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                                          • FALCO: Fighting Addictions, improving Lives: COmprehensive drug rehabilitation with music

                                          FALCO: Fighting Addictions, improving Lives: COmprehensive drug rehabilitation with music

                                          Adobestock-10051843-curaphotography
                                          Research area: Psychological & psychiatric interventions

                                          Project leaders: Ingrid Zechmeister-Koss

                                          Project team: Lucia Gassner

                                          Authors: Gassner L1, Bidzan-Bluma I2, Makurat D2, Karshikofffrom B3, Magel F4, Svensden TS5, Bieleninik L2, Erga AH3, Zechmeister-Koss I1

                                          Affiliations: 1Austrian Institute for Health Technology Assessment GmbH, Austria; 2University of Gdansk, Poland; 3University of Stavanger, Norway; 4Anton Proksch Institute, Austria; 5Regional Center for Substance Use Research, Norway

                                          Research area: Psychological & psychiatric interventions
                                          Project leader: Ingrid Zechmeister-Koss
                                          Principal investigator: Catherine Lourdes Dy (NORCE Norwegian Research Centre AS)
                                          Further project partners: NORCE Norwegian Research Centre AS (NO, coordinator), Universitetet I Bergen (NO), Helse Stavanger HF (NO), Sykehuset Innlandet HF (NO), Universität Wien (AT), Stiftung Anton Proksch Institut Wien (AT), Universität für Musik und darstellende Kunst Wien (AT), HAT Austria – Austrian Institute for Health Technology Assessment GmbH (AT), Herzog College (IL), Bar Ilan University (IL), Universita Degli Studi Di Pavia (IT), Uniwersytet Gdanski (PL), Fundacio Institut d’Investigacio Biomedica de Bellvitge (ES), Universitat de Girona (ES), Fundacio Institut d’Investigacio Biomedica de Girona Doctor Josep Trueta (ES), Fundació Sanitària d’Igualda (ES), Universität Zürich (CH)

                                          This AIHTA third-party funding is part of a Horizon-Europe project (grant number 101155881)

                                          Duration: January 2025 to December 2029
                                          Language: English

                                          1. Deliverable:

                                          Music therapy: Clinical and socioeconomic outcome parameters and long-term measuring instruments in individuals with substance use disorders. A systematic review

                                          Background
                                          Substance use disorder (SUD) is associated with a high global burden of disease, with 1.3% of all disability-adjusted life years lost due to illicit drugs and 4.2% due to alcohol [1]. There are 1 million high-risk opioid users in the European Union [2]. Multimorbidity is highly prevalent and includes polysubstance use, co-occurring mental health conditions, and various sequelae which could be prevented by more effective SUD treatment, including infectious and non-communicable diseases [1]. SUD is also related to crime and poverty through multiple bidirectional links, which increases the societal importance of improving rehabilitation in SUD [1]. Many patients drop out or do not benefit from existing non-pharmacological and pharmacological interventions [3].

                                          Music can engage the brain’s reward system similarly to addictive substances [4-6]. It is also rated as one of the most intrinsically rewarding activities [7]. Therefore, music can provide an effective and affordable addition to reduce SUD [8]. Due to the high level of relapses in the first year after the treatment, an evaluation of substance use patterns in the second year following treatment is needed [8]. Longer lengths of substance use treatment are associated with lower levels of substance use at long-term follow-ups and better engagement in aftercare programmes [9, 10]. More extended periods of music interventions would likely be required to impact substance use behaviours at long-term follow-ups. Thus, it is crucial to investigate the impact of MT on retention in treatment over more extended periods and evaluate the long-term impacts of MT for people with SUDs [8]. For that purpose, a systematic review will be carried out to identify appropriate long-term (>1 year) outcome measures and tools. In order to better understand which outcomes might be most relevant for patients, we will conduct interviews with SUD patients. This shared understanding of perspectives will ultimately aid in understanding patient-relevant measuring instruments.

