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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
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.
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.
Treatment as usual as provided locally, which may include pharmacological and/or non-pharmacological interventions (e.g. mindfulness-based intervention, structured physical activity).
Anton Proksch Institut
Vienna, Austria
NOT_YET_RECRUITINGHerzog College
Jerusalem, Israel
RECRUITINGUniversity of Pavia
Pavia, Italy
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).
Time frame: Baseline, 1 year, 2 years.
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.
Time frame: Baseline, 1 year, 2 years.
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.
Time frame: Baseline, 3 months, 1 year, 2 years.
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.
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University of Bergen / NORCE Research AS
Bergen, Norway
NOT_YET_RECRUITINGSykehuset Innlandet
Innlandet, Norway
SUSPENDEDStavanger Universitetssjukehus
Stavanger, Norway
SUSPENDEDPalestinian National Rehabilitation Centre
Bethlehem, Palestinian Territories
NOT_YET_RECRUITINGWOTU / University of Gdansk
Gdansk, Poland
RECRUITINGFundacio Sanitaria d'Igualada
Barcelona, Spain
RECRUITINGIDIBGI
Girona, Spain
WITHDRAWN...and 1 more locations
Time frame: Baseline, 3 months, 1 year, 2 years.
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).
Time frame: Baseline, 1 year, 2 years.
Depressive symptoms assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
MADRS is a clinician-administered ten-item interview measuring symptoms of depression. The scale assesses severity of depressive symptoms (rating symptoms on a 7-point scale). Scores range from 0-6, with a maximum score of 60. A higher score indicates more severe depression.
Time frame: Baseline, 1 year, 2 years.
Attrition assessed by clinicians
Clinicians will judge whether a participant is still participating, has decided to withdraw from the study, or contact has been lost. Importantly, participants will not be regarded as withdrawn if they decide to withdraw from interventions or from some assessment procedures.
Time frame: 3 Months, 1 year, 2 years.
Adverse effects assessed by clinicians
We will ask participants to describe any adverse events, and clinicians will then rate whether these were serious or non-serious and related or non-related.
Time frame: 3 months, 1 year, 2 years.
Employment monitored by public records
Patients' participation in the study ends after two years. From public records that are unaffected by loss of contact, employment will be monitored until 10 years after randomisation.
Time frame: 10 years.
Hospitalisation monitored by health records
Patients' participation in the study ends after two years. From electronic health records unaffected by loss of contact, hospitalisation will be monitored until 10 years after randomisation.
Time frame: 10 years.
Criminal record monitored by public records
Patients' participation in the study ends after two years. From public records that are unaffected by loss of contact, criminal record will be monitored until 10 years after randomisation.
Time frame: 10 years.
Survival monitored by public records
Patients' participation in the study ends after two years. From public records that are unaffected by loss of contact, survival will be monitored until 10 years after randomisation.
Time frame: 10 years.
Motivation for change assessed by the Importance, Confidence, Readiness Ruler (ICR)
The ICR is a patient-reported scale that assesses overall motivation to change, including readiness to change. It has 3 items and is rated on a 10-point Likert scale, and total scores range from 0 to 30. Higher scores indicate higher motivation to change.
Time frame: 1 week, 3 months, 1 year.
Craving assessed by the Craving Scale
The Craving Scale is a 3-item patient-reported scale. Scores range from 0-9. High scores indicate higher cravings.
Time frame: Baseline, 1week, 3 months, 1 year.
Social connectedness assessed by the Inclusion of Other in the Self Scale (IOS)
The IOS is a patient-reported single-item visual scale of closeness. scores range from 1-7, with higher score indicating higher social connectedness.
Time frame: 1 week, 3 months, 1 year.
Motivation for change assessed by the University of Rhode Island Change Assessment (URICA)
A more comprehensive patient-reported scale than the brief ICR mentioned above. URICA has 32 items and measures the extent to which individuals identify with different stages of change (precontemplation, contemplation, action, maintenance). Each subscale consists of eight items using 5-point Likert scales ranging from 1 to 5 (resulting in scores ranging from 8 to 40). Subscale scores can be used to trace changes in attitudes related to the specific stages of change. The subscales are combined arithmetically (Contemplation + Action + Maintenance - Precontemplation) to yield a Readiness to Change score, with a possible range of 16-80 and higher scores indicating greater readiness for change.
