protocolSection identificationModule nctId: NCT06286345, orgStudyIdInfo id: 17644, briefTitle: Lifestyle InterVEntion Study in General Practice: LIVES - GP, acronym: LIVES-GP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: GGZ Drenthe Mental Health Institution, descriptionModule 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., conditionsModule conditions: Depression, Unipolar, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Uncontrolled cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: GLI-LEEF, outcomesModule primaryOutcomes measure: Reach of GLI-LEEF, primaryOutcomes measure: General practice adoption of GLI-LEEF, primaryOutcomes measure: General practitioner adoption of GLI-LEEF, primaryOutcomes measure: Lifestyle coach adoption of GLI-LEEF, primaryOutcomes measure: Adherence to GLI-LEEF, primaryOutcomes measure: Drop-out from GLI-LEEF, primaryOutcomes measure: Barriers and facilitators of the GLI-LEEF implementation, secondaryOutcomes measure: Body weight of the participant as assessed by a medical weight scale, secondaryOutcomes measure: Body height of the participant as assessed by a stadiometer, secondaryOutcomes measure: Waist circumference of the participant as assessed using a tape meter line, secondaryOutcomes measure: Diastolic and systolic blood pressure as assessed using a sphygmomanometer, secondaryOutcomes measure: Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45), secondaryOutcomes measure: Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC), secondaryOutcomes measure: Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF), secondaryOutcomes measure: Self esteem according to the Rosenberg Self-Esteem Scale (RSES), secondaryOutcomes measure: Insomnia according to the Insomnia Severity Index (ISI), secondaryOutcomes measure: Quality of life according to the Recovering Quality of Life (ReQol), secondaryOutcomes measure: Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Groningen, status: RECRUITING, city: Groningen, zip: 9700 AD, country: Netherlands, contacts name: Huibert Burger, MD PhD, role: CONTACT, phone: +31(0)50 361 6722, phoneExt: 6722, email: h.burger@umcg.nl, contacts name: Patrick Brink, role: CONTACT, phone: +31(0)50 361 6724, phoneExt: 6724, email: p.brink@umcg.nl, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False