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Идёт набор NCT07028983

Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music

Без фазы С лечением Substance Use Disorder (SUD)

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: Active Music Group (AMG), Music Listening Group (MLG), Treatment as Usual (TAU).
Кому может быть актуально
Состояния в реестре: Substance Use Disorder (SUD). Базовые параметры: от 18 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
Австрия, Израиль, Италия, Норвегия, Palestinian Territories +3
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Fighting Addictions, Improving Lives Through COmprehensive Drug Rehabilitation With Music (FALCO): International Randomised Controlled Trial

Обзор

FALCO is a parallel pragmatic randomized control trial addressing long-term effects of music therapy (MT) on substance use disorder (SUD). 600 participants will be recruited from multiple European countries (see Locations). They will be randomized into one of the following intervention arms: Active Music Group (AMG), Music Listening Group (MLG) or Treatment as Usual (TAU) as offered locally.

Подробное описание

Substance use disorder (SUD) is associated with a high global burden of disease: 4.2% of all disability-adjusted life years lost (DALYs, a combined measure of years of life lost and years lived with disability) are due to alcohol and 1.3% due to illicit drugs. Remarkably, approved pharmacological treatment options are not available for most SUDs, and non-pharmacological approaches are still the backbone of SUD treatment.

Music therapy (MT) is a non-pharmacological intervention recommended i some SUD guidelines. In MT, defined as the clinical and evidence-based use of music interventions to accomplish individualized goals within a therapeutic relationship by a credentialed professional, a music therapist uses music and musical activities to support individuals or groups in reaching specific therapeutic goals. This includes activities such as music listening and active music making, which are tailored to participants' cultural context and individual needs.

The FALCO-trial is a parallel 3-arm assessor- and statistician-blinded pragmatic multinational randomized clinical trial. The interventions of interest in the trial (AMG, MLG) are non-pharmacological psychosocial interventions. Both AMG and MLG will be conducted by appropriately qualified music therapists, in groups, with weekly sessions lasting up to 90 minutes. Participants will continue to receive TAU as offered locally.

The primary objective of the study is to determine effects of AMG and MLG versus TAU on addiction severity in people with SUD at one year after randomization.

Вмешательства

  • Поведенческое Active Music Group (AMG)
    Active music group is a music therapy intervention where participants actively make/play music in groups. The sessions will be conducted by an appropriately qualified music therapist.
  • Поведенческое Music Listening Group (MLG)
    Music listening group is a music therapy intervention where participants partake in music listening in groups. The sessions will be conducted by an appropriately qualified music therapist.
  • Поведенческое Treatment as Usual (TAU)
    Treatment as usual as provided locally, which may include pharmacological and/or non-pharmacological interventions (e.g. mindfulness-based intervention, structured physical activity).

Первичные конечные точки

  • Addiction Severity assessed by the the European Addiction Severity Index (EuropASI) [Срок оценки: Baseline, 1 year, 2 years.]
Вторичные конечные точки (12)
  • Recovery assessed by the Substance Use Recovery Evaluator (SURE) [Срок оценки: Baseline, 1 year, 2 years.]
  • Substance use severity assessed by Drug Disorder Identification Test (DUDIT-C) [Срок оценки: Baseline, 3 months, 1 year, 2 years.]
  • Substance use severity assessed by Alcohol Use Disorder Identification Test (AUDIT-C) [Срок оценки: Baseline, 3 months, 1 year, 2 years.]
  • Quality of life assessed by EuroQol (EQ-5D) [Срок оценки: Baseline, 1 year, 2 years.]
  • Depressive symptoms assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) [Срок оценки: Baseline, 1 year, 2 years.]
  • Attrition assessed by clinicians [Срок оценки: 3 Months, 1 year, 2 years.]
  • Adverse effects assessed by clinicians [Срок оценки: 3 months, 1 year, 2 years.]
  • Employment monitored by public records [Срок оценки: 10 years.]
  • Hospitalisation monitored by health records [Срок оценки: 10 years.]
  • Criminal record monitored by public records [Срок оценки: 10 years.]
  • Survival monitored by public records [Срок оценки: 10 years.]
  • Motivation for change assessed by the Importance, Confidence, Readiness Ruler (ICR) [Срок оценки: 1 week, 3 months, 1 year.]

Критерии участия

Критерии включения

  • patients seeking or receiving treatment at the recruitment site for an existing substance use disorder based on ICD-10 criteria
  • ≥18 years old
  • not currently undergoing detoxification (detoxification has been completed or is not currently planned at the time of recruitment)
  • any type of substance use including polysubstance and alcohol use

Критерии исключения

  • exclusively nicotine dependence
  • psychotic episode in the last 3 months
  • insufficient language skills to participate in treatment without the use of a translator
  • hearing impairment that considerably impairs hearing of music played at a moderate volume (not relevant if hearing is sufficiently compensated by a hearing aid)
  • existing diagnosis of dementia
  • is currently receiving music therapy or has received music therapy (i.e. at planned and reoccurring intervals, not counting single random occurrences) during the past year

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Норвегия · 3 центра
  • University of Bergen / NORCE Research AS — Bergen
  • Sykehuset Innlandet — Innlandet
  • Stavanger Universitetssjukehus — Stavanger
Испания · 2 центра
  • Fundacio Sanitaria d'Igualada — Barcelona
  • IDIBGI — Girona
Австрия · 1 центр
  • Anton Proksch Institut — Vienna
Израиль · 1 центр
  • Herzog College — Jerusalem
Италия · 1 центр
  • University of Pavia — Pavia
Palestinian Territories · 1 центр
  • Palestinian National Rehabilitation Centre — Bethlehem
Польша · 1 центр
  • WOTU / University of Gdansk — Gdansk
Швейцария · 1 центр
  • CAD — Zurich

Идентификаторы

NCT: NCT07028983 · 107278 · 101155881 · REF-1131-52304

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