Time frame: Baseline, 3 months, 1 year.
Anhedonia assessed by the Snaith-Hamilton Pleasure Scale (SHAPS)
SHAPS is a patient-reported scale with 14 items. It measures the capacity to derive pleasure from four different hedonic experiences: interest/pastimes, social interaction, sensory experience and food/drink. Scores range from 0-4. Higher scores represent higher anhedonia level and a lower hedonic tone.
Time frame: Baseline, 3 months, 1 year.
Sleep quality assessed by the Sleep Condition Indicator (SCI)
The SCI has 8 questions covering various sleep aspects such as: sleep onset delay, night-time awakenings, extent of the problem and its effect on daytime activities, mood and relations. Responses are scored from 0 (poor state) to 4 (no/minor problems). A total score of ≤ 16 indicates probable insomnia. Maxmimum score is 32.
Time frame: Baseline, 3 months, 1 year.
Substance use measured by hair samples
Objective measures of substance use will be assessed through hair testing. Three strands of hair as thick as a matchstick will be collected from the occiput as close to the scalp as possible. The 3 cm most proximal to the scalp will be analysed. The levels of substance use will be quantitatively determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) using a protocol deriving the maximum amount of high-quality valid information from the smallest amount of hair.
Time frame: Baseline, 3 months, 1 year.
Brain pathology measured from blood samples
Neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) will be used as potential functional biomarkers of individual substance use burden of the brain. NfL and GFAP analysis: Serum will be collected in silica tubes. After 30min clotting time, the samples will be centrifuged with 1500g for 15min at room temperature. Storage temperature will be -80°C. NfL and GFAP concentrations will be measured in triplicates using simple-plex assays (ProteinSimple, CA, USA) on Ella microfluidic system (BioTechne, MN, USA).
Time frame: Baseline, 3 months, 1 year.
Cognitive function assessed by four tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
The selected CANTAB tasks: 1. Rapid Visual Information Processing (RVP): This task focuses on sustained attention. 2. Spatial Working Memory (SWM): This task mainly assesses visuospatial working memory. 3. Paired Associates Learning (PAL): This task measures visuospatial declarative learning and memory. 4. Intra-Dimensional/Extra-Dimensional Set-Shifting (ID/ED): This test covers rule acquisition and reversal, featuring visual discrimination and attentional set-shifting analogous to the Wisconsin Card Sorting Task.
Time frame: Baseline, 3 months, 1 year.
Social cognition assessed by the video-based online test COgnition of Social Interaction in MOvies (COSIMO)
COSIMO will measure cognitive empathy and mental perspective taking. Performance will be assessed as number of correct answers.
Time frame: Baseline, 3 months, 1 year.
Creativity assessed by a shortened version of the Test of Creative Imagery Abilities (TCIA)
The shortened version of TCIA will be used to measure creative imagery abilities. Participants will be asked to view simple graphite images, generate transformation ideas and draw their favorite idea on paper with no time limit, with the possibility of elaborating or changing the selected image. They will also be asked to write what their drawing represents. The level of creative imagery will be measured by scoring the drawings according to three characteristics: vividness, originality, and transformative ability.
Time frame: Baseline, 3 months, 1 year.
Structural brain scans indicating cognitive impairment
1. Morphometric analysis (MRI-Voxel Based Morphometry, VBM): This analysis permits statistical estimation of whole-brain voxel-level local changes in volume. 2. Cortical folding and cortical thickness: Geometrical representations for the cortical surfaces of each patient will be reconstructed and compared based on 3d/T1-images. 3. Diffusion Tensor Imaging (MRI-DTI) analysis: DTI will provide precise indices related to tissue white-matter integrity and microstructure reorganization. 4. DRI fiber tracking: Tracking and reconstruction of white-matter tracks allow to study the larger scale patterns of connectivity and differences in the major association paths in the brain.
Time frame: Baseline, 3 months, 1 year.