RecruitingNot ApplicableNCT05767073

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


Sponsor

University Medical Center Groningen

Enrollment

38 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria5

  • 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

Interventions

BEHAVIORALLifestyle 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.


Locations(2)

GGZ Drenthe

Assen, Drenthe, Netherlands

University Medical Center Groningen

Groningen, Netherlands

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NCT05767073


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