Lifestyle InterVEntion Study in General Practice: LIVES - GP

Not Applicable

Recruiting

• Conditions: Depression, Unipolar; Cardiovascular Diseases

• Registration Number: NCT06286345
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Rationale: 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 a 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 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.

Objective: to estimate in general practice the feasibility of conducting a large-scale study on the effectiveness of a MLI for depression, and identify key factors that can influence its successful conduct. In addition, this study aims to obtain an estimate of the variance of outcome measures (mental health, lifestyle factors, functioning, recovery, wellbeing, sleeping quality, self-esteem, quality of life, health care costs, anthropometry and blood pressure).

Study design: An observational single-group prospective cohort study (n = 50) using mixed methods with baseline measurement and two follow-up measurements: after the intervention at 18 weeks and after a follow-up at 42 weeks.

Study population: Patients (18 years or over) with depression and overweight who are being treated in general practice.

Intervention (if applicable): A MLI named (in Dutch) "Gecombineerde Leefstijl Interventie Leef" (GLI-LEEF), developed for patients with depression consisting of several modules (e.g. on physical activity, healthy diet) comprising both individual and group sessions.

Main study parameters/endpoints: implementation feasibility using three of the elements of the 'Reach, Effectiveness, Adoption, Implementation, Maintenance' (RE-AIM) framework for process evaluation (i.e. Reach, Adoption and Implementation)

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-29
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-03-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of depressive symptoms or depressive disorder in the past year as registered in the general practice electronic health record and coded according to the International Classification of Primary Care (ICPC) as P03 and P76, respectively, or currently treated for depressive symptoms or depressive disorder in general practice.
• At least mild depressive symptom level according to the Quick Inventory Depressive Symptomatology-Self-Report (QIDS-SR) (score ≥6)
• Body mass index ≥ 25 kg/m2 or increased waist circumference (>88 cm (women) of >102 cm (men)).

Exclusion Criteria

• Current treatment in mental health care (GGZ in Dutch)
• Severe somatic / neurological disease at the discretion of the GP
• Currently participating in another lifestyle intervention
• Insufficient proficiency in Dutch
• Inability to read and write

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
General practitioner adoption of GLI-LEEF	12 months	General practice adoption of GLI-LEEF as defined by the number of general practitioners that are willing to implement GLI-LEEF in this study
Lifestyle coach adoption of GLI-LEEF	12 months	Lifestyle coach adoption of GLI-LEEF as defined by the number of lifestyle coaches that are willing to implement GLI-LEEF in this study
Barriers and facilitators of the GLI-LEEF implementation	18 weeks	Potential barriers and facilitators of the GLI-LEEF implementation will be identified using a qualitative approach by interviewing approximately 10 participants who dropped out and 10 who completed GLI-LEEF, if opportune
General practice adoption of GLI-LEEF	12 months	General practice adoption of GLI-LEEF as defined by the number of general practices that are willing to implement GLI-LEEF in this study
Adherence to GLI-LEEF	18 weeks	First aspect of implementation is adherence to GLI-LEEF which is defined by the number of sessions attended by the participant out of the total of 18 sessions
Reach of GLI-LEEF	12 months	Reach of GLI-LEEF as defined as the number of individuals who are willing to participate in this study
Drop-out from GLI-LEEF	18 weeks	Second aspect of implementation is drop-out from GLI-LEEF which is defined by the proportion of participants who decide to prematurely stop taking part in the intervention

Secondary Outcome Measures

Name	Time	Method
Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45)	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	The OQ-45 runs from 0 to 180. The lower the score, the more successful treatment
Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC)	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	The I.ROC is an instrument to quantitatively measure recovery. The total score runs from 12 to 72. Higher scores indicate better outcomes.
Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF)	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	The MHC-SF measures emotional, social and psychological wellbeing. Its total score runs from 0 to 20. Higher score means better outcome.
Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	The TiC - P assesses health care consumption and productivity loss in patients with mental illness
Body weight of the participant as assessed by a medical weight scale	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	Body weight in kilograms
Body height of the participant as assessed by a stadiometer	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	Body height in meters
Insomnia according to the Insomnia Severity Index (ISI)	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	The ISI assesses insomnia. The total score runs from 0 to 28. Higher score means worse outcome.
Waist circumference of the participant as assessed using a tape meter line	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	Waist circumference in centimeters
Self esteem according to the Rosenberg Self-Esteem Scale (RSES)	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	The RSES is a widely used self-report instrument for evaluating individual self-esteem. The total score runs from 0 to 30. Higher score means worse outcome, i.e. less self-esteem.
Diastolic and systolic blood pressure as assessed using a sphygmomanometer	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	Diastolic and systolic blood pressure in millimeters mercury
Quality of life according to the Recovering Quality of Life (ReQol)	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)	This is a Patient Reported Outcome Measure assesses the quality of life for people with different mental health conditions. Its score runs from 0 to 80. Higher score means better outcome.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands