nctId: NCT06286345 id: 17644 briefTitle: Lifestyle InterVEntion Study in General Practice: LIVES - GP acronym: LIVES-GP overallStatus: RECRUITING date: 2023-08-01 date: 2025-03-01 date: 2025-07-01 date: 2024-02-29 date: 2024-03-04 name: University Medical Center Groningen class: OTHER name: GGZ Drenthe Mental Health Institution briefSummary: Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore an 18 session multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply. conditions: Depression, Unipolar conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Uncontrolled cohort study primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: GLI-LEEF measure: Reach of GLI-LEEF measure: General practice adoption of GLI-LEEF measure: General practitioner adoption of GLI-LEEF measure: Lifestyle coach adoption of GLI-LEEF measure: Adherence to GLI-LEEF measure: Drop-out from GLI-LEEF measure: Barriers and facilitators of the GLI-LEEF implementation measure: Body weight of the participant as assessed by a medical weight scale measure: Body height of the participant as assessed by a stadiometer measure: Waist circumference of the participant as assessed using a tape meter line measure: Diastolic and systolic blood pressure as assessed using a sphygmomanometer measure: Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45) measure: Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC) measure: Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF) measure: Self esteem according to the Rosenberg Self-Esteem Scale (RSES) measure: Insomnia according to the Insomnia Severity Index (ISI) measure: Quality of life according to the Recovering Quality of Life (ReQol) measure: Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen status: RECRUITING city: Groningen zip: 9700 AD country: Netherlands name: Huibert Burger, MD PhD role: CONTACT phone: +31(0)50 361 6722 phoneExt: 6722 email: h.burger@umcg.nl name: Patrick Brink role: CONTACT phone: +31(0)50 361 6724 phoneExt: 6724 email: p.brink@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False