Study S001994

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT07586150
Acronym: LIFETRAIN
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Masking: SINGLE
Status: NOT_YET_RECRUITING
Enrollment: 140
Start: 2028-10
Primary completion: 2030-07
Lead sponsor: Ludwig-Maximilians - University of Munich
Conditions: Severe Mental Illness; Depression / Major Depressive Disorder; Bipolar Disorder (BD); Schizophrenia
Interventions: DRUG:Semaglutide (SEMA); BEHAVIORAL:Exercise module; BEHAVIORAL:Anti-inflammatory diet module; BEHAVIORAL:Sleep intervention module; BEHAVIORAL:Social prescribing module; DEVICE:Closed-loop transcranial alternating current stimulation (CL-tACS); BEHAVIORAL:Structured lifestyle psychoeducation; DEVICE:Sham CL-tACS
Results posted: FALSE
Individual participant data sharing: UNDECIDED
Secondary identifiers: OTHER:U1111-1340-3272

Registered primary outcomes

Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score [Baseline to Month 3]

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