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Идёт набор NCT06415838

Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context

Без фазы С лечением Depression Depressive Symptoms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Brief Behavioral Activation, Care as Usual.
Кому может быть актуально
Состояния в реестре: Depression, Depressive Symptoms. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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

Вмешательства

  • Поведенческое Brief Behavioral Activation
    A five-session brief behavioral activation treatment delivered face-to-face in the participants' home. Session outline: Session 1: Psychoeducation about depression; treatment rationale for Behavioral Activation (BA); rationale and instructions for activity log Session 2: Discussion of life goals and values; planning of activities aligned with life goals and values for coming week Session 3: Troubleshooting any problems carrying out activities; planning activities aligned with life goals and
  • Другое Care as Usual
    Care as Usual provided by primary care and/or municipal care.

Первичные конечные точки

  • Montgomery-Åsberg Depression Rating Scale, MADRS-S [Срок оценки: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]
Вторичные конечные точки (9)
  • Geriatric Depression Scale 15, GDS-15 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]
  • Behavioral activation for depression scale - short form, BADS-SF [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швеция · 1 центр
  • Eskilstuna kommun — Eskilstuna

Идентификаторы

NCT: NCT06415838 · DePrevent

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