Clinical trial NCT05767073: LIVES: Personalized Lifestyle Intervention for Patients With Depression
Official title: LIVES: Development of/a Personalized Lifestyle Intervention for Patients With Depression in Psychiatric Outpatient Care and General Practice in a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Risk
Depression, Unipolar
Depression, Bipolar
Keywords: depression
lifestyle
mental health care
general practice
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: GGZ Drenthe Mental Health Institution
First posted: 2023-03-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Un controlled cohort study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reach of LIVE
timeFrame: 27 months (September 2020 through November 2022)
measure: Adherence to LIVE
timeFrame: 18 weeks
measure: Drop out from LIVE
timeFrame: 18 weeks
measure: Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 3
measure: Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 6
measure: Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 9
measure: Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 12
measure: Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 15
measure: Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 18
Secondary outcomes:
measure: Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 3
measure: Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 6
measure: Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 9
measure: Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 12
measure: Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 15
measure: Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis
timeFrame: Up to week 18
measure: Quality of life as assessed by The Manchester Short Assessment of Quality of Life (MANSA).
timeFrame: Baseline, at the end of the intervention 18 weeks after baseline, and at the 6 months follow up (42 weeks after baseline)
measure: Depressive symptoms according to the Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Recovery of the participant according to the Individual Recovery Outcomes Counter (I.ROC)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF)
timeFrame: Baseline, halfway and at the end of the intervention 18 weeks after the intervention, and at the 6 months follow up (42 weeks after baseline)
measure: Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Alcohol consumption and alcohol-related problems according to the Alcohol Use Disorders Identification test (AUDIT)
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Treatment success according to the Outcome Questionnaire-45
timeFrame: The questionnaire will be administered after every five modules of the intervention.
measure: Dietary intake of the participant according to a self devised questionnaire
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Activity level defined as the daily number of steps
timeFrame: From baseline up to the 6 months follow up (42 weeks after baseline)
measure: Body height of the participant as assessed by a stadiometer
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Body weight of the participant as assessed by a medical weight scale
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
measure: Waist circumference of the participant as assessed using a tape meter line
timeFrame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Other outcomes:
Locations:
city: Assen
country: Netherlands
facility: GGZ Drenthe
state: Drenthe
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Danielle Cath, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Marjolein Berger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.