FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)
Stephanie Mehl
252 participants
May 27, 2026
INTERVENTIONAL
Conditions
Summary
FEEL-GOOD is a prospective multi-site single-blinded randomized controlled trial in young inpatients with acute early psychosis. Participants are randomized 1:1 to FEEL-GOOD plus treatment as usual (TAU) or TAU alone. The intervention consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. Outcomes are assessed at baseline, 4 weeks post-intervention, and 6 months follow-up, with the primary outcome being observer-rated total psychopathology as measured with the assessed by the total score of the Positive and Negative Syndrome Scale (PANSS) post-treatment (4 weeks post baseline).
Eligibility
Inclusion Criteria4
- 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 Criteria2
- Insufficient German language abilities
- Acute suicidality or acute threat to others
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Interventions
FEEL-GOOD consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. The core of the intervention will be to provide insights into and to practice the essential elements of mindfulness and emotion regulation: attention to the present moment, as well as non-judgmental awareness and acceptance, and application of emotional awareness and emotion regulation skills. The following modules will be provided: (1) Information on emotions (2 sessions); (2) How to use mindfulness to better cope with distressing emotions and symptoms. (2 sessions); (3) How to reduce vulnerability towards negative emotions (1 session) and (4) Regulation of specific distressing emotions (anger, guild and shame: 2 sessions) and (5) a last session on crisis planning.
Standard inpatient psychiatric treatment for early psychosis including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.
Locations(8)
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NCT07645443