LIVES: Personalized Lifestyle Intervention for Patients With Depression

University Medical Center Groningen (UMCG)

Status

Enrolling

Conditions

Depression, Bipolar

Depression, Unipolar

Cardiovascular Risk

Treatments

Behavioral: Lifestyle InterVEntion (LIVE)

Study type

Interventional

Funder types

Other

Identifiers

NCT05767073

11178 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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