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

After providing written informed consent, participants diagnoses will be confirmed with SCID-5-RV interview. The investigator will complete astandardized screening checklist to verify that all inclusion and exclusion criteria are (not) met prior to enrollment in the study. If patients they meet the required inclusion criteria and the exclusion criteria participants will complete baseline data assessment before randomization which will be performed adaptively fromwithin the data management system SecuTrial. Subjects will be randomized in a 1:1 allocation for each study site and will be balanced adaptively for gender and symptom severity as meas-ured by the PANSS total score (3 strata: mild with \<54 points, moderate with 54-74 points, and high with \>74 points). Participants will further complete two assessments at 4-week and6-month post-intervention. The final assessment for each participant (t3) constitutes the individual end of study participation. As participation is voluntary, participants may withdraw from the study prematurely at any time. Any withdrawal, and the reason for withdrawal will be documented. Reasons for withdrawal may include: 1) withdrawal of consent by participant defined as drop-out (without the need to provide justification), or 2) incorrect inclusion (e.g., subsequent determination of ineligibility).

The FEEL-GOOD trial aims to evaluate a mindfulness-based group therapy for young inpatients with acute early psychosis in addition to treatment as usual (TAU) in comparison to TAU at post-intervention (t2 after 4 weeks) regarding total psychopathology, positive and negative symptoms, and general psychopathology measured with the Positive and Negative Symp-tom Scale (PANSS), as well as acceptance of symptoms, mind- fulness-related and emotion regulation skills in inpatients with EP in comparison to the control group only receiving TAU. The rationale is that early psychosis is a critical treatment window, while current psychological interventions show limited efficacy and low adherence in younger patients; mindfulness-based interventions (MBI) may improve emotional awareness, acceptance, and emotion regulation.

Participants aged 16 to 35 years with early psychosis are recruited across eight German study sites (inpatient hospitals).

FEEL-GOOD is delivered by trained clinical psychologists or psychiatrists and consists of one individual preparatory session and eight modularized 50-minute group sessions over four weeks. Clinical psychologists or psychiatrists will conduct the intervention based on a detailed manual. It will follow the principals of MBI adapted for patients with psychosis. The patients will join the group therapy sessions (open-enrolling group) at any time and then participate at 8 consecutive sessions. Prior to the first group session, there will be an individual session with the study therapist, in which the participants will discuss and write down individual treatment goals related to mindfulness, emotional awareness and emotion regulation.

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. The intervention was developed in cooperation with Peer Coworkers.

An earlier version of the FEEL-GOOD group intervention was piloted in a feasibility study at Vivantes Hospital Berlin.

Primary Outcome: The primary outcome will be observer-rated (blinded) total psychopathology as measured by the total score of the Positive and Negative Syndrome Scale (PANSS) \[post-treatment (4 weeks post baseline).

• Positive and negative symptoms, general psychopathology as measured by PANSS Positive, Negative and General Psychopathology subscales (Blinded assessment) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Ecological Momentary Assessment (EMA) (Self Report, putative mediator) [Time frame: Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.]
• Toronto Alexithymia Scale (TAS-26) (Self Report, putative mediator) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Cognitive Emotion Regulation Questionnaire (CERQ) (Self Report, putative mediator) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Emotion regulation skills (ERSQ) (Self Report, putative mediator) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Patient satisfaction questionnaire (ZUF) (Self Report, putative mediator) [Time frame: 4 weeks (t2), 6 months follow-up (t3)]
• World Health Organization Quality of Life - 100 item version (WHOQOL-BREF) (Self Report, putative mediator) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Psychotic Symptom Rating Scales to assess delusions (PSYRATS-D) and hallucinations (PSYRATS-H) (Blinded assessment) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) (Blinded asessment) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]
• Role Functioning Scale (RFS) (Blinded assessment) [Time frame: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)]