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)

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).

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).

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