Individuals at Risk of First Episode PsychosisNCT07188597
Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis
A study testing Cognitive Behavior Therapy for those at risk of first episode psychosis in people with Individuals at Risk of First Episode Psychosis, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
Trial summary
Young people constitute nearly half of Pakistan's population and are highly vulnerable to risk factors for mental illness, including poverty, inequality, abuse, and violence. Estimates suggest that 19-34% of children and adolescents experience emotional or behavioural disorders, though this is likely underestimated. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Individuals at Risk of First Episode Psychosis
- What is being tested?
- Cognitive Behavior Therapy for those at risk of first episode psychosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female help-seeking individual aged 16-35 years;
- Score 6 or above on PQ-16
- Meet the at risk of FEP criteria using CAARMS Operationalized Intake Criteria based on three groups (vulnerability, attenuated psychosis or brief limited intermittent psychotic symptoms group);
- Assessed as competent to provide informed consent.
- Give written informed consent.
Who cannot join
- Temporary resident unlikely to be available for follow up.
- Unable to engage, participate or respond to research questionnaires.
- a history of psychotic illness (treated or untreated).
- previous treatment with an antipsychotic or mood-stabilising agent.
- active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Commuity/Schools/Colleges
Karachi, Sindh
- Recruiting
Karwan e Hayat
Karachi, Sindh
About this study
Official title: Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis: A Mixed Method Study
Young people constitute nearly half of Pakistan's population and are highly vulnerable to risk factors for mental illness, including poverty, inequality, abuse, and violence. Estimates suggest that 19-34% of children and adolescents experience emotional or behavioural disorders, though this is likely underestimated. In recent years, research has focused on those at imminent risk of developing serious conditions such as first episode psychosis. The concept of an At-Risk Mental State (ARMS) has highlighted the urgent need for interventions that address current symptoms, improve functioning, and reduce transition to psychosis.
Up to 80% of young people with ARMS have another diagnosable condition, and almost half show poor psychosocial outcomes even six years after initial help-seeking. Evidence demonstrates that early identification and treatment can delay or prevent psychosis, including severe and enduring illnesses like schizophrenia. Cognitive Behaviour Therapy (CBT) is among the most effective evidence-based approaches for this group. However, existing evidence comes largely from high-income countries, raising concerns about cultural applicability in low-resource settings.
This study will culturally adapt and field test a manualised CBT intervention for young people at risk of first episode psychosis. To our knowledge, this is the first such study in a low-income country. Findings will inform scalable, culturally relevant interventions for Pakistan and similar contexts.
Read the detailed description
Aims and Objectives:
The study has following aims and objectives:
- To culturally adapt the existing Cognitive Behavior Therapy for those at risk of first episode psychosis- "evidence-based therapy for people with ARMS" (Van der Gaag, et al., 2013).
- To field test the culturally adapted intervention in a randomised controlled trial
- To check whether adapted intervention reduces or delay the rates or incidence of transition from ARMS to first episode psychosis;
- To check whether adapted intervention improves other symptoms such as depression, anxiety and/or level of functioning in ARMS
- To explore the pereceived usefulness of intervention including perceived barriers and facilitators from different stakeholders' perspective.
