Personalized lifestyle intervention for patients with depression
LIVES: Development of/a Personalized Lifestyle Intervention for Patients With Depression in Psychiatric Outpatient Care and General Practice in a Pilot Study
This study is testing a personalized lifestyle program to see if it can help people with bipolar disorder and severe depression improve their physical health and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 2 sites (Assen, Drenthe and 1 other locations) |
| Trial ID | NCT05767073 on ClinicalTrials.gov |
What this trial studies
This pilot intervention study aims to develop and assess a personalized lifestyle intervention tailored for patients with affective disorders, specifically focusing on those with bipolar disorder and severe recurrent depression. The study will evaluate the acceptability and feasibility of this intervention, which addresses the increased cardiovascular risks associated with these mental health conditions. Participants will undergo baseline measurements and various follow-up assessments to monitor their physical health and quality of life improvements throughout the intervention. The study will involve both outpatients in mental health care and patients from general practice settings.
Who should consider this trial
Good fit: Ideal candidates include outpatients aged 18-65 with chronic bipolar disorder or severe recurrent depression who are receiving psychopharmacological treatment and have metabolic parameters outside the normal range.
Not a fit: Patients with mild depressive symptoms who do not meet the inclusion criteria or those with other mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical health and quality of life for patients with depression and bipolar disorder.
How similar studies have performed: While lifestyle interventions have shown effectiveness in other populations, this specific personalized approach for patients with affective disorders is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For patients in mental health care only: * Outpatients * Diagnosed during intake, the primary diagnosis being chronic bipolar disorder (type I or 2) or a chronic or recurrent severe depression in the narrower sense of the word * Receiving psychopharmacological treatment * Have had a physical and lifestyle Routine Outcome Monitoring measurement showing that three or more metabolic parameters were outside the normal range For patients in general practice (GP) only: * 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, * At least mild depressive symptom level according to the Beck Depression Inventory-II (BDI) (score ≥14) * Body mass index ≥ 25 kg/m2 or increased waist circumference (\>88cm (women) of \>102cm (men)). For both patient groups: \- 18 years or older and capable to participate in the intervention according to the treating physician Availability of one or two people close to the patient (friends or family, preferably sharing the same household), i.e. to act as the buddy of the patient. Exclusion Criteria: * For GP patients only: current treatment in mental health care (GGZ in Dutch) * For GP patients only: severe somatic / neurological disease at the discretion of the GP * Currently participating in another lifestyle intervention * Insufficient proficiency in Dutch * Unability to read and write
Where this trial is running
Assen, Drenthe and 1 other locations
- GGZ Drenthe — Assen, Drenthe, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Danielle Cath, MD PhD — University Medical Center Groningen
- Study coordinator: Huibert Burger, MD PhD
- Email: h.burger@umcg.nl
- Phone: +31(0)50 361 6722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.