                                          Aims of the report
                                          The report aims to give an overview of clinical (e.g. addiction severity, recovery, substance use, craving) and socioeconomic (i.e. payer-relevant criteria such as integration to work life, unemployment days, health service use, retention in treatment) outcome parameters and types of (serious) adverse events identified in the existing evidence (of music therapy) in people with SUD (RQ1), how these outcomes are measured, and which characteristics do those instruments have (RQ2).

                                          As research on the long-term outcomes of (long-term) MT treatment is lacking, next to our results of the systematic review (i.e. RQ1+2), fact sheets will give an overview of which measuring instruments are appropriate, feasible and user-relevant, especially for long-term measures (RQ3). Additional interviews with SUD service users in two partnering countries, Norway and Poland, will give insights into SUD service user’s perspectives. The main question of the interviews is whether these service user inputs correspond to the outcomes/instruments from the review's prior research questions. In Austria, we aim to collect the perspectives of three service users. These perspectives will help us understand service-user-relevant measuring instruments for further work packages for the FALCO project.

                                          Research questions (RQs)

                                          RQ1: Which clinical and socioeconomic outcome parameters and types of (serious) adverse events can be identified in the existing evidence (of music therapy) in people with SUD? (à review of relevant clinical and socioeconomic outcome parameters and types of (serious) adverse events)

                                          RQ2: How are these clinical and socioeconomic outcome parameters and types of (serious) adverse events measured, and what are the characteristics of those instruments? (à review of measuring instruments and their characteristics)

                                          RQ3: Which measuring instruments are appropriate, feasible and user-relevant, especially for long-term measures in patients with SUDs? (à fact sheets of long-term measuring instruments)

                                          Methods RQ1 & RQ2

                                          • Systematic literature search of clinical music therapy studies (only reviews)
                                          • Databases: The Cochrane Library, Centre for Reviews and Dissemination (CRD) database, Embase, MEDLINE, PsycINFO, Web of Science
                                          • Manual search and brief survey in selected countries (AUT, NOR, POL) regarding additional instruments measuring socioeconomic criteria; possible sources: websites of SUD rehabilitation centres, institutions evaluating SUD rehabilitation centres, healthcare system payers (insurances), general search in Google and Google Scholar (e.g. evaluation reports, project reports, validation reports)
                                          • If applicable: manual search in non-MT areas (patients with SUDs) à which additional socioeconomic instruments can be found?
                                          • Creating a table of relevant clinical and socioeconomic outcome parameters and types of (serious) adverse events
                                          • Creating a table of measuring instruments and their characteristics (deliverable 1)
                                          • No risk of bias assessment (e.g. AMSTAR - Assessing the Methodological Quality of Systematic Reviews) since the focus is on the outcome parameters and measuring instruments and not on the effectiveness/efficacy of music therapy

                                          PICO for RQ1 & RQ2

                                          Population

                                          Inclusion criteria:

                                          • patients seeking or receiving treatment at the recruitment site for an existing substance use disorder (SUD) 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 regular music therapy (i.e. at planned and reoccurring intervals, not counting single random occurrences) during the past year

                                          Intervention

                                          Active music groups (AMG) and music listening groups (MLG)

                                          Control

                                          -

                                          Outcomes

                                          RQ1: Clinical and socioeconomic outcomes parameters [1] and types of (serious) adverse events (e.g. relapse requiring hospitalisation, suicide (attempts))

                                          RQ2: Measuring instruments and their characteristics

                                          General characteristics:

                                          • Short description, method
                                          • Validity/reliability
                                          • Target group, (primary) diagnosis of patients
                                          • Test points
                                          • Languages, validated/quality-checked translation
                                          • Intervention evaluated (active music groups or music listening groups)
                                          • Setting of assessment (e.g. outpatient/inpatient treatment)

                                          Application characteristics:

                                          • How many items
                                          • Testing time (min)
                                          • Administrative effort
                                          • Documentation (e.g. pen-paper, iPad)
                                          • Who assesses (e.g. self-, clinician-, performance reported)
                                          • Free or licenced instrument

