Feasibility of Music Therapy in Community Substance Misuse Treatment Services
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Music Therapy (MT) has been shown to improve several symptoms experienced by people with
      Substance Use Disorder (SUD), such as depressive and anxiety symptoms, as well as negative
      emotions. Particularly, a recent Cochrane review reported craving reduction as a main outcome
      for MT delivered to SUD participants. The possible mechanism(s) of therapeutic change is yet
      to be identified and future randomized control trials applying neuroscience research methods
      may help doing so. However, there is a significant lack of studies investigating those
      effects in a specific cohort of out-patients on prescription medicine from Community
      Substance Misuse Treatment Services (CSMTS). This research project aims to evaluate the
      acceptability and feasibility of MT and the applied test battery in CSMTS for a future
      Randomised Controlled Trails (RCT).

      Fifteen participants from a CSMTS will take part in a three-arm randomized non-blind
      controlled trial. 5 participants will receive 6 weekly individual music therapy sessions
      (IMT), 5 participants will receive 6 weekly group music therapy (GMT) sessions and 5
      participants will act as a control group (CG) receiving treatment as usual (TAU). IMT and GMT
      participants will continue to receive TAU by the CSMTS. The CG will have the opportunity to
      receive MT as well, after the end of the study.

      Regarding the feasibility of the service implementation, the investigators will evaluate
      participant satisfaction and implement a focus group following the final session to collect
      feedback and evaluation on acceptability of the intervention from both participants and
      staff. Moreover, retention in treatment and completion rates will be measured after the end
      of the MT sessions.

      Furthermore, based on previous research and the theoretical basis of MT interventions, the
      investigators aim to explore the effects of MT on craving, substance use, symptoms of
      depression and anxiety, and inhibitory control in people with SUD. Changes in the brain
      correlates of the abovementioned symptoms will be investigated as well as how music and
      emotion are processed in the brain during MT. The investigators will collect subjective and
      objective baseline measurements and compare them against post-treatment measurements. Some
      variables of interest will be measured by Electroencephalography (EEG) which is a
      non-invasive technique to record electrical brain activity.

      The study will take place in a Westminster Drug Project provided community-based integrated
      adult substance misuse service in London. Participants will be recruited from service users
      receiving treatment at this service.
    

Detailed description: 
      This feasibility research project seeks to support individuals receiving treatment from a
      Community Substance Misuse Treatment Service (CSMTS) in reducing symptoms of craving,
      anxiety, depression and negative emotion through either group or individual music therapy
      sessions.

      To test the feasibility of the implementation into CSMTS and the application of a test
      battery including self-report, interviews and physiological measures, a total of 15 adult
      participants will be randomly allocated to three arms of the study. The participants will
      receive either Group Music Therapy (GMT) alongside Standard Treatment (ST), Individual Music
      Therapy (IMT) alongside Standard Treatment or Standard Treatment only. Music therapy (MT)
      sessions will provide an opportunity for participants to interact musically with the music
      therapist using acoustic and electronic instruments. During the study, participants will be
      asked to complete questionnaires and behavioural measures and participate in
      electroencephalography recordings.

      For SUD participants, the duration of their direct involvement with the research will be 9
      weeks. Additional data will be gathered by the research team at 1 month post-intervention:
      this will not require participant involvement as this data will be captured from the
      Westminster Drug Project's (WDP) patient database.

      Prior to and following the research intervention, participants have been (and will be)
      consulted and given the opportunity to provide feedback on the research design. Where
      appropriate, changes were made to the research procedures to reflect this feedback.

      Propositions.

      Previous studies found therapeutic effects of MT on several substance misuse - related
      outcomes such as depressive symptoms, anxiety, negative emotions (i.e. anger) and subjective
      feeling of craving. However, there's a lack of studies investigating and adding explanatory
      value to these outcomes in CSMTS.

      Based on previous research and the theoretical basis of MT interventions, the investigators
      aim to explore the effects of MT in addition to ST versus ST alone.

      The investigators propose that this MT intervention will a) be feasible and acceptable for
      individuals receiving community-based substance misuse treatment, b) lead to a decrease in
      symptoms of anxiety, depression and craving; c) improve treatment outcomes for those in
      community substance misuse treatment services; d) improve inhibitory control, potentially
      correlating with changes in craving state.

      Furthermore, the investigators will explore the feasibility of measuring neural correlates of
      moments of therapeutic interest regarding craving, strong emotion and therapeutic
      relationship during IMT sessions with EEG Hyperscanning and audio-visual monitoring in
      sessions 2 and 5. The investigators expect moments of strong emotion and increased
      therapeutic relationship to occur more often in the later session. The investigators will
      record and analyse participants' engagement with electronic music production instruments
      (EMPI) and acoustic instruments. Hyperscanning, and high-quality session recordings will
      allow analysing continuous data of contextualised events and moments of therapeutic interest
      during IMT.

