LIVES: Personalized Lifestyle Intervention for Patients With Depression

NCT ID: NCT05767073

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Lifestyle intervention

Group Type: EXPERIMENTAL

Lifestyle InterVEntion (LIVE)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GGZ Drenthe Mental Health Institution

UNKNOWN

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Cath, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Marjolein Berger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

GGZ Drenthe

Assen, Drenthe, Netherlands

Site Status: RECRUITING

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Huibert Burger, MD PhD

Role: CONTACT

h.burger@umcg.nl

+31(0)50 361 6722 ext. 6722

Edith Liemburg, PhD

Role: CONTACT

e.j.liemburg@umcg.nl

+31 6 10589718 ext. 9718

Facility Contacts

Danielle Cath, MD PhD

Role: primary

danielle.cath@ggzdrenthe.nl

+31 6 82843069 ext. 3069

Edith Liemburg, PhD

Role: backup

e.j.liemburg@umcg.nl

+31 6 10589718

Huibert Burger, MD PhD

Role: primary

h.burger@umcg.nl

+31(0)50 361 6724 ext. 6724

Patrick Brink

Role: backup

p.brink@umcg.nl

+31 6 52724353

References

Ormel J, Von Korff M, Burger H, Scott K, Demyttenaere K, Huang YQ, Posada-Villa J, Pierre Lepine J, Angermeyer MC, Levinson D, de Girolamo G, Kawakami N, Karam E, Medina-Mora ME, Gureje O, Williams D, Haro JM, Bromet EJ, Alonso J, Kessler R. Mental disorders among persons with heart disease - results from World Mental Health surveys. Gen Hosp Psychiatry. 2007 Jul-Aug;29(4):325-34. doi: 10.1016/j.genhosppsych.2007.03.009.

Reference Type: BACKGROUND

PMID: 17591509 (View on PubMed)

Knol MJ, Heerdink ER, Egberts AC, Geerlings MI, Gorter KJ, Numans ME, Grobbee DE, Klungel OH, Burger H. Depressive symptoms in subjects with diagnosed and undiagnosed type 2 diabetes. Psychosom Med. 2007 May;69(4):300-5. doi: 10.1097/PSY.0b013e31805f48b9. Epub 2007 Apr 30.

Reference Type: BACKGROUND

PMID: 17470664 (View on PubMed)

Other Identifiers

11178

Identifier Type: -

Identifier Source: org_study_id