Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN) (LIFETRAIN)
2026年5月7日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
140
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Peter Falkai, MD
- 電話番号：+49 89 4400 - 55501
- メール：peter.falkai@med.uni-muenchen.de
研究場所
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Groningen、オランダ、9713 GZ
- University Medical Center Groningen
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Utrecht、オランダ、3584 CX
- University Medical Center Utrecht
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Vienna、オーストリア、1090
- Medical University of Vienna
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Mannheim、ドイツ、68159
- Central Institute of Mental Health
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München、ドイツ、80336
- Department of Psychiatry and Psychotherapy, LMU Klinikum
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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.
Structured anti-inflammatory dietary intervention based on the Brain Anti-Inflammatory Nutrition (BrAIN) diet, supported by coaching, recipes, and digital materials.
Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.
Structured intervention to increase social participation, community engagement, and behavioral activation.
Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.
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アクティブコンパレータ：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.
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Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.
Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
時間枠：Baseline to Month 3
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Change from baseline in the SF-36 Mental Component Summary score.
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Baseline to Month 3
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6
時間枠：Baseline to Month 6
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Baseline to Month 6
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Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in Short Form 36 Health Survey (SF-36) total score
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in MATRICS Consensus Cognitive Battery
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in Insomnia Severity Index (ISI)
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in UCLA Loneliness Scale score
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in International Physical Activity Questionnaire
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in EQ-5D-3L score
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Incidence of adverse events and serious adverse events
時間枠：Baseline through day 240-243
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Baseline through day 240-243
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Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in Young Mania Rating Scale (YMRS)
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in Pittsburgh Sleep Quality Index (PSQI) scores
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in step aerobic test performance
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in grip strength
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in body weight
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in body mass index (BMI)
時間枠：Baseline to Month 3 and Month 6
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Weight and height will be combined to report BMI in kg/m^2
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Baseline to Month 3 and Month 6
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Change in waist-to-hip ratio
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Chage in blood pressure
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in lean mass
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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Change in fat mass
時間枠：Baseline to Month 3 and Month 6
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Baseline to Month 3 and Month 6
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2028年10月1日
一次修了 (推定)
2030年7月1日
研究の完了 (推定)
2030年12月1日
試験登録日
最初に提出
2026年4月9日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月7日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LIFETRAIN
- U1111-1340-3272 (その他の識別子：Universal Trial Number (UTN))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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