Feasibility and acceptability of the intervention is defined as:
- Recruitment rates, attendance (attending more than 70% of intervention sessions)
- Acceptability of the intervention (based on participants satisfaction, attendance, attrition rates)
- Completeness of assessment tools and the assessment schedule by participants
- Preliminary efficacy of the intervention
- Being tested
- Cognitive Behavior Therapy for those at risk of first episode psychosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for those at risk of first episode psychosisBehavioural
Also called CBT-FEP
Participants will receive a culturally adapted manualised Cognitive Behavioural Therapy (CBT) for those at risk of first episode psychosis (FEP). The intervention aims to reduce symptoms, normalise psychosis-like experiences, and prevent catastrophic appraisals that may lead to delusions. It integrates psychoeducation, behavioural experiments, and techniques addressing cognitive biases. By reframing unusual experiences as perceptual or reasoning biases, distress and emotional arousal are reduced, lowering the chance of fixed, frightening beliefs. Homework tasks further support coping. CBT for At-Risk Mental States has shown effectiveness in reducing transition to psychosis and improving recovery. This study will adapt and field test the manual, with potential for remote delivery via phone, video, or AI tools to enhance accessibility.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy for those at risk of first episode psychosis | Experimental | The participants in the intervention group will receive a culturally adapted manualised cognitive behavioral therapy (CBT). The interventions aim to reduce symptoms, normalises psychosis-like experiences and prevents a catastrophic appraisal of the psychotic-like symptoms from occurring Receives: Behavioral: Cognitive Behavior Therapy for those at risk of first episode psychosis |
| Treatment as Usual | No intervention | Treatment As Usual (TAU): Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources. These participants will receive an initial assessment along with TAU as ascertained by their treating doctor at the hospital. In current practice, individuals with ARMS (at risk of first episode psychosis) are not routinely referred to any psychological service in Pakistan. TAU in Pakistan largely comprises of pharmacotherapy. Research staff will record the nature and intensity of the routine care delivered for each participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Indicator
feasibility will be determined by collecting data on recruitment and retention rates, The success criterion of feasibility will be to recruit > 50% of eligible participants
Measured: From baseline to 12th week (end of intervention)
Acceptability Indicator
Intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of >70%.
Measured: From baseline to 12th week (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individuals at Risk of First Episode PsychosisStudies 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
- Model description
- Cognitive Behavior Therapy for those at risk of first episode psychosis- "evidence-based therapy for people with ARMS" (Van der Gaag, et al., 2013). The participants in the intervention group will receive a culturally adapted manualised cognitive behavioral therapy (CBT). The interventions aim to reduce symptoms, normalises psychosis-like experiences and prevents a catastrophic appraisal of the psychotic-like symptoms from occurring.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ameer B Khoso, PhD, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188597
- Sponsor's protocol ID
- PILL-CBT ARMS-FEP
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT07188597
- Acronym / sponsor ID
- PILL-CBT ARMS-FEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Sep 2025 (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.
Young people constitute nearly half of Pakistan's population and are highly vulnerable to risk factors for mental illness, including poverty, inequality, abuse, and violence. Estimates suggest that 19-34% of children and adolescents experience emotional or behavioural disorders, though this is likely underestimated. In recent years, research has focused on those at imminent risk of developing serious conditions such as first episode psychosis. The concept of an At-Risk Mental State (ARMS) has highlighted the urgent need for interventions that address current symptoms, improve functioning, and reduce transition to psychosis.
Up to 80% of young people with ARMS have another diagnosable condition, and almost half show poor psychosocial outcomes even six years after initial help-seeking. Evidence demonstrates that early identification and treatment can delay or prevent psychosis, including severe and enduring illnesses like schizophrenia. Cognitive Behaviour Therapy (CBT) is among the most effective evidence-based approaches for this group. However, existing evidence comes largely from high-income countries, raising concerns about cultural applicability in low-resource settings.
This study will culturally adapt and field test a manualised CBT intervention for young people at risk of first episode psychosis. To our knowledge, this is the first such study in a low-income country. Findings will inform scalable, culturally relevant interventions for Pakistan and similar contexts.
Detailed description
Aims and Objectives:
The study has following aims and objectives:
- To culturally adapt the existing Cognitive Behavior Therapy for those at risk of first episode psychosis- "evidence-based therapy for people with ARMS" (Van der Gaag, et al., 2013).
- To field test the culturally adapted intervention in a randomised controlled trial
- To check whether adapted intervention reduces or delay the rates or incidence of transition from ARMS to first episode psychosis;
- To check whether adapted intervention improves other symptoms such as depression, anxiety and/or level of functioning in ARMS
- To explore the pereceived usefulness of intervention including perceived barriers and facilitators from different stakeholders' perspective.
