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Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN) (LIFETRAIN)

7 de mayo de 2026 actualizado por: Isabel Maurus, Ludwig-Maximilians - University of Munich

Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies

This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Mannheim, Alemania, 68159
        • Central Institute of Mental Health
      • München, Alemania, 80336
        • Department of Psychiatry and Psychotherapy, LMU Klinikum
  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Países Bajos
      • Groningen, Países Bajos, 9713 GZ
        • University Medical Center Groningen
      • Utrecht, Países Bajos, 3584 CX
        • University Medical Center Utrecht

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age 18 to 65 years
  • Able and willing to provide written informed consent
  • Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.
  • Female participants of childbearing potential must agree to use an effective method of contraception
  • Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks
  • Reduced functioning at screening defined as SF-36 score less than or equal to 40
  • If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day
  • Stable somatic condition for at least 4 weeks
  • For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg/m² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg/m²
  • For optional adaptive neurostimulation: MADRS score at least 19
  • Expected ability to comply with study procedures in the investigator's judgment

Exclusion Criteria:

  • Unable to provide informed consent
  • Current or past neurological disorder or structural brain pathology that may affect study procedures
  • Known intolerance or hypersensitivity to semaglutide
  • Pregnancy or lactation
  • Serious suicidal risk
  • Substance dependence within the last 3 months
  • BMI less than 18.5 kg/m²
  • eGFR less than 30 mL/min/1.73 m²
  • Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes
  • Pancreatitis, history of pancreatitis, or pancreatic cancer
  • Multiple endocrine neoplasia type 2 or personal/family history of medullary thyroid cancer
  • Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis
  • Need for acute surgery
  • Other medical condition that may affect study procedures or participant safety
  • For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Personalized pharmaco-lifestyle intervention
Participants receive one or more individualized intervention modules selected according to predefined eligibility criteria, digital guidance, and shared decision-making. Modules may include exercise, anti-inflammatory diet, sleep intervention, social prescribing, semaglutide, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. Weekly guided support is provided through Month 3, followed by self-directed continuation with digital support through Month 6.
Droga: Semaglutide (SEMA)
Once-weekly subcutaneous semaglutide for eligible participants with overweight or obesity and metabolic risk, titrated according to protocol up to 2.4 mg/week as tolerated, followed by tapering after Month 6.
Conductual: Exercise module
Personalized moderate-intensity exercise intervention with supervised sessions during the structured phase and supported maintenance, targeting at least 150 minutes of moderate physical activity per week.
Conductual: Anti-inflammatory diet module
Structured anti-inflammatory dietary intervention based on the Brain Anti-Inflammatory Nutrition (BrAIN) diet, supported by coaching, recipes, and digital materials.
Conductual: Sleep intervention module
Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.
Conductual: Social prescribing module
Structured intervention to increase social participation, community engagement, and behavioral activation.
Dispositivo: Closed-loop transcranial alternating current stimulation (CL-tACS)
Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.
Comparador activo: Structured lifestyle psychoeducation control
Participants receive structured psychoeducation and counseling on exercise, diet, sleep, and social contact approximately every four weeks through Month 3, followed by self-guided continuation through Month 6. Participants with prominent depressive symptoms may receive sham closed-loop transcranial alternating current stimulation.
Conductual: Structured lifestyle psychoeducation
Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.
Dispositivo: Sham CL-tACS
Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
Periodo de tiempo: Baseline to Month 3
Change from baseline in the SF-36 Mental Component Summary score.
Baseline to Month 3

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6
Periodo de tiempo: Baseline to Month 6
Baseline to Month 6
Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Short Form 36 Health Survey (SF-36) total score
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in MATRICS Consensus Cognitive Battery
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Insomnia Severity Index (ISI)
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in UCLA Loneliness Scale score
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in International Physical Activity Questionnaire
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in EQ-5D-3L score
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Incidence of adverse events and serious adverse events
Periodo de tiempo: Baseline through day 240-243
Baseline through day 240-243
Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Young Mania Rating Scale (YMRS)
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in step aerobic test performance
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in grip strength
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body weight
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body mass index (BMI)
Periodo de tiempo: Baseline to Month 3 and Month 6
Weight and height will be combined to report BMI in kg/m^2
Baseline to Month 3 and Month 6
Change in waist-to-hip ratio
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Chage in blood pressure
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in lean mass
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in fat mass
Periodo de tiempo: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ludwig-Maximilians - University of Munich

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2028

Finalización primaria (Estimado)

1 de julio de 2030

Finalización del estudio (Estimado)

1 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

9 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de mayo de 2026

Publicado por primera vez (Actual)

14 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • LIFETRAIN
  • U1111-1340-3272 (Otro identificador: Universal Trial Number (UTN))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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