Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale, MADRS-S
研究概览
简要总结
The goal of this randomized clinical trial is to investigate if a brief psychological treatment called Behavioral Activation (BA) works to prevent and treat depression in older adults in a municipal context in Sweden. It will also learn about the patients' and therapists' experiences of the BA-treatment.
The main questions it aims to answer are if the BA-treatment has an effect on the short and long term on:
- Depressive symptoms
- Anxiety symptoms
- Self-rated activation
- Functional ability
- Loneliness
- Self efficacy
- Mental wellbeing
- Quality of life
- Need for community care services
All participants will continue their care as usual (CAU), and half of the participants will be randomized to receive a five-session BA-treatment spread over two months as an add-on to CAU. All participants will answer a questionnaire in the beginning of the study, after two months, and after 3-, 6- and 12 months.
详细描述
One third of the Swedish population aged 70 years and above report depressive symptoms, and between 5 - 15% have a major depressive disorder. Depression in older adults reduces quality of life and functional ability, and is associated with an increased risk for morbidity and mortality. Psychological treatment is considered a first-line treatment for depression, but is currently only offered to about 3% of older adults with depression in Sweden. A majority of older adults suffering from depression in Sweden are likely not to be identified and diagnosed, and thereby not treated for their depression. Furthermore, many older adults receive municipal care, and psychological treatment is currently not available in this context.
The goal of this randomized clinical trial is to investigate if a brief psychological treatment called Behavioral Activation (BA) works to prevent and treat depression in older adults in a municipal context in Sweden. It will also learn about the patients' and therapists' experiences of the BA-treatment. The therapists in the trial are social workers working in Eskilstuna municipality in Sweden.
All participants will continue their care as usual (CAU), and half of the participants will be randomized to receive a five-session BA-treatment spread over two months as an add-on to CAU. The BA-treatment will be delivered in the participants' home. All participants will answer a questionnaire in the beginning of the study, after two months, and after 3-, 6- and 12 months.
The main questions that the trial aims to answer are if the BA-treatment has an effect on the short and long term on:
- Depressive symptoms
- Anxiety symptoms
- Self-rated activation
- Functional ability
- Loneliness
- Self efficacy
- Mental wellbeing
- Quality of life
- Need for community care services
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years or older
- •5 points or above on the Geriatric Depression Scale 15, GDS-15
- •Fluent in written and spoken Swedish
- •Consents to participate in the trial
排除标准
- •Not able to use the patient materials due to visual impairment
- •Not able to communicate with therapist due to hearing impairment
- •Diagnosis of major neurocognitive disorder
- •Below 25 points on the Mini Mental State Examination, MMSE
- •Elevated suicide risk
- •Current substance- or alcohol use disorder
- •Previous or current psychotic disorder
- •Previous or current bipolar disorder
- •Ongoing psychological treatment/pscyhotherapy
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale, MADRS-S
时间窗: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
Depressive symptoms will be measured with the Montgomery-Åsberg Depression Rating Self-rating Scale (MADRS-S). The MADRS-S is a nine-item questionnaire designed to measure depression severity during the past two weeks. The total score ranges from 0-54, with higher scores indicating higher depression severity.
次要结局
- Behavioral activation for depression scale - short form, BADS-SF(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWBS(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- Geriatric Depression Scale 15, GDS-15(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- WHO disability assessment schedule 12-item, WHODAS-12(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- The New General Self-Efficacy Scale, S-GSE(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- Need for municipal care service(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- Geriatric Anxiety Scale 10, GAS-10(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)
- UCLA Loneliness Scale version 3, UCLA-LS 3(Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group)