Cardiovascular RiskLIVESNCT05767073
LIVES: Personalized Lifestyle Intervention for Patients With Depression
A study testing Lifestyle InterVEntion (LIVE) in people with Cardiovascular Risk and Depression, Unipolar, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk, Depression, Unipolar, Depression, Bipolar
- What is being tested?
- Lifestyle InterVEntion (LIVE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Sep 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
GGZ Drenthe
Assen, Drenthe, 9404 LA
Danielle Cath, MD PhD, +31 6 82843069 ext. 3069, danielle.cath@ggzdrenthe.nl
Edith Liemburg, PhD, +31 6 10589718, e.j.liemburg@umcg.nl
- Recruiting
University Medical Center Groningen
Groningen, 9700 AD
Huibert Burger, MD PhD, +31(0)50 361 6724 ext. 6724, h.burger@umcg.nl
Patrick Brink, +31 6 52724353, p.brink@umcg.nl
About this study
Official title: LIVES: Development of/a Personalized Lifestyle Intervention for Patients With Depression in Psychiatric Outpatient Care and General Practice in a Pilot Study
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.
Read the 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.
- Being tested
- Lifestyle InterVEntion (LIVE)
- Keywords
- depression, lifestyle, mental health care, general practice
- Medical subject headings
- Depressive Disorder, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterVEntion (LIVE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lifestyle intervention Receives: Behavioral: Lifestyle InterVEntion (LIVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to week 18
Secondary outcomes (18)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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) .
Measured: The questionnaire will be administered after every five modules of the intervention.
Dietary intake of the participant according to a self devised questionnaire
The questionnaire is a nutrition list with 25 items to measure the dietary intake of patients
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Sep 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Un controlled cohort study
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- GGZ Drenthe Mental Health Institution
- Responsible party
- Sponsor
- Investigators
- Danielle Cath, MD PhD, Principal investigator, University Medical Center GroningenMarjolein Berger, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767073
- Sponsor's protocol ID
- 11178
- Acronym
- LIVES
- Status last verified
- May 2024
- First submitted
- 16 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17591509Knol 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.
PubMed 17470664
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIVES: Development of/a Personalized Lifestyle Intervention for Patients With Depression in Psychiatric Outpatient Care and General Practice in a Pilot Study
- ClinicalTrials.gov ID
- NCT05767073
- Acronym / sponsor ID
- LIVES / 11178
- Keywords
- depression, lifestyle, mental health care, general practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- GGZ Drenthe Mental Health Institution
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Un controlled cohort study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Lifestyle InterVEntion (LIVE)Lifestyle intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Reach of LIVE
Time frame: 27 months (September 2020 through November 2022)
Reach of our intervention as defined by the absolute number, proportion, and representativeness of individuals who are willing to participate in LIVE
Adherence to LIVE
Time frame: 18 weeks
Adherence to the LIVE lifestyle intervention as defined by the number of sessions attended by the participant out of the total of 18 sessions
Drop out from LIVE
Time frame: 18 weeks
Drop-out from the LIVE intervention as defined by the proportion of participants who decide to prematurely stop taking part in the LIVE intervention
Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
Time frame: Up to week 3
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
Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
Time frame: Up to week 6
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
Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
Time frame: Up to week 9
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
Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
Time frame: Up to week 12
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
Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
Time frame: Up to week 15
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
Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
Time frame: Up to week 18
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
18 secondary outcomes
Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to week 18
Quality of life as assessed by The Manchester Short Assessment of Quality of Life (MANSA).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: The questionnaire will be administered after every five modules of the intervention.
Dietary intake of the participant according to a self devised questionnaire
Time frame: 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
Time frame: From baseline up to the 6 months follow up (42 weeks after baseline)
Body height of the participant as assessed by a stadiometer
Time frame: 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
Time frame: 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
Time frame: Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 17591509Ormel 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.
- Background: PubMed 17470664Knol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Cath, MD PhD principal investigator
University Medical Center Groningen
Marjolein Berger, MD PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle InterVEntion (LIVE) in people with Cardiovascular Risk and Depression, Unipolar, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huibert Burger, MD PhD (+31(0)50 361 6722 ext. 6722, h.burger@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach of LIVE (time frame: 27 months (September 2020 through November 2022)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05767073, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.