NCT06286345

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

February 5, 2024

Last Update Submit

February 29, 2024

Conditions

Depression, UnipolarCardiovascular Diseases

Keywords

depressionlifestylegeneral practice

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (11)

  • 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 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)

  • 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)

  • 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)

  • 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)

  • +6 more secondary outcomes

Interventions

GLI-LEEFBEHAVIORAL

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Depressive DisorderCardiovascular DiseasesDepression

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Huibert Burger, MD PhD

CONTACT

+31(0)50 361 6722h.burger@umcg.nl

Jolien A Panjer, MD

CONTACT

+31(0)50 361 6722j.a.panjer@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Uncontrolled cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 29, 2024

Study Start

August 1, 2023

Primary Completion

March 1, 2025

Study Completion

July 1, 2025

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations

NL(1)