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FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis

NCT07645443

RecruitingNA

Sponsor: Stephanie Mehl

Conditions: Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia / Schizoaffective Disorder, Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition

Interventions: FEEL GOOD, Treatment as Usual (TAU)

Countries: Germany

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 overview

Sex: ALL

Age: 16 Years to 35 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (8)
  • Mannheim, Baden-Wurttemberg, Germany
  • Augsburg, Bavaria, Germany
  • München, Bavaria, Germany
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Marburg, Hesse, Germany
  • Cologne, North Rhine-Westphalia, Germany
  • Berlin, State of Berlin, Germany
  • Berlin, State of Berlin, Germany