Feasibility of Music Therapy, Neural Processing and Reduction of Craving in Community Substance Misuse Treatment Services (CSMTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Retention in Treatment 1 (Attendance Sheet)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Retention in Treatment 1 (Attendance Sheet)
时间窗: up to 6 weeks
Retention in treatment will be assessed through an attendance sheet to be completed by the music therapist and the participants receiving Group Music Therapy (GMT) and Individual Music Therapy (IMT) after each session (6 sessions). In this way, participants' feedback will be taken throughout the treatment process.
Acceptability of Treatment 1 (Participant Satisfaction Survey)
时间窗: Post-Intervention Measure: at week 8
Regarding the feasibility of the service implementation, the investigators will evaluate participant satisfaction and implement a focus group following the final session to collect both participants and staff feedback and evaluation. A Participant Satisfaction Survey will be conducted at week 8 (end of treatment) to the 10 participants receiving group music therapy (GMT) and individual music therapy (IMT).
Acceptability of treatment 2 (Focus Groups)
时间窗: Post-Intervention Measure: at week 9
Regarding the feasibility of the service implementation, the investigators will evaluate participant satisfaction and implement a focus group following the final session to collect both participants and staff feedback and evaluation. FOCUS GROUPS (FG). The feasibility of the music therapy intervention will be assessed with FG after the intervention. FG 1 will consist of individual and group music therapy members ; FG 2 will consist of 4 WDP service staff members attending a single focus group to explore staff perspectives on MT.
Retention in Treatment 2 (Treatment Status)
时间窗: 1-month post-intervention: at week 11
The treatment status from participants receiving Individual Music Therapy (IMT), Group Music Therapy (GMT) and Standard Treatment (ST) will be collected by WDP's case management system and will provide information about retention in treatment, treatment engagement and completion rate taken from WDP's Case management system
次要结局
- The Brief Substance Craving Scale (BSCS)(At baseline (week 1) and end of treatment (week 8))
- Dual EEG resting-state Beta waves(At week 3 and week 6)
- Semi-structured interview(At week 3 and week 6)
- Go/No-Go Event-Related Potentials (ERPs) task(At baseline (week 1) and end of treatment (week 8))
- Dual EEG resting-state Frontal Alpha Asymmetry(At week 3 and week 6)
- Helping Alliance Questionnaire - II (HAQ-II)(At week 3 and week 6)
- Resting-state EEG frontal alpha asymmetry (FAA)(At baseline (week 1) and end of treatment (week 8))
- Resting-state EEG frontal midline theta (FMT)(At baseline (week 1) and end of treatment (week 8))
- Resting-state EEG beta frequency band(At baseline (week 1) and end of treatment (week 8))
- EEG Hyperscanning(At week 3 and week 6)
- The Patient Health Questionnaire (PHQ-9)(At baseline (week 1) and end of treatment (week 8))
- The Generalised Anxiety Disorder Assessment (GAD-7)(At baseline (week 1) and end of treatment (week 8))
- Craving Thermometer VAS(up to 6 weeks)
- The Treatment Outcome Profile (TOP)(At baseline (week 1) and end of treatment (week 8))
- Dual EEG resting-state Frontal Midline Theta(At week 3 and week 6)