      Research methodology.

      To approach these propositions the research team has identified that a feasibility/pilot
      study employing three study arms would be most appropriate. The study will involve the
      recruitment of 15 adult participants receiving treatment for substance misuse and are
      experiencing self-reported symptoms of depression/anxiety.

      The study is designed as a three-armed study with group 1 receiving 6 weekly sessions of
      Group Music Therapy (GMT) and ST, group 2 receiving 6 weekly sessions of Individual Music
      Therapy (IMT) and ST and group 3, which is a control group (CG), receiving 6 weeks of ST
      only.

      In addition to a post intervention focus group session with MT participants, the
      investigators will recruit a Staff Group (SG) of 4-8 WDP staff who will participate in a
      focus group after both sets of MT have been delivered. The staff focus group will explore the
      feasibility of MT from a number of perspectives, including those involved in the set-up of
      the MT sessions.

      Research duration.

      The duration of this research is outlined to be a period of 6 months. Participants will be
      committing to attend 6 weekly music therapy sessions, a focus group (consisting of
      participants from IMT and GMT) to gather participant's feedback on feasibility and
      accessibility, and only for GMT participants, an individual debriefing interview with the
      therapist.

      In addition to this, those considering participating will have an opportunity, prior to
      volunteering, to meet with the research team and take part in a workshop where the research
      team will describe and demonstrate the process of MT, providing an opportunity for potential
      participants to ask questions and provide feedback. This introductory session will be in
      addition to the 8-week commitment the investigators are seeking from participants.

      While participants will be committing for 8 weeks, the research team will carry out further
      investigations at week 11 (1 month post intervention).

      Recruitment.

      Recruitment will be carried out by advertising the project in the service and by WDP staff
      identifying eligible service users through WDP's case management system. Service users will
      be asked by their keyworker to provide the information sheets and informed consent form. For
      those that have not been identified through the case management system but approached by
      their keyworker, the keyworker or service admin will ascertain eligibility through the case
      management system and in the keyworker session. If eligible, the information sheets and
      informed consent form will be handed out.

      The research team has already consulted with 7 service users, presented the design and
      received positive feedback on the current design. The research team will seek further input
      from service users through WDP's service user consultation process and hold a presentation of
      the research project within the service to interested service users. This presentation will
      seek to aid recruitment and provide further information about the project and what
      participation will involve as well as give interested service users a chance to ask the
      research team questions.

      Those service users who are interested in being considered for the study will be asked to
      complete the consent form and hand this to either their key-worker or a member of WDP's
      Innovation and Research research team.

      Upon their recruitment, each of the 15 participants will be assigned a unique, randomly
      generated number to anonymise their personal information.

      The investigators will also recruit up to 8 WDP staff members, who were involved in the
      implementation of the intervention, to a single focus group after the music therapy
      intervention is complete. The Staff group (SG) will not receive music therapy.

      Research Procedure.

      Following recruitment, participants will be randomly allocated to one of the three research
      groups: group 1 receiving GMT and ST, group 2 receiving IMT and ST and group 3 receiving ST
      only.

      The planned schedule will be:

      Week 1: GMT, IMT and CG baseline (pre-intervention) measures at time point 1 (TP1).

      Weeks 2-7: GMT and IMT receive 6 weekly MT sessions plus ST; GMT and IMT pre-post session
      measures; CG receives ST only; IMT only: EEG Hyperscanning during Session 2 (week 3) and
      session 5 (week 6) and post session interview and questionnaire

      Week 8: GMT, IMT and CG post-intervention measures and participant satisfaction survey at
      time point 2 (TP2)

      Week 9: Feasibility Focus groups for SG, GMT and IMT; Individual debriefing interview with
      therapist for GMT participants only

      Week 11: (1 months post intervention): all groups (excluding staff group) will have retention
      in treatment, treatment engagement and completion rate taken from WDP's Case management
      system
    

Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Intervention description(s): Music therapy participants will interact both musically and verbally with the therapist and will be given a range of both electronic and acoustic instruments to choose from. Music therapy sessions will be based upon music improvisation, and as such participants are not required to have any previous instrument or other music experience and be invited to improvise freely using the instruments. The music therapist will accompany participants in the improvisation. This provides participants with an opportunity to connect with emotions and feelings connected to hidden psychic material. Following improvisations, the therapist and client will identify these moments of interest which can be further explored either verbally or through further improvisation. The music created within sessions will be recorded and participants can take a copy of the recordings home and it will be used in the therapeutic monitoring and analysis of sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Addiction; Craving; music therapy; mental health; neural dynamics; EEG; Feasibility; emotion processing; drug memory