Could a tailored talk therapy prevent psychosis in at-risk youth?
NCT ID NCT07188597
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a culturally adapted version of Cognitive Behavioral Therapy (CBT) for 90 young people aged 16-35 in Pakistan who show early signs of psychosis risk. The therapy aims to reduce distressing symptoms and prevent the development of full psychosis. Researchers will check if the approach is feasible and acceptable in a low-income country.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy (CBT)
- What this could lead to
- If successful, this could provide an effective, culturally appropriate therapy to reduce symptoms and prevent psychosis in low-resource settings.
- What could go wrong
- This is a small, early feasibility study (90 participants) in one country, so results may not apply elsewhere. The therapy may not work as well as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 35 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Commuity/Schools/Colleges
RECRUITINGKarachi, Sindh, Pakistan
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Karwan e Hayat
RECRUITINGKarachi, Sindh, Pakistan