Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07645443 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: FEEL-GOOD
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 8 of 14 entries
    • Study description shortened, about 9 words
    • Site details revised at 1 of 8 sites
  2. Re-verified, no change to tracked fieldsv3
  3. Secondary endpoints: details revised at 1 of 14 entries
    • Site contacts updated at 1 of 8 sites
    • Collaborators revised (9)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07645443
Lead Sponsor Stephanie Mehl
Collaborators: German Research Foundation, Central Institute of Mental Health, Mannheim, Ludwig-Maximilians - University of Munich, Charite University, Berlin, Germany, Vivantes Klinikum am Urban, Philipps University Marburg, University of Cologne, Universitätsklinikum Hamburg-Eppendorf, University Hospital Augsburg
Conditions
(from sponsor)		 Delusional Disorder, Brief Psychotic Disorder, Schizophreniform Disorder, Schizophrenia / Schizoaffective Disorder, Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition
Related terms Emotional Regulation, Psychotic Disorders, Schizophrenia, Schizophrenia, Paranoid
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov