Mindfulness-based group therapy in young inpatients with acute early psychosis - FEEL-GOOD

• Applicant: Professor Dr. Andreas Bechdolf
• Subject Area: Clinical Psychiatry, Psychotherapy, Child and Adolescent Psychiatry ; Public Health, Healthcare Research, Social and Occupational Medicine
• Term: since 2025
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 536597614

Psychotic disorders place a significant burden on individuals, families, and society, often becoming chronic. Early psychosis (EP) frequently progresses to schizophrenia, a condition that benefits from early intervention programs combining psychological, psychosocial, and pharmacological treatments. Despite advances, there remains a need for improved psychological interventions for EP. This trial aims to investigate the effects of mindfulness-based group therapy (FEEL-GOOD MBI) on overall psychopathology in young inpatients with acute EP. The study is a prospective multi-site randomized controlled open trial with blinded ratings (PROBE-design) across eight sites in Germany over 36 months. The participants are oung adults (16-35 years) diagnosed with EP (DSM-5: schizophrenia spectrum disorder and other psychotic disorders), within five years of onset, currently receiving inpatient care. The FEEL-GOOD MBI consists of 8 group sessions with individual practice assignments over 4 weeks and follows a standardized manual. The experimental group (FEEL-GOOD MBI + treatment as usual, TAU) will be compared to a control group (TAU alone) with pre- (T1), post-assessments (T2), and a six-month follow-up (T3). Therapist and raters will receive training und regular supervision sessions. Adherence to the MBI will be assessed using audiotapes and an Adherence and Competency Scale. We hypothesize that patients receiving the intervention will show greater reductions in overall psychopathology and improvements in symptom acceptance, mindfulness, and emotion regulation skills compared to the control group at T2. An additional aim is to assess changes in these outcomes using Ecological Momentary Assessment (EMA) to capture real-time effects in daily life. A total of 252 inpatients will be recruited over 22 months, with at least 188 patients included in the final analysis. The primary outcome is the change in psychopathology, as measured by the PANSS total score, between experimental and control group at 4 weeks. The primary analysis will be an intention-to-treat (ITT) analysis using a longitudinal mixed model. Secondary outcomes will be analyzed descriptively and according to variable type, using methods such as linear mixed models or mixed logistic regression. Mediation effects will be explored through path analysis in multi-level structural equation models, focusing on changes from T1 to T3. EMA data will also be analyzed using a longitudinal mixed model to account for the nested data structure. Safety will be closely monitored by tracking serious adverse events such as hospitalizations, suicidality, symptom deterioration, or life-threatening events. Positive results from this trial will support the inclusion of mindfulness-based interventions as a routine clinical treatment for inpatients with EP.

• DFG Programme: Clinical Trials
• Co-Investigator: Professorin Dr. Stephanie Mehl