Clinical trial NCT06286345: Lifestyle InterVEntion Study in General Practice: LIVES - GP
Official title: Lifestyle InterVEntion Study in General Practice: LIVES - GP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Unipolar
Cardiovascular Diseases
Keywords: depression
lifestyle
general practice
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: GGZ Drenthe Mental Health Institution
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled cohort study
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Reach of GLI-LEEF
timeFrame: 12 months
measure: General practice adoption of GLI-LEEF
timeFrame: 12 months
measure: General practitioner adoption of GLI-LEEF
timeFrame: 12 months
measure: Lifestyle coach adoption of GLI-LEEF
timeFrame: 12 months
measure: Adherence to GLI-LEEF
timeFrame: 18 weeks
measure: Drop-out from GLI-LEEF
timeFrame: 18 weeks
measure: Barriers and facilitators of the GLI-LEEF implementation
timeFrame: 18 weeks
Secondary outcomes:
measure: Body weight of the participant as assessed by a medical weight scale
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Body height of the participant as assessed by a stadiometer
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Waist circumference of the participant as assessed using a tape meter line
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Diastolic and systolic blood pressure as assessed using a sphygmomanometer
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Self esteem according to the Rosenberg Self-Esteem Scale (RSES)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Insomnia according to the Insomnia Severity Index (ISI)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Quality of life according to the Recovering Quality of Life (ReQol)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: