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

8 сентября 2026 г. обновлено: Stephanie Mehl

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).

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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).

Тип исследования

Интервенционный

Регистрация (Оцененный)

252

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Mara Bach
  • Номер телефона: +49 (0) 130 226095
  • Электронная почта: Mara.bach@charite.de

Учебное резервное копирование контактов

Места учебы

  • Германия
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Германия, 68159
        • Рекрутинг
        • University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
        • Контакт:
        • Главный следователь:
          • Andreas Meyer-Lindenberg, Prof. Dr.
        • Младший исследователь:
          • Dusan Hirjak, Prof. Dr.
    • Bavaria
      • Augsburg, Bavaria, Германия, 86156
        • Рекрутинг
        • University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
        • Контакт:
        • Главный следователь:
          • Alkomiet Hasan, Prof. Dr.
      • München, Bavaria, Германия, 80336
        • Рекрутинг
        • Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
        • Контакт:
        • Контакт:
        • Главный следователь:
          • Peter Falkai, Prof. Dr.
        • Младший исследователь:
          • Oliver Pogarell, Prof. Dr.
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Германия, 20246
        • Рекрутинг
        • University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
        • Главный следователь:
          • Jürgen Gallinat, Prof. Dr.
        • Контакт:
          • Schirin Gellert
          • Номер телефона: +49 (0) 40 7410 53210
          • Электронная почта: S.Gellert@uke.de
        • Младший исследователь:
          • Martin Lambert, Prof. Dr.
    • Hesse
      • Marburg, Hesse, Германия, 35039
        • Рекрутинг
        • Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany
        • Контакт:
          • Igor Nenadiç, Prof. Dr
          • Номер телефона: +49 (0) 6421 58 65002
          • Электронная почта: nenadic@uni-marburg.de
        • Контакт:
        • Главный следователь:
          • Igor Nenadiç, Prof. Dr.
        • Младший исследователь:
          • Stephanie Mehl, Prof. Dr.
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Германия, 50937
        • Рекрутинг
        • University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
        • Контакт:
        • Контакт:
          • Joseph Kambeitz, Prof. Dr.
          • Номер телефона: +49 (0) 221 478 87291
          • Электронная почта: joseph.kambeitz@uk-koeln.de
        • Главный следователь:
          • Frank Jessen, Prof. Dr.
        • Младший исследователь:
          • Joseph Kambeitz, Prof. Dr.
    • State of Berlin
      • Berlin, State of Berlin, Германия, 10117
        • Рекрутинг
        • Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
        • Контакт:
          • Kerem Böge, Prof. Dr. Dr
          • Номер телефона: +49 (0) 30 450 517 319
          • Электронная почта: kerem.boege@charite.de
        • Главный следователь:
          • Malek Bajbouj, Prof. Dr.
        • Младший исследователь:
          • Kerem Böge, Prof. Dr. Dr.
      • Berlin, State of Berlin, Германия, 10967
        • Рекрутинг
        • Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin
        • Контакт:
          • Andreas Bechdolf, Prof. Dr.
          • Номер телефона: +49 (0) 30 130 22 60 01
          • Электронная почта: andreas.bechdolf@vivantes.de
        • Главный следователь:
          • Andreas Bechdolf, Prof. Dr.
        • Младший исследователь:
          • Anja Lehmann, Dr.
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: FEEL-GOOD + TAU
FEEL-GOOD + TAU. FEEL-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. Patients additionally receive Treatment as Usual (TAU) as described below.
Поведенческий: FEEL GOOD
FEEL-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.
Активный компаратор: TAU
Participants receive treatment as usual (TAU), consisting of standard inpatient psychiatric care for early psychosis, including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.
Другой: Treatment as Usual (TAU)
Standard inpatient psychiatric treatment for early psychosis including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Positive and Negative Symptom Scale Total Score (PANSS; Blinded assessment)
Временное ограничение: Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3)
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.
Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Positive and negative symptoms, general psychopathology as measured by PANSS Positive, Negative and General Psychopathology subscales (Blinded assessment)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
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.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
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.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Global self-esteem will be assessed with the RSES that consists of 10 items self-rated on a 4-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Toronto Alexithymia Scale (TAS-26) (Self Report, putative mediator)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The TAS-26 is the German version of the TASand consists of 26 items with the 3 subscales: Difficulties Identifying Feelings, Difficulties Describing Feelings, and Externally Oriented Thinking self-rated on a 5-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Cognitive Emotion Regulation Questionnaire (CERQ) (Self Report, putative mediator)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The CERQ measures cognitive coping strategies, i.e., thoughts after negative events or situations on 9 subscales (self-blame, blaming others, acceptance, refocusing on planning, positive refocusing, rumination, positive reappraisal, putting into perspective, and catastrophizing), each consisting of 4 items that are self-rated on 5-point Likert-scales.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Emotion regulation skills (ERSQ) (Self Report, putative mediator)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The ERSQ consists of 27 items with 9 subscales assessing competencies that are considered essential for successful emotion regulation (i.e., attention, clarity, bodily awareness, understanding, acceptance, resilience, self-support, willingness to confront, and regulation). Self-reports are rated on a 5-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Patient satisfaction questionnaire (ZUF) (Self Report, putative mediator)
Временное ограничение: 4 weeks (t2), 6 months follow-up (t3)
The ZUF-8 is the German version adapted for inpatients based on the Client Satisfaction Questionnaire (CSQ-8). It consists of 8 items self-rated on a 4-point Likert-scale and assesses patients' overall satisfaction with the clinical treatment received.
4 weeks (t2), 6 months follow-up (t3)
World Health Organization Quality of Life - 100 item version (WHOQOL-BREF) (Self Report, putative mediator)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The WHOQOL-BREF assesses quality of life as a subjective evaluation, embedded within the individual's cultural, social, and environmental context using 26 items divided into 4 domains: physical health, psychological well-being, social relationships, and environment. Items are rated on a 5-point Likert-scale.
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)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The PSYRATS is a semi-structured interview to assess delusions and hallucinations. It consist of 17 items assessing specific dimensions of hallucinations and delusions. Each item is observer-rated on a 5-point scale ranging from 0 (= absent) to 4 (=severe). The PSYRATS include two subscales: hallucinations with 11 items (PSYRATS-H) and delusions with 6 items (PSYRATS-D).
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) (Blinded asessment)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The CDSS is considered as the gold standard to assess depression specifically in people with schizophrenia spectrum disorders. The 9 items are observer-rated on a scale ranging from 0 (=absent) to 3 (=severe). It distinguishes between depressive symptoms, positive, negative, and extrapyramidal symptoms in adolescents and adults
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Role Functioning Scale (RFS) (Blinded assessment)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The RFS is a semi-structured interview that measures performance on 4 single rating scales: working productivity, independent living, immediate social network relationships (friends and family), and extended social network relationships (other social contacts) with observer ratings from 0 (= minimal functioning) to 12 (= optimal functioning).
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Global Assessment of Functioning (GAF), (Blinded assessment)
Временное ограничение: Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)

