Not yet recruiting NCT07586150
Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide (SEMA), Exercise module, Anti-inflammatory diet module, Sleep intervention module.
- Who it may be relevant to
- Registry conditions: Severe Mental Illness, Depression / Major Depressive Disorder, Bipolar Disorder (BD), Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies
Overview
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.
Interventions
- Drug 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. - Behavioral 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. - Behavioral 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. - Behavioral Sleep intervention module
Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management. - Behavioral Social prescribing module
Structured intervention to increase social participation, community engagement, and behavioral activation. - Device Closed-loop transcranial alternating current stimulation (CL-tACS)
Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. - Behavioral Structured lifestyle psychoeducation
Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation. - Device Sham CL-tACS
Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.
Primary outcome measures
- Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score [Time frame: Baseline to Month 3]
Secondary outcome measures (12)
- Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6 [Time frame: Baseline to Month 6]
- Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score [Time frame: Baseline to Month 3 and Month 6]
- Change in Short Form 36 Health Survey (SF-36) total score [Time frame: Baseline to Month 3 and Month 6]
- Change in MATRICS Consensus Cognitive Battery [Time frame: Baseline to Month 3 and Month 6]
- Change in Insomnia Severity Index (ISI) [Time frame: Baseline to Month 3 and Month 6]
- Change in UCLA Loneliness Scale score [Time frame: Baseline to Month 3 and Month 6]
- Change in International Physical Activity Questionnaire [Time frame: Baseline to Month 3 and Month 6]
- Change in EQ-5D-3L score [Time frame: Baseline to Month 3 and Month 6]
- Incidence of adverse events and serious adverse events [Time frame: Baseline through day 240-243]
- Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms [Time frame: Baseline to Month 3 and Month 6]
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: Baseline to Month 3 and Month 6]
- Change in Young Mania Rating Scale (YMRS) [Time frame: Baseline to Month 3 and Month 6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- Central Institute of Mental Health — Mannheim
- Department of Psychiatry and Psychotherapy, LMU Klinikum — München
Netherlands · 2 centers
- University Medical Center Groningen — Groningen
- University Medical Center Utrecht — Utrecht
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT07586150 · LIFETRAIN · U1111-1340-3272