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

7. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

140

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Atferdsmessig: 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.
Atferdsmessig: 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.
Atferdsmessig: Sleep intervention module
Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.
Atferdsmessig: Social prescribing module
Structured intervention to increase social participation, community engagement, and behavioral activation.
Enhet: Closed-loop transcranial alternating current stimulation (CL-tACS)
Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.
Aktiv komparator: 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.
Atferdsmessig: Structured lifestyle psychoeducation
Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.
Enhet: Sham CL-tACS
Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
Tidsramme: Baseline to Month 3
Change from baseline in the SF-36 Mental Component Summary score.
Baseline to Month 3

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6
Tidsramme: Baseline to Month 6
Baseline to Month 6
Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score
Tidsramme: 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
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in MATRICS Consensus Cognitive Battery
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Insomnia Severity Index (ISI)
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in UCLA Loneliness Scale score
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in International Physical Activity Questionnaire
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in EQ-5D-3L score
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Incidence of adverse events and serious adverse events
Tidsramme: Baseline through day 240-243
Baseline through day 240-243
Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Young Mania Rating Scale (YMRS)
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in step aerobic test performance
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in grip strength
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body weight
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body mass index (BMI)
Tidsramme: 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
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Chage in blood pressure
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in lean mass
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in fat mass
Tidsramme: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ludwig-Maximilians - University of Munich

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2028

Primær fullføring (Antatt)

1. juli 2030

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

9. april 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LIFETRAIN
  • U1111-1340-3272 (Annen identifikator: Universal Trial Number (UTN))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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