leads to better outcomes. This study aims to set up similar early intervention services in Pakistan and Sri Lanka. It also wants to understand why some people don’t respond well to treatment (a condition called treatment resistant schizophrenia) and whether we can predict who might be at risk.
Who can participate?
People in Pakistan and Sri Lanka who are experiencing psychosis for the first time may be invited to take part in the study. The research team will work with local mental health services to identify potential participants.
What does the study involve?
Participants will receive care through the new early intervention services. The team will collect information about their health, treatment, and progress over time. Some participants may also be asked to provide additional information to help researchers understand why some people don’t respond to treatment.
What are the possible benefits and risks of participating?
The main benefit is receiving care earlier than usual, which can lead to better recovery and improved quality of life. There may be some risks, such as feeling uncomfortable when answering personal questions or sharing health information, but the research team will take steps to protect participants' privacy and wellbeing.
Where is the study run from?
Keele University (UK)
When is the study starting and how long is it expected to run for?
April 2024 to February 2029
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
s.farooq@keele.ac.uk
n.wellappuli@keele.ac.uk
h.n.a.fonseka@keele.ac.uk
Contact information
Principal Investigator
School of Medicine, University of Keele, Keele
Newcastle under Lyme
ST5 5GB
United Kingdom
 ORCID ID |
0000-0002-6910-3003 |
|---|---|
| Phone | +44 7958012102 |
| s.farooq@keele.ac.uk |
Scientific
School of Medicine, University of Keele, Keele
Newcastle under Lyme
ST5 5GB
United Kingdom
| ORCID ID |
0000-0001-6934-2226 |
|---|---|
| Phone | +44 7405862955 |
| n.wellappuli@keele.ac.uk |
Public
School of Medicine, University of Keele, Keele
Newcastle under Lyme
ST5 5GB
United Kingdom
| ORCID ID |
0000-0001-5955-2211 |
|---|---|
| Phone | +44 7902549258 |
| h.n.afonseka@keele.ac.uk |
Study information
| Study design | Observational cross sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant informaiton sheet. |
| Scientific title | Translating evidence for Early Intervention in Psychosis (TRANSLATE) in Low and Lower-Middle Countries (LMIC): Implementation and Evaluation |
| Study acronym | TRANSLATE |
| Study objectives | 1. To evaluate the implementation of Early Intervention in Psychosis (EIP) services in maintaining engagement with the services, achieving remission in First Episode of Psychosis, and other relevant implementation outcomes. 2. To assemble a cohort of FEP within the EIP service and identify potential predicting factors of Treatment Resistant Schizophrenia at one-year follow-up. 3. To develop a prognostic model for estimating an individual's risk of treatment resistance at one year and to undertake the validation of the model's predictive performance. |
| Ethics approval(s) |
1. Approved 11/06/2025, Keele University’s Research Ethics Committee (Keele University, Keele, Newcastle Under Lyme, ST5 5GB, United Kingdom; +44 1782 733937; health.ethics@keele.ac.uk), ref: 1028 2. Approved 28/03/2025, Kyber Medical University - Institute of Public Health and Social Sciences (KMU, Phase-5, Hayatabad, -, Pakistan; +91-5892867; drshaista.iph@kmu.edu.pk), ref: KMU/IPHSS/Ethics/2025/TE/260 |
| Health condition(s) or problem(s) studied | First episode psychosis and treatment resistant schizophrenia |
| Intervention | Patients with a diagnosis of First episode Psychosis (FEP) will be recruited. The participants will be assessed at the baseline and follow up in 1, 3,6, and 12-month period with pre identified tools. All participants will receive care following the clinical guidelines developed for the management of FEP in the study settings. The package of care will include evidence-based pharmacotherapy, cognitive behaviour therapy and other psychosocial interventions. The treatment will be provided by trained psychiatrists and psychologists. The supervising psychiatrist will decide the choice of medication, dosage and other interventions after involving patients and families in the treatment according to the clinical practice guidelines adopted for management of First Episode Psychosis in Pakistan and Sri Lanka. Each participant will be allocated a care coordinator to coordinate the services to ensure the receipt of services that prescribed to given for each patient. The patients will be followed up for one year to estimate the rates of remission, engagement with the service and other clinical outcomes during the study. The duration of observation and total duration of follow-up will be 12 months for each participant. This study is not aimed at testing the efficacy related to the individual drugs or other interventions, these are well established. Our aim is to assess the implantation effectiveness of the Early Intervention in Psychosis services in resource poor settings. |
| Intervention type | Other |
| Primary outcome measure | 1. Disengagement from service is measured using clinic records and care coordinator notes at 1, 3, 6, and 12 months 2. Remission is measured using PANSS (score ≤3) or YMRS (score ≤12) at 1, 3, 6, and 12 months |
| Secondary outcome measures | 1. Change in occupational and social functioning is measured using WHODAS 2.0 at 1, 3, 6, and 12 months 2. Psychopathology symptom severity is measured using PANSS, YMRS, and HDRS at 1, 3, 6, and 12 months 3. Family burden is measured using the Family Burden Scale at 3 and 12 months 4. Perceived stigma is measured using the Modified Internalized Stigma of Mental Illness tool (ISMI) at 12 months 5. Blood pressure is measured using clinic records at 1, 3, 6, and 12 months 6. BMI is measured using clinic records at 1, 3, 6, and 12 months 7. Cardiovascular disease risk is measured using WHO-STEPS at 12 months 8. Appropriateness is measured using the Intervention Appropriateness Measure tool (IAM) at 12 months 9. Feasibility is measured using the Feasibility Intervention Measure at 12 months 10. Acceptability is measured using the Applied Mental Health Research Group tool at 12 months 11. Fidelity of CBT delivery is measured using the Revised Cognitive Therapy Scale (CTS-R) at 12 months 12. Implementation cost is measured using administrative data logs collected over the one-year period |
| Overall study start date | 01/04/2024 |
| Completion date | 01/02/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 670 |
| Key inclusion criteria | 1. Patients aged 18-35 years and 2. Residing within the study districts 3. Diagnosed with First-ever psychotic episode who have not received antipsychotic medication previously, or if they already have used antipsychotic medications, it was for no longer than six weeks |
| Key exclusion criteria | 1. Those with an overt learning disability 2. Those with severe substance abuse (except nicotine dependence) 3. Those with organic illness associated with psychotic symptoms |
| Date of first enrolment | 01/09/2025 |
| Date of final enrolment | 31/01/2029 |
Locations
Countries of recruitment
- Pakistan
- Sri Lanka
Study participating centres
Abbottabad
Kyber Pakhtunkhwa Province
Pakistan
Faisalabad
38000
Pakistan
Jamshoro, Hyderbad
76090
Pakistan
Quetta
00
Pakistan
Peshawar
25000
Pakistan
Peshawar
Kyber Pakhtunkhwa Province
Pakistan
Galle
00
Sri Lanka
Sponsor information
University/education
Keele
Newcastle-under-Lyme
ST5 5GB
England
United Kingdom
| Phone | +44 1782 732000 |
|---|---|
| enquiries@keele.ac.uk | |
| Website | https://www.keele.ac.uk |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We have planned to publish following research articles in peer reviewed journals; 1. Manuscript on TRANSLATE research protocol 2. Manuscript in barriers and facilitators for implementation of the Early Intervention in Psychosis (EIP) service model in the LMIC context 3. Manuscript on development of a prognostic model to predict treatment-resistant schizophrenia 4. Manuscript implementation effectiveness of the EIP model in Pakistan and Sri Lanka In addition to the research articles, we will be conducting research dissemination workshops in UK, Pakistan and Sri Lanka. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Professor Saeed Farooq - s.farooq@keele.ac.uk |
Editorial Notes
u09/09/2025: Trial's existence confirmed by DHSC.