                                          Study design

                                          Reviews

                                          Publication
                                          period

                                          From inception to 2024

                                          Databases

                                          The Cochrane Library, Centre for Reviews and Dissemination (CRD) database, Embase, MEDLINE, PsycINFO, Web of Science

                                          Languages

                                          All

                                          Methods RQ3

                                          • Presentation of a long and short list of measuring instruments (from prior RQs) to the FALCO partners
                                          • Prioritisation of a short list of measuring instruments among FALCO partners à Are the selected instruments appropriate for long-term (>1 year) measurements?
                                          • Manual search for specific measuring instruments from the shortlist: appropriate for long-term measures, languages, validation (validity/accuracy/reliability literature), minimum important difference, pros & cons etc.
                                          • If applicable: search for measuring instruments for non-SUD à transferability to SUD?
                                          • Creating fact sheets of the most appropriate, feasible and user-relevant long-term measuring instruments

                                          Service user involvement

                                          In the frame of the systematic review, interviews with people with lived experience are planned in three countries (Austria, Norway, Poland). Professional knowledge cannot replace the lived experiences of people with SUDs, as the service users are the key actors contributing to the project. In this report, service user involvement should achieve knowledge that would otherwise not be produced and should help uncover, e.g., restrictions or suffering due to SUD or aspects that should improve due to MT. We aim to explore with people with lived experience their understanding of patient-relevant outcomes and consequently measuring instruments.

                                          The service users might have additional physical illnesses, disabilities or mental illnesses and are a vulnerable group. Therefore, the interviews take place at the Anton Proksch Institute, where psychotherapists, clinical/health psychologists, or social workers can protect and inform the participants.

                                          Methods

                                          • Creating a semi-structured interview guide for the service user involvement among input from FALCO partners
                                          • Creating participant information sheet and consent form
                                          • Ethical approval
                                          • Service user acquisition in Austria, Norway, and Poland
                                          • Interviews will be conducted in a clinical setting (outpatient clinic, daycare centre or other hospital setting)
                                          • The interviewees should be in therapy with at least one year of sobriety but not in music therapy
                                          • Recruitment in Austria within the outpatient clinic by their practitioners (doctors, psychotherapists, clinical and health psychologists, social workers) at the Anton Proksch Institute, Vienna
                                          • Doing face-to-face interviews with three service users at each site, which are audio-recorded using a smartphone voice recorder
                                          • Transcribing using e.g. Good Tape, Trint or Word 365 and translating interviews
                                          • Analysing and interpreting interviews with the qualitative content analysis using e.g. MAXQDA
                                          • Summarising nine service user interviews

                                          Interview guideline

                                          Time before starting a therapy

                                          • How did problematic substance use affect your life before you decided to go into treatment?
                                          • How did your problematic substance use affect your surroundings?
                                          • What aspects of your mental health have been most affected by problematic substance use?
                                          • What were the effects of problematic substance use on

                                          a) familial relationships,

                                          b) social stigma,

                                          c) job situation,

                                          d) financial stress, and

                                          e) other socio-economical aspects?

                                          • How do you think participating in music therapy might influence your ability to return to work or maintain a stable daily routine?
                                          • What were your own efforts when managing to quit problematic substance use?
                                          • What role(s) does music play in your life?

                                          While therapy

                                          • Why did you decide to quit substance use?
                                          • Can you tell me about your experiences with substance use treatments/ follow-up services? What were the most helpful and the most challenging aspects of these experiences? How has the period without using substances affected your life?

                                          Long-term aspects

                                          • What have the most important aspects been for you to stay abstinent over time?
                                          • Has your social life changed over time? How?
                                          • Has your position in society changed over time? How?

                                          Others

                                          • Is there anything else you think would be helpful for researchers and/or policymakers to know about how comprehensive changes can happen in people's lives?
                                          • Do these service user inputs correspond to the outcomes/instruments from RQ1 & RQ2? (service user relevant instruments)

                                          Workflows are organised according to the principle of dual control; the results are subject to internal and external reviewers.

