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

Sponsor
Ludwig-Maximilians - University of Munich
Study ID
NCT07586150
Status
Not Yet Recruiting

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Conditions

  • Bipolar Disorder (BD)
  • Depression / Major Depressive Disorder
  • Schizophrenia
  • Severe Mental Illness

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 31, 2028
Status verified
May 2026
Primary completion
Jul 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: 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.

Primary Outcome Measure

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

Central Contacts

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