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

7 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.
Gedragsmatig: 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.
Gedragsmatig: 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.
Gedragsmatig: Sleep intervention module
Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.
Gedragsmatig: Social prescribing module
Structured intervention to increase social participation, community engagement, and behavioral activation.
Apparaat: Closed-loop transcranial alternating current stimulation (CL-tACS)
Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.
Actieve vergelijker: 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.
Gedragsmatig: Structured lifestyle psychoeducation
Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.
Apparaat: Sham CL-tACS
Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
Tijdsspanne: Baseline to Month 3
Change from baseline in the SF-36 Mental Component Summary score.
Baseline to Month 3

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ludwig-Maximilians - University of Munich

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2028

Primaire voltooiing (Geschat)

1 juli 2030

Studie voltooiing (Geschat)

1 december 2030

Studieregistratiedata

Eerst ingediend

9 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LIFETRAIN
  • U1111-1340-3272 (Andere identificatie: Universal Trial Number (UTN))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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