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Depression, UnipolarLIVES-GPNCT06286345

Lifestyle InterVEntion Study in General Practice: LIVES - GP

A study testing GLI-LEEF in people with Depression, Unipolar and Cardiovascular Diseases, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Unipolar, Cardiovascular Diseases
What is being tested?
GLI-LEEF
How many people
50 participants
Where
1 siteNetherlands
Study dates
1 Aug 2023to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Huibert Burger, MD PhD contact

+31(0)50 361 6722 ext. 6722

h.burger@umcg.nl

Jolien A Panjer, MD contact

+31(0)50 361 6722 ext. 6722

j.a.panjer@umcg.nl

Netherlands1 site, 1 recruiting

  • University Medical Center Groningen

    Groningen, 9700 AD

    Huibert Burger, MD PhD, +31(0)50 361 6722 ext. 6722, h.burger@umcg.nl

    Patrick Brink, +31(0)50 361 6724 ext. 6724, p.brink@umcg.nl

    Recruiting

Other trials in Netherlands

About this study

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.

Read the 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)

Being tested
GLI-LEEF
Keywords
depression, lifestyle, general practice
Medical subject headings
Depressive Disorder, Cardiovascular Diseases, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLI-LEEFBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reach of GLI-LEEF

    Reach of GLI-LEEF as defined as the number of individuals who are willing to participate in this study

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 18 weeks

  6. 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

    Measured: 18 weeks

  7. 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

    Measured: 18 weeks

Secondary outcomes (11)

  1. Body weight of the participant as assessed by a medical weight scale

    Body weight in kilograms

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  2. Body height of the participant as assessed by a stadiometer

    Body height in meters

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  3. Waist circumference of the participant as assessed using a tape meter line

    Waist circumference in centimeters

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  4. Diastolic and systolic blood pressure as assessed using a sphygmomanometer

    Diastolic and systolic blood pressure in millimeters mercury

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  5. 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

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  6. 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.

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  7. 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.

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  8. 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.

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  9. 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.

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  10. 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.

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

  11. 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

    Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start1 Aug 2023
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Uncontrolled cohort study
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286345
Sponsor's protocol ID
17644
Acronym
LIVES-GP
Status last verified
Feb 2024
First submitted
5 Feb 2024
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing GLI-LEEF in people with Depression, Unipolar and Cardiovascular Diseases, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huibert Burger, MD PhD (+31(0)50 361 6722 ext. 6722, h.burger@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach of GLI-LEEF (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06286345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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