                                          References:
                                          [1]  GBD Alcohol and Drug Use Collaborators. The global burden of disease attributable to alcohol and drug use in 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Psychiatry. 2018;5(12):987-1012. Epub 20181101. DOI: 10.1016/S2215-0366(18)30337-7.
                                          [2]  European Monitoring Centre for Drugs and Drug Addiction. European Drug Report 2022: Trends and Developments. Luxemburg: Publications Office of the European Union, 2022.
                                          [3]  Svendsen T., Veseth M., McKay J., Bjornestad J., Erga A., Moltu C., et al. Securing Participant Engagement in Longitudinal Substance Use Disorder Recovery Research: A Qualitative Exploration of Key Retention Factors. J Psychosoc Rehabil Ment Health. 2021;8:247–259.
                                          [4]  Ferreri L., Mas-Herrero E., Cardona G., Zatorre R. J., Antonijoan R. M., Valle M., et al. Dopamine modulations of reward-driven music memory consolidation. Ann N Y Acad Sci. 2021;1502(1):85-98. Epub 20210711. DOI: 10.1111/nyas.14656.
                                          [5]  Mas-Herrero E., Marco-Pallares J., Lorenzo-Seva U., Zatorre R. and Rodriguez-Fornells A. Individual Differences in Music Reward Experiences. Music Perception. 2013;31:118–138.
                                          [6]  Koelsch S. A coordinate-based meta-analysis of music-evoked emotions. Neuroimage. 2020;223:117350. Epub 20200906. DOI: 10.1016/j.neuroimage.2020.117350.
                                          [7]  Dube L. and Le Bel J. The content and structure of laypeople's concept of pleasure. Cogn Emot. 2003;17(2):263-295. DOI: 10.1080/02699930302295.
                                          [8]  Ghetti C., Chen X. J., Brenner A. K., Hakvoort L. G., Lien L., Fachner J., et al. Music therapy for people with substance use disorders. Cochrane Database Syst Rev. 2022;5(5):CD012576. Epub 20220509. DOI: 10.1002/14651858.CD012576.pub3.
                                          [9]   Arbour S., Hambley J. and Ho V. Predictors and outcome of aftercare participation of alcohol and drug users completing residential treatment. Subst Use Misuse. 2011;46(10):1275-1287. Epub 20110526. DOI: 10.3109/10826084.2011.572941.
                                          [10]  Moos R. H. and Moos B. S. Treated and untreated alcohol-use disorders: course and predictors of remission and relapse. Eval Rev. 2007;31(6):564-584. DOI: 10.1177/0193841X07306749.


                                          [1] Predefined questionnaires from proposal:

                                          • Addiction severity: Anxiety Sensitivity Index (ASI)
                                          • Recovery: Substance Use Recovery Evaluator (SURE)
                                          • Alcohol/substance use: Drug Use Identification Test (DUDIT), Alcohol Use Disorders Identification Test (AUDIT)
                                          • Quality of life: EuroQoL-5D (EQ-5D)
                                          • Psychological symptoms: Montgomery-Åsberg Depression Rating Scale (MADRS), Beck's Depression Inventory (BDI)

                                          Additional tools, e.g. from [8]

                                          • Addiction severity: Drinking Inventory Consequences (DrinkC), Severity of Dependence Scale (SDS)
                                          • Alcohol/substance use: amount, frequency, peak use (as measured by self-report, reported by independent evaluators, urine analysis, blood samples)
                                          • Psychological symptoms: Hamilton Rating Scale for Depression (HRSD), State-Trait Anxiety Inventory (STAI), visual or analogue scales
                                          • Substance craving: Brief Substance Craving Scale (BSCS)
                                          • Motivation for treatment/change: Readiness to Change Questionnaire (RTCQ), Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), University of Thode Island Change Assessment Scale (URICA), visual or analogue scales
                                          • Motivation to stay sober/clean: Commitment to Sobriety Scale (CSS), visual or analogue scales
                                          • Retention in treatment (as measured by the number of participants remaining in treatment at the end of the study)
                                          • Capacity for emotion regulation: Stroop test
                                          • Service use: Client Service Receipt Inventory (CSRI)

                                           

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