Can mindfulness ease psychosis in teens and young adults?
NCT ID NCT07645443
First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 5 times
Summary
This study tests whether a 4-week mindfulness group therapy program, added to usual care, can reduce symptoms in 252 young people (ages 16-35) hospitalized for early psychosis. Participants are randomly assigned to either the mindfulness program plus standard treatment or standard treatment alone. The main goal is to see if mindfulness helps lower overall psychiatric symptoms after 4 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mindfulness-based group therapy
- What this could lead to
- If it works, this could offer a new, drug-free way to help young people manage psychosis symptoms during hospitalization.
- What could go wrong
- This is an early-stage trial with no phase, so results are uncertain. The therapy is added to standard care, so any benefit may be small or hard to separate from usual treatment.
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 252 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2028
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: * Age 16 to 35 years * Clinical diagnosis of early psychosis, defined as first psychotic episode within the last 5 years as assessed with the Structural Clinical Interview for DSM-5 Research Version (SCID-5-RV) * DSM-5 schizophrenia spectrum or other psychotic disorder confirmed with SCID-5-RV (DSM-5: 297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) Currently receiving inpatient/day clinic treatment with a planned stay of at least 4 weeks * Interested in and willing to participate in FEEL-GOOD and/or TAU. Exclusion Criteria: * Insufficient German language abilities * Acute suicidality or acute threat to others
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
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
8 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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Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
RECRUITINGBerlin, State of Berlin, 10117, Germany
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Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
RECRUITINGMünchen, Bavaria, 80336, Germany
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Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany
RECRUITINGMarburg, Hesse, 35039, Germany
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University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
RECRUITINGAugsburg, Bavaria, 86156, Germany
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University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
RECRUITINGCologne, North Rhine-Westphalia, 50937, Germany
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University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
RECRUITINGHamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
RECRUITINGMannheim, Baden-Wurttemberg, 68159, Germany
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Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin
RECRUITINGBerlin, State of Berlin, 10967, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists build a computer model of the brain to explain hearing voices
- Scientists probe brain's reward system in mental illness
- Can schools catch teen mental health struggles before they escalate?
- Zapping the Brain's 'Self' switch: can 10 hz current help schizophrenia?
- Can a phone app curb cannabis use in early psychosis?
- Brain zaps aimed at two networks may sharpen thinking in schizophrenia