Lifestyle InterVEntion Study in General Practice: LIVES - GP (LIVES-GP)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Depression, Unipolar
• Intervention / Treatment: Behavioral: GLI-LEEF

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huibert Burger, MD PhD; Phone Number: 6722 +31(0)50 361 6722; Email: h.burger@umcg.nl
• Study Contact Backup: Name: Jolien A Panjer, MD; Phone Number: 6722 +31(0)50 361 6722; Email: j.a.panjer@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 AD
    • Recruiting
    • University Medical Center Groningen
    • Contact: Huibert Burger, MD PhD; Phone Number: 6722 +31(0)50 361 6722; Email: h.burger@umcg.nl
    • Contact: Patrick Brink; Phone Number: 6724 +31(0)50 361 6724; Email: p.brink@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of GLI-LEEF	Reach of GLI-LEEF as defined as the number of individuals who are willing to participate in this study	12 months
General practice adoption of GLI-LEEF	General practice adoption of GLI-LEEF as defined by the number of general practices that are willing to implement GLI-LEEF in this study	12 months
General practitioner adoption of GLI-LEEF	General practice adoption of GLI-LEEF as defined by the number of general practitioners that are willing to implement GLI-LEEF in this study	12 months
Lifestyle coach adoption of GLI-LEEF	Lifestyle coach adoption of GLI-LEEF as defined by the number of lifestyle coaches that are willing to implement GLI-LEEF in this study	12 months
Adherence to GLI-LEEF	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	18 weeks
Drop-out from GLI-LEEF	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	18 weeks
Barriers and facilitators of the GLI-LEEF implementation	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	18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: GGZ Drenthe Mental Health Institution

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: depression; lifestyle; general practice
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Cardiovascular Diseases
• Other Study ID Numbers: 17644

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No