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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Keele University
Funder	National Institute for Health and Care Research

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Saeed Farooq
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
Email	s.farooq@keele.ac.uk

Dr Nalinda Wellappuli
Scientific

School of Medicine, University of Keele, Keele
Newcastle under Lyme
ST5 5GB
United Kingdom

ORCID ID	0000-0001-6934-2226
Phone	+44 7405862955
Email	n.wellappuli@keele.ac.uk

Dr Nishani Fonseka
Public

School of Medicine, University of Keele, Keele
Newcastle under Lyme
ST5 5GB
United Kingdom

ORCID ID	0000-0001-5955-2211
Phone	+44 7902549258
Email	h.n.afonseka@keele.ac.uk

Study information

Primary study design	Observational
Study design	Observational cross sectional cohort study
Secondary study design	Cross sectional study
Study type	Participant information 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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/02/2029

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	35 Years
Sex	All
Target sample size at registration	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

Deaprtment of Psychiatry, Ayub Medical Teaching Institution

Main Mansehra Road
Abbottabad
Kyber Pakhtunkhwa Province
Pakistan

Deapartment of Psychiatry and Behavioural Sciences

Faisalabad Medical University, Allied/ District Head Quarters Hospital -Faisalabad, Mall Road
Faisalabad
38000
Pakistan

Department of Psychiatry, Liaquat University of Medical and Health Sciences, Jamshoro, Hyderabad

Administration Block, Deh Soun Valhar
Jamshoro, Hyderbad
76090
Pakistan

Department of Psychiatry, Balochistan Institute of Psychiatry and Behavioural Sciences (BIPBS) , Quetta

Balochistan Institute of Psychiatry and Behavioral Sciences (BIPBS), Behind BMC Hospital, Berwery Road
Quetta
00
Pakistan

Department of Psychiatry, Medical Teaching Institute, Lady Reading Hospital, Peshawar

Soekarno Rd, Pipal Mandi
Peshawar
25000
Pakistan

Institute of Public Mental Health and Behavioural Sciences, Khyber Medical University, Peshawar

KMU Main Campus, Phase 5, Hayatabad
Peshawar
Kyber Pakhtunkhwa Province
Pakistan

National Hospital Galle

Karapitiya
Galle
00
Sri Lanka

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

u09/09/2025: Trial's existence confirmed by DHSC.