LIVES: Personalized Lifestyle Intervention for Patients With Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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LIVES: Development of/a Personalized Lifestyle Intervention for Patients With Depression in Psychiatric Outpatient Care and General Practice in a Pilot Study

Conditions
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Cardiovascular Risk, Depression, Unipolar, Depression, Bipolar

Intervention / Treatment
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* Behavioral: LIVE


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Un controlled cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Lifestyle intervention | Behavioral: LIVE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach of LIVE | Reach of our intervention as defined by the absolute number, proportion, and representativeness of individuals who are willing to participate in LIVE | 27 months (September 2020 through November 2022) | 
| Adherence to LIVE | Adherence to the LIVE lifestyle intervention as defined by the number of sessions attended by the participant out of the total of 18 sessions | 18 weeks | 
| Drop out from LIVE | Drop-out from the LIVE intervention as defined by the proportion of participants who decide to prematurely stop taking part in the LIVE intervention | 18 weeks | 
| Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 3 | 
| Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 6 | 
| Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 9 | 
| Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 12 | 
| Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 15 | 
| Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability of the LIVE intervention will be assessed using qualitative interviews Participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability will be assessed using qualitative interviews. Buddies of participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 3 | 
| Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability will be assessed using qualitative interviews. Buddies of participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 6 | 
| Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability will be assessed using qualitative interviews. Buddies of participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 9 | 
| Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability will be assessed using qualitative interviews. Buddies of participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 12 | 
| Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability will be assessed using qualitative interviews. Buddies of participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 15 | 
| Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis | Feasibility and acceptability will be assessed using qualitative interviews. Buddies of participants will be interrogated on how they experienced themes during the different modules of the intervention. A topic-list will be used by the interviewer to check whether all relevant themes on feasibility and acceptability have been discussed | Up to week 18 | 
| Quality of life as assessed by The Manchester Short Assessment of Quality of Life (MANSA). | The MANSA measures quality of life focusing on satisfaction with life as a whole and with life domains and consists of a 12-item self-report questionnaire | Baseline, at the end of the intervention 18 weeks after baseline, and at the 6 months follow up (42 weeks after baseline) | 
| Depressive symptoms according to the Beck Depression Inventory-II (BDI-II) | The BDI-II is a self-report (21 items) rating inventory which measures depressive symptom level | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 
| Recovery of the participant according to the Individual Recovery Outcomes Counter (I.ROC) | The I.ROC is an instrument to quantitatively measure recovery. It uses three indicators on four areas of wellbeing, namely home, opportunity, people, empowerment. | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 
| Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF) | The MHC-SF measures emotional, social and psychological wellbeing and is a self-report with 14 items | 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) | 
| Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a self-report questionnaire that assesses sleep quality over a one-month interval and consists of 19 individual items. | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 
| Alcohol consumption and alcohol-related problems according to the Alcohol Use Disorders Identification test (AUDIT) | The AUDIT consists of 10 items scoring both consumption and alcohol-related problems. We will use the total scale on consumption and problem drinking | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 
| Treatment success according to the Outcome Questionnaire-45 | a questionnaire to measure treatment success. It has three subscales: 1. Symptomatic distress (25 items, including symptoms of depression, anxiety and drug dependency, 2. Interpersonal relations (11 items) en 3. Social Role (9 items) . | The questionnaire will be administered after every five modules of the intervention. | 
| Dietary intake of the participant according to a self deviced questionnaire | The questionnaire is a nutrition list with 25 items to measure the dietary intake of patients | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 
| Activity level defined as the daily number of steps | The daily number of steps will be measured using the Fitbit Zip as described by Naslund et al., 2016 | From baseline up to the 6 months follow up (42 weeks after baseline) | 
| Body height of the participant as assessed by a stadiometer | Body height in meters | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 
| Body weight of the participant as assessed by a medical weight scale | Body weight in kilograms | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 
| Waist circumference of the participant as assessed using a tape meter line | Waist circumference in centimeters | Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, lifestyle, mental health care, general practice