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NCT07188597
Culturally Adapted Cognitive Behavior Therapy for Individuals At Risk of First Episode Psychosis
NA trial testing Cognitive Behavior Therapy for those at risk of first episode psychosis in Individuals at Risk of First Episode Psychosis in 90 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Pakistan Institute of Living and Learning |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 January 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 2 locations across Pakistan |
Drugs / interventions tested
- Cognitive Behavior Therapy for those at risk of first episode psychosis
Conditions studied
- Individuals at Risk of First Episode Psychosis — all drugs for Individuals at Risk of First Episode Psychosis →
Sponsor
Pakistan Institute of Living and Learning
Who can join
Adults 16 to 35, any sex, with Individuals at Risk of First Episode Psychosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other Pakistan Institute of Living and Learning trials
Trials by the same sponsor.
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- NCT05933850 — Culturally Adapted Strong Families Programme for Families Living in Gilgit Baltistan, Pakistan · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07188597 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pakistan Institute of Living and Learning
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07188597.
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