Feasibility and acceptability of the intervention is defined as:
- Recruitment rates, attendance (attending more than 70% of intervention sessions)
- Acceptability of the intervention (based on participants satisfaction, attendance, attrition rates)
- Completeness of assessment tools and the assessment schedule by participants
- Preliminary efficacy of the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cognitive Behavior Therapy for those at risk of first episode psychosis- "evidence-based therapy for people with ARMS" (Van der Gaag, et al., 2013). The participants in the intervention group will receive a culturally adapted manualised cognitive behavioral therapy (CBT). The interventions aim to reduce symptoms, normalises psychosis-like experiences and prevents a catastrophic appraisal of the psychotic-like symptoms from occurring.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy for those at risk of first episode psychosis | Experimental | Behavioral: Cognitive Behavior Therapy for those at risk of first episode psychosisThe participants in the intervention group will receive a culturally adapted manualised cognitive behavioral therapy (CBT). The interventions aim to reduce symptoms, normalises psychosis-like experiences and prevents a catastrophic appraisal of the psychotic-like symptoms from occurring |
| Treatment as Usual | No intervention | –Treatment As Usual (TAU): Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources. These participants will receive an initial assessment along with TAU as ascertained by their treating doctor at the hospital. In current practice, individuals with ARMS (at risk of first episode psychosis) are not routinely referred to any psychological service in Pakistan. TAU in Pakistan largely comprises of pharmacotherapy. Research staff will record the nature and intensity of the routine care delivered for each participant. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female help-seeking individual aged 16-35 years;
- Score 6 or above on PQ-16
- Meet the at risk of FEP criteria using CAARMS Operationalized Intake Criteria based on three groups (vulnerability, attenuated psychosis or brief limited intermittent psychotic symptoms group);
- Assessed as competent to provide informed consent.
- Give written informed consent.
Key exclusion criteria (5 listed)
- Temporary resident unlikely to be available for follow up.
- Unable to engage, participate or respond to research questionnaires.
- a history of psychotic illness (treated or untreated).
- previous treatment with an antipsychotic or mood-stabilising agent.
- active substance abuse (except nicotine or caffeine) or dependence within the last three months, according to DSM-V criteria.
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 |
|---|---|---|
| Cognitive Behavior Therapy for those at risk of first episode psychosisAlso: CBT-FEPParticipants will receive a culturally adapted manualised Cognitive Behavioural Therapy (CBT) for those at risk of first episode psychosis (FEP). The intervention aims to reduce symptoms, normalise psychosis-like experiences, and prevent catastrophic appraisals that may lead to delusions. It integrates psychoeducation, behavioural experiments, and techniques addressing cognitive biases. By reframing unusual experiences as perceptual or reasoning biases, distress and emotional arousal are reduced, lowering the chance of fixed, frightening beliefs. Homework tasks further support coping. CBT for At-Risk Mental States has shown effectiveness in reducing transition to psychosis and improving recovery. This study will adapt and field test the manual, with potential for remote delivery via phone, video, or AI tools to enhance accessibility. | Behavioural | Cognitive Behavior Therapy for those at risk of first episode psychosis |
Primary outcome
Feasibility Indicator
Time frame: From baseline to 12th week (end of intervention)
feasibility will be determined by collecting data on recruitment and retention rates, The success criterion of feasibility will be to recruit > 50% of eligible participants
Acceptability Indicator
Time frame: From baseline to 12th week (end of intervention)
Intervention acceptability will be assessed using data on attendance. Criterion for acceptability is a mean attendance rate of >70%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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.
Ameer B Khoso, PhD principal investigator
Pakistan Institute of Living and Learning
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for those at risk of first episode psychosis in people with Individuals at Risk of First Episode Psychosis, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ameer B Khoso, PhD Fellow (009235871845, ameer.bukhsh@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Indicator (time frame: From baseline to 12th week (end of intervention)). 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 13 Apr 2026.