Clinical trial NCT05180617: Feasibility of Music Therapy in Community Substance Misuse Treatment Services
Official title: Feasibility of Music Therapy, Neural Processing and Reduction of Craving in Community Substance Misuse Treatment Services (CSMTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Addiction
Craving
music therapy
mental health
neural dynamics
EEG
Feasibility
emotion processing
drug memory
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: Westminster Drug Project
First posted: 2022-01-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Service users in structured treatment for drug and/or alcohol misuse,
* Aged 18-65
* Reporting / Self-reporting symptoms of depression and/or anxiety.
* Service users will need to be deemed suitable to take part in a group / individual setting by their key workers.
* Right-handedness

Exclusion Criteria:

* Service users on medication for depression or anxiety,
* Services users who are currently receiving treatment as part of a Drug Rehabilitation Requirement (DRR) or Alcohol Treatment Requirement (ATR).
* Service users who are unable to provide informed consent due to a lack of mental capacity,
* Service users with little/no understanding of spoken English.
* Service users with a brain injury or history of epilepsy.
* Left-Handedness
* Mixed-Handedness
* Not registered with a General Practitioner (GP) / unable to provide GP details

Primary outcomes:
measure: Retention in Treatment 1 (Attendance Sheet)
timeFrame: up to 6 weeks
measure: Acceptability of Treatment 1 (Participant Satisfaction Survey)
timeFrame: Post-Intervention Measure: at week 8
measure: Acceptability of treatment 2 (Focus Groups)
timeFrame: Post-Intervention Measure: at week 9
measure: Retention in Treatment 2 (Treatment Status)
timeFrame: 1-month post-intervention: at week 11
Secondary outcomes:
measure: The Brief Substance Craving Scale (BSCS)
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: Craving Thermometer VAS
timeFrame: up to 6 weeks
measure: The Treatment Outcome Profile (TOP)
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: The Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: Resting-state EEG frontal alpha asymmetry (FAA)
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: Resting-state EEG frontal midline theta (FMT)
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: Resting-state EEG beta frequency band
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: Go/No-Go Event-Related Potentials (ERPs) task
timeFrame: At baseline (week 1) and end of treatment (week 8)
measure: EEG Hyperscanning
timeFrame: At week 3 and week 6
measure: Dual EEG resting-state Frontal Alpha Asymmetry
timeFrame: At week 3 and week 6
measure: Dual EEG resting-state Frontal Midline Theta
timeFrame: At week 3 and week 6
measure: Dual EEG resting-state Beta waves
timeFrame: At week 3 and week 6
measure: Semi-structured interview
timeFrame: At week 3 and week 6
measure: Helping Alliance Questionnaire - II (HAQ-II)
timeFrame: At week 3 and week 6
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Westminster Drug project
Study officials:
affiliation: WDP
name: Daniel Murtagh
role: PRINCIPAL_INVESTIGATOR
affiliation: Anglia Ruskin University
name: Jorg C Fachner, PhD
role: STUDY_DIRECTOR
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