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).
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.
Insufficient German language abilities
Acute suicidality or acute threat to others
Parallel
FEEL GOOD
BehavioralFEEL-GOOD 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. 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.
Treatment as Usual (TAU)
Other interventionStandard inpatient psychiatric treatment for early psychosis including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.
Positive and Negative Symptom Scale Total Score (PANSS; Blinded assessment)
The primary outcome is observer-rated (blinded) total psychopathology as measured by the total score of PANSS after 4 weeks (t2). PANSS is widely used and the gold standard for psychopathological outcomes in people with psychotic disorders. It integrates positive, negative, and general psychopathological symptoms.
Positive and negative symptoms, general psychopathology as measured by PANSS Positive, Negative and General Psychopathology subscales (Blinded assessment)
The PANSS is a semi-structured interview to assess positive symptoms (PANSS Positive Scale), negative symptoms (PANSS Negative Scale) and general pathology (PANSS General Psychopathology Scale) of Psychosis.
Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator)
The FFMQ-D consists of 39 items forming the 5 subscales non-reactivity to inner experience, observing, acting with awareness, describing/labelling with words, and nonjudging of inner experience. Items are self-rated on a 5-point Likert-scale.
Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator)
Global self-esteem will be assessed with the RSES that consists of 10 items self-rated on a 4-point Likert-scale.
Ecological Momentary Assessment (EMA) (Self Report, putative mediator)
Participants will complete EMA via the m-Path mobile application starting after giving informed consent and randomisation into the trial and will end seven days post-intervention. There will be one prompt per day. Each prompt will include approximately 39-46 items, depending on conditional branching. The questions will cover several domains, such as current emotional state, psychopathological symptoms, mindfulness, emotional (in-)stability, and emotion regulation skills.
Childhood Trauma Questionnaire (CTQ) (Self Report)
The self-rating questionnaire Child Trauma Questionnaire (CTQ) consists of five subscales: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect, each comprising five items, and an additional minimization/denial scale consisting of 3 items. Items are rated on a 5-point Likert-Scale.
Cognitive Therapy Scale Revised for Psychosis (CTS-R-P)
The Cognitive Therapy Scale Revised for Psychosis (CTS-R-P) is used as an adapted version to assess video or audio recordings of the group intervention and the preparatory session to evaluate adherence to cognitive therapy principles and the overall competence of therapists delivering the intervention. A random selection of 25% of all recordings are assessed.
Mindfulness-Based Cognitive Therapy Adherence Scale (MBCT-AS)
Recordings of the group sessions are rated using the MBCT-AS in order to to assess how closely therapists adhere to the core principles and procedures of Mindfulness-Based Cognitive Therapy. A random selection of 25% of all recordings are assessed.
Structured Clinical Interview for DSM-5 (Research Version)
Diagnoses are confirmed using the structured interview SCID-5-RV. The SCID is an interview designed to systematically assess DSM-5 mental disorders for research purposes.
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Stephanie Mehl
Lead sponsor
Berlin Institute of Health @ Charité
Sponsor institution
German Research Foundation
Collaborator
Central Institute of Mental Health, Mannheim
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
Charite University, Berlin, Germany
Collaborator
Vivantes Klinikum am Urban
Collaborator
Philipps University Marburg
Collaborator
University of Cologne
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
University Hospital Augsburg
Collaborator