LIVES: Development of/a Personalized Lifestyle Intervention for Patients With Depression in Psychiatric Outpatient Care and General Practice in a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Reach of LIVE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention
Lifestyle intervention
干预措施: Lifestyle InterVEntion (LIVE) (Behavioral)
结局指标
主要结局
Reach of LIVE
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Feasibility and acceptability of the LIVE intervention according to the participant as assessed by qualitative interviews and qualitative data analysis
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Quality of life as assessed by The Manchester Short Assessment of Quality of Life (MANSA).(Baseline, at the end of the intervention 18 weeks after baseline, and at the 6 months follow up (42 weeks after baseline))
- Body weight of the participant as assessed by a medical weight scale(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis(Up to week 18)
- Recovery of the participant according to the Individual Recovery Outcomes Counter (I.ROC)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Body height of the participant as assessed by a stadiometer(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Depressive symptoms according to the Beck Depression Inventory-II (BDI-II)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(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)(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))
- Treatment success according to the Outcome Questionnaire-45(The questionnaire will be administered after every five modules of the intervention.)
- Alcohol consumption and alcohol-related problems according to the Alcohol Use Disorders Identification test (AUDIT)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Dietary intake of the participant according to a self devised questionnaire(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(From baseline up to the 6 months follow up (42 weeks after baseline))
- Waist circumference of the participant as assessed using a tape meter line(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Feasibility and acceptability of the LIVE intervention according to the buddy of the participant as assessed by qualitative interviews and qualitative data analysis(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(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(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(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(Up to week 15)