NCT05767073

LIVES: 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Persons with affective disorder have a considerably increased risk of cardiovascular disease. To a considerable extent, this is due to an unhealthy life style. At present, no adequate lifestyle interventions are available for these patients. In the present pilot intervention study we study the acceptability and feasibility of a newly developed lifestyle intervention that is specifically tailored to the needs of patients with affective disorders treated in mental health care or general practice.

Detailed description

Rationale: Patients with bipolar disorder and severe depressions have a 10-year shorter life expectancy, on average, than the population as a whole. Also patients with less severe depression are still at a substantially increased risk of cardiovascular events. This may be attributed primarily to somatic complications resulting from a largely sedentary existence and an unhealthy lifestyle related to their disorder and/or the side effects of psychopharmacological treatment. Generally speaking, multimodal lifestyle interventions are about as effective as medication in reducing cardiovascular risks. Very little research has been conducted into the effect of lifestyle interventions among outpatients in mental health care or patients with mental health problems in general practice. This study seeks to examine the extent to which a personalised lifestyle approach can promote the physical health and quality of life of outpatients and general practice patients with affective disorders. Objective: The objective of this study is to develop a personalised state-of-the art lifestyle intervention that is both feasible and acceptable to outpatients with bipolar and severe recurrent depressive disorder and to patients with depression in general practice Study design: An explorative pilot study (n = 38) with baseline measurement and different follow-up measurements during and after the intervention. Study population: Patients (18-65 years old) with bipolar disorder or severe recurrent depression who are being treated at GGZ Drenthe (N=30) and patients with depression in primary care (N=8). Intervention (if applicable): A personalised multimodal lifestyle intervention consisting of several modules comprising both individual and group sessions. The support network is involved during the individual sessions. Main study parameters/endpoints: Feasibility and acceptability of the lifestyle intervention.

Conditions

• Cardiovascular Risk
• Depression, Unipolar
• Depression, Bipolar

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle InterVEntion (LIVE)	The lifestyle intervention Coaching on Lifestyle (CooL) (van Rinsum 2018)),formed the basis of LIVE and was adapted to specific dysfunctional elements in depressed patients regarding motivation and self-management. The focus is on reducing depressive symptoms, enhancing the quality of life and possibly achieving weight loss. The lifestyle intervention lasts six months, with 13 weekly 1.5 to 2 hour group sessions and five 45 to 60 -minute individual sessions with at least one person from the patient's support network of friends or family (preferably sharing the same household). All sessions end with individual homework exercises, and each session starts with a 10 to 15-minute positive psychology intervention (PPI) and 5 to 15 minutes of physical activity. These sessions are followed by two booster sessions after about two and six months. Groups consist of 4-8 people.

Timeline

• Start date: 2020-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-03-14
• Last updated: 2024-05-08

Locations

2 sites across 1 country: Netherlands