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

NCT07586150 · Not yet recruiting

Last updated 2026-05-28

This clinical trial tests personalized lifestyle and medication interventions in adults with severe mental illnesses like major depression, bipolar disorder, or schizophrenia to see how they affect mental health and quality of life.

Status Not yet recruiting Approved but enrollment has not started.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 140 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2028-10 · est. completion 2030-12

Where 5 sites · Austria, Germany, Netherlands

What this study is testing ClinicalTrials.gov NCT07586150 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide (SEMA) Drug

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.
Exercise module Behavioral

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.
Anti-inflammatory diet module Behavioral

Structured anti-inflammatory dietary intervention based on the Brain Anti-Inflammatory Nutrition (BrAIN) diet, supported by coaching, recipes, and digital materials.
Sleep intervention module Behavioral

Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.
Social prescribing module Behavioral

Structured intervention to increase social participation, community engagement, and behavioral activation.
Closed-loop transcranial alternating current stimulation (CL-tACS) Device

Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.
Structured lifestyle psychoeducation Behavioral

Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.
Sham CL-tACS Device

Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.

Main thing measured	Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
Sponsor	Ludwig-Maximilians - University of Munich
Conditions studied	Severe Mental Illness, Depression / Major Depressive Disorder, Bipolar Disorder (BD), Schizophrenia
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07586150 ↗