An interventional study of GLI-LEEF in Depression, Unipolar and Cardiovascular Diseases, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment
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.
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)
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
GLI-LEEF is an 18-week program, during which various lifestyle topics are discussed, such as nutrition, exercise, sleep, relationships and intimacy, and specific education about depression and its influence on lifestyle. GLI-LEEF is aimed at improving the activity level, quality of life and (cardiovascular) health of patients and thus increasing the general functioning and well-being of patients and at the same time reducing psychological complaints. GLI-LEEF consists of 14 group meetings and 4 individual meetings, the group meetings last 90 minutes, the individual meetings 30 minutes. Patients are asked to wear a FitBit and to complete short homework assignments. Each group contains 8-10 patients. Patients are asked to find a buddy who can support them during the program.
Reach of GLI-LEEF
Reach of GLI-LEEF as defined as the number of individuals who are willing to participate in this study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 18 weeks
Body weight of the participant as assessed by a medical weight scale
Body weight in kilograms
Time frame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Body height of the participant as assessed by a stadiometer
Body height in meters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
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