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.
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
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)
Parallel
Active Music Group (AMG)
BehavioralActive 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.
Music Listening Group (MLG)
BehavioralMusic 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.
Treatment as Usual (TAU)
BehavioralTreatment as usual as provided locally, which may include pharmacological and/or non-pharmacological interventions (e.g. mindfulness-based intervention, structured physical activity).
Addiction Severity assessed by the the European Addiction Severity Index (EuropASI)
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).
Recovery assessed by the Substance Use Recovery Evaluator (SURE)
The scale captures five factors (substance use, material resources, outlook on life, self-care, relationships) using 21 items. Each question scores between 1-3. Total score ranges between 21-63, with a higher score indicating better recovery. The scale is patient-reported and was developed with strong user involvement.
Substance use severity assessed by Drug Disorder Identification Test (DUDIT-C)
This scale is a patient-reported short screening tool that can be used repeatedly. It consists of 11 questions, including 9 ranging from 0-4 and 2 from 0-2, producing a DUDIT sum score of 0-40. In addition, a DUDIT-C sum score of the first 4 items can range from 0-16. Higher scores indicate higher substance use severity. A score of 0 indicates self-reported abstinence, scores ≥ 7 indicate heavy use.
Substance use severity assessed by Alcohol Use Disorder Identification Test (AUDIT-C)
This scale is a patient-reported short screening tool that can be used repeatedly. It consists of 10 questions, each ranging from 0-4, producing an AUDIT sum score of 0-40. In addition, an AUDIT-C sum score of the first 3 items can range from 0-12. Higher scores indicate higher substance use severity. A score of 0 indicates self-reported alcohol abstinence, scores ≥ 3/4 (women/men) indicate alcohol misuse.
Quality of life assessed by EuroQol (EQ-5D)
EQ-5D is a patient-reported scale with 5 items plus a visual analogue scale (VAS). The 5-item scale ranges from "less than 0" (worse than death; depending on country-specific weights) to 1 (best). The VAS provides a global one-item rating of current perceived health ranging from 0 (worst possible) to 100 (best possible health).
Click on the lead sponsor to view all of their trials.
NORCE Norwegian Research Centre AS
Lead sponsor
University of Bergen
Collaborator
Helse Stavanger HF
Collaborator
Sykehuset Innlandet HF
Collaborator
University of Vienna
Collaborator
Anton Proksch Institut
Collaborator
University of Music and Performing Arts, Vienna
Collaborator
Austrian Institute for Health Technology Assessment GmbH
Collaborator
Herzog College
Collaborator
Bar-Ilan University, Israel
Collaborator
University of Pavia
Collaborator
University of Gdańsk
Collaborator
Wojewódzki Ośrodek Terapii Uzależnień w Gdańsku
Collaborator
Institut d'Investigació Biomèdica de Bellvitge
Collaborator
Institució Catalana de Recerca i Estudis Avançats
Collaborator
Universitat de Girona
Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborator
Fundació Sanitària d'Igualada
Collaborator
University of Zurich
Collaborator