Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Music Group (AMG), Music Listening Group (MLG), Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Substance Use Disorder (SUD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Israel, Italy, Norway, Palestinian Territories +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fighting Addictions, Improving Lives Through COmprehensive Drug Rehabilitation With Music (FALCO): International Randomised Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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. - Behavioral 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).
Primary outcome measures
- Addiction Severity assessed by the the European Addiction Severity Index (EuropASI) [Time frame: Baseline, 1 year, 2 years.]
Secondary outcome measures (12)
- Recovery assessed by the Substance Use Recovery Evaluator (SURE) [Time frame: Baseline, 1 year, 2 years.]
- Substance use severity assessed by Drug Disorder Identification Test (DUDIT-C) [Time frame: Baseline, 3 months, 1 year, 2 years.]
- Substance use severity assessed by Alcohol Use Disorder Identification Test (AUDIT-C) [Time frame: Baseline, 3 months, 1 year, 2 years.]
- Quality of life assessed by EuroQol (EQ-5D) [Time frame: Baseline, 1 year, 2 years.]
- Depressive symptoms assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: Baseline, 1 year, 2 years.]
- Attrition assessed by clinicians [Time frame: 3 Months, 1 year, 2 years.]
- Adverse effects assessed by clinicians [Time frame: 3 months, 1 year, 2 years.]
- Employment monitored by public records [Time frame: 10 years.]
- Hospitalisation monitored by health records [Time frame: 10 years.]
- Criminal record monitored by public records [Time frame: 10 years.]
- Survival monitored by public records [Time frame: 10 years.]
- Motivation for change assessed by the Importance, Confidence, Readiness Ruler (ICR) [Time frame: 1 week, 3 months, 1 year.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Norway · 3 centers
- University of Bergen / NORCE Research AS — Bergen
- Sykehuset Innlandet — Innlandet
- Stavanger Universitetssjukehus — Stavanger
Spain · 2 centers
- Fundacio Sanitaria d'Igualada — Barcelona
- IDIBGI — Girona
Austria · 1 center
- Anton Proksch Institut — Vienna
Israel · 1 center
- Herzog College — Jerusalem
Italy · 1 center
- University of Pavia — Pavia
Palestinian Territories · 1 center
- Palestinian National Rehabilitation Centre — Bethlehem
Poland · 1 center
- WOTU / University of Gdansk — Gdansk
Switzerland · 1 center
- CAD — Zurich
Identifiers
NCT: NCT07028983 · 107278 · 101155881 · REF-1131-52304