In the GAF scale, clinicians rate a patient's overall level of psychological, social, and occupational functioning using a single score ranging from 1 to 100. A score of 100 represents superior functioning, whereas a score of 1 indicates a persistent risk of serious harm to oneself or others, severe impairment in basic self-care, or a suicidal act with clear expectation of death.

Changes of approximately 4, 10, or 12 points have been suggested to represent clinically meaningful differences [15].
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Serious adverse events (SAEs) (Blinded Assessment)
Временное ограничение: Continuously during intervention and follow-up
Serious adverse events are assessed and consist of suicidality, suicide attempts, death, life-threatening events or hospitalization (if patients were previously in outpatient treatment).
Continuously during intervention and follow-up
Ecological Momentary Assessment (EMA) (Self Report, putative mediator)
Временное ограничение: Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.
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.
Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Childhood Trauma Questionnaire (CTQ) (Self Report)
Временное ограничение: Baseline (t1)
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.
Baseline (t1)
Cognitive Therapy Scale Revised for Psychosis (CTS-R-P)
Временное ограничение: During the intervention period (4 weeks)
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.
During the intervention period (4 weeks)
Mindfulness-Based Cognitive Therapy Adherence Scale (MBCT-AS)
Временное ограничение: During the intervention period (4 weeks).
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.
During the intervention period (4 weeks).
Structured Clinical Interview for DSM-5 (Research Version)
Временное ограничение: Baseline (t1)
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.
Baseline (t1)
Assessment of withdrawal and reasons for withdrawal
Временное ограничение: During the intervention and at 6-months follow-up (T3)
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).
During the intervention and at 6-months follow-up (T3)
Assessment of Sociodemographic and Clinical Variables
Временное ограничение: Baseline (t1), 4 weeks (t2) and 6-months follow-up (t3)
Socio-demographic data will be collected by raters at baseline to describe the study population. Core variables include age, gender, education, migration background, residential status and employment status. Clinical variables include the number of previous hospitalisations and outpatient treatments, medication and duration of illness. Medication, hospitalisations and additional treatments will be assessed additionally post-intervention and at 6-months follow-up.
Baseline (t1), 4 weeks (t2) and 6-months follow-up (t3)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Stephanie Mehl

Соавторы

German Research Foundation
Charite University, Berlin, Germany
University of Cologne
Ludwig-Maximilians - University of Munich
Universitätsklinikum Hamburg-Eppendorf
Central Institute of Mental Health, Mannheim
University Hospital Augsburg
Vivantes Klinikum am Urban
Philipps University Marburg

Следователи

  • Главный следователь: Andreas Bechdolf, Prof. Dr., Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany
  • Учебный стул: Stephanie Mehl, Prof. Dr., Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

27 мая 2026 г.

Первичное завершение (Оцененный)

1 сентября 2028 г.

Завершение исследования (Оцененный)

31 декабря 2028 г.

Даты регистрации исследования

Первый отправленный

16 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

9 июня 2026 г.

Первый опубликованный (Действительный)

12 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

8 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • BE 3967/5-1 (Другой идентификатор: German Research Foundation (DFG))
  • EA2/287/25 (Другой идентификатор: Ethics Commission Charité Berlin)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Описание плана IPD

Patients will not be asked whether they consent to individual data sharing. It might be possible to share some individual anonymized data based on agreement of the Data Protection Official of each individual study site.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

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