Fighting Addictions, Improving Lives Through COmprehensive Drug Rehabilitation With Music (FALCO): International Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 19
- 主要终点
- Addiction Severity assessed by the the European Addiction Severity Index (EuropASI)
研究概览
简要总结
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.
详细描述
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.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The primary outcome and all other clinician-based measures will be conducted by masked assessors. Masking success will be verified by asking the assessor at the end of the primary endpoint assessment if they inadvertently found out the participant's allocation, and if so, to state the condition they believe the participant was allocated to. Statisticians conducting analyses will also be masked, and report writing will be masked until a draft is ready.
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
- •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
排除标准
- •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
研究组 & 干预措施
Music Listening Group(MLG) + Treatment as Usual(TAU)
Participants will partake in a music listening group, as well as undergo treatment as usual as offered locally.
干预措施: Music Listening Group (MLG) (Behavioral)
Active Music Group(AMG) + Treatment as Usual(TAU)
Participants will partake in an active music group, as well as undergo treatment as usual as offered locally.
干预措施: Active Music Group (AMG) (Behavioral)
Treatment as Usual (TAU)
Treatment as usual, as offered locally and not facilitated by the study.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Addiction Severity assessed by the the European Addiction Severity Index (EuropASI)
时间窗: Baseline, 1 year, 2 years.
The survey covers a broad concept of addiction, including changes that typically require a long time, across seven domains (general medical condition, professional and financial situation, substance use, other drug consumption, legal problems, family and social relations, psychological condition). It has been adapted specifically for use in European contexts. The scale is clinician-based and includes 164 items, with a fine-grained Composite score of 0 (best) to 1 (worst).
次要结局
- Recovery assessed by the Substance Use Recovery Evaluator (SURE)(Baseline, 1 year, 2 years.)
- Substance use severity assessed by Drug Disorder Identification Test (DUDIT-C)(Baseline, 3 months, 1 year, 2 years.)
- Substance use severity assessed by Alcohol Use Disorder Identification Test (AUDIT-C)(Baseline, 3 months, 1 year, 2 years.)
- Quality of life assessed by EuroQol (EQ-5D)(Baseline, 1 year, 2 years.)
- Depressive symptoms assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline, 1 year, 2 years.)
- Attrition assessed by clinicians(3 Months, 1 year, 2 years.)
- Adverse effects assessed by clinicians(3 months, 1 year, 2 years.)
- Employment monitored by public records(10 years.)
- Hospitalisation monitored by health records(10 years.)
- Criminal record monitored by public records(10 years.)
- Survival monitored by public records(10 years.)
- Motivation for change assessed by the Importance, Confidence, Readiness Ruler (ICR)(1 week, 3 months, 1 year.)
- Craving assessed by the Craving Scale(Baseline, 1week, 3 months, 1 year.)
- Social connectedness assessed by the Inclusion of Other in the Self Scale (IOS)(1 week, 3 months, 1 year.)
- Motivation for change assessed by the University of Rhode Island Change Assessment (URICA)(Baseline, 3 months, 1 year.)
- Anhedonia assessed by the Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline, 3 months, 1 year.)
- Sleep quality assessed by the Sleep Condition Indicator (SCI)(Baseline, 3 months, 1 year.)
- Substance use measured by hair samples(Baseline, 3 months, 1 year.)
- Brain pathology measured from blood samples(Baseline, 3 months, 1 year.)
- Cognitive function assessed by four tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline, 3 months, 1 year.)
- Social cognition assessed by the video-based online test COgnition of Social Interaction in MOvies (COSIMO)(Baseline, 3 months, 1 year.)
- Creativity assessed by a shortened version of the Test of Creative Imagery Abilities (TCIA)(Baseline, 3 months, 1 year.)
- Structural brain scans indicating cognitive impairment(Baseline, 3 months, 1 year.)