Substance Use Disorders Clinical Trial
— CRAVEMTOfficial title:
Feasibility of Music Therapy, Neural Processing and Reduction of Craving in Community Substance Misuse Treatment Services (CSMTS)
Verified date | January 2023 |
Source | Anglia Ruskin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | June 28, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Westminster Drug project | London |
Lead Sponsor | Collaborator |
---|---|
Anglia Ruskin University | Westminster Drug Project |
United Kingdom,
Albornoz, Y. (2011). The effects of group improvisational music therapy on depression in adolescents and adults with substance abuse: a randomized controlled trial. Nordic Journal of Music Therapy, 20, 208-224.
Carter, T.E., Panisch, L.S. A Systematic Review of Music Therapy for Psychosocial Outcomes of Substance Use Clients. *Int J Ment Health Addiction* **19,** 1551-1568 (2021). https://doi.org/10.1007/s11469-020-00246-8
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Eshaghi Farahmand, S. R., Ahadi, H., Kalhornia Golkar, M., & Sedaghat, M. (2020). Comparison of the Effectiveness of Music Therapy and Cognitive Behavioral Therapy on Quality of Life, Craving and Emotion Regulation in Patients Under Methadone Maintenance
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Fachner, J. (2017). Retraining of Drug Reward, Music Cues and State-dependent Recall in Music Therapy. Music and Medicine, 9(1), 8-14.
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Hohmann L, Bradt J, Stegemann T, Koelsch S. Effects of music therapy and music-based interventions in the treatment of substance use disorders: A systematic review. PLoS One. 2017 Nov 15;12(11):e0187363. doi: 10.1371/journal.pone.0187363. eCollection 2017 — View Citation
Huang Y, Mohan A, De Ridder D, Sunaert S, Vanneste S. The neural correlates of the unified percept of alcohol-related craving: a fMRI and EEG study. Sci Rep. 2018 Jan 17;8(1):923. doi: 10.1038/s41598-017-18471-y. — View Citation
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Ridder HM and Fachner J. (2016) Objectivist case study research. Single-subject and small-n research. In: Wheeler B and Murphy K (eds) Music Therapy Research. 3 ed. Dallas: Barcelona Publishers, 291-302.
Silverman, M. J. (2019). Effects of group-based educational songwriting on craving in patients on a detoxification unit: A cluster-randomized effectiveness study. Psychology of Music, 47(2), 241-254.
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retention in Treatment 1 (Attendance Sheet) | 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. | up to 6 weeks | |
Primary | Acceptability of Treatment 1 (Participant Satisfaction Survey) | 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). |
Post-Intervention Measure: at week 8 | |
Primary | Acceptability of treatment 2 (Focus Groups) | 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. |
Post-Intervention Measure: at week 9 | |
Primary | Retention in Treatment 2 (Treatment Status) | 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 | 1-month post-intervention: at week 11 | |
Secondary | The Brief Substance Craving Scale (BSCS) | The Brief Substance Craving Scale (BSCS) is a multi-item subjective measure to assess changes in craving symptoms experienced over a 24-h period. It ranges from 0-12, with 12 indicating the highest level of craving. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | Craving Thermometer VAS | The craving thermometer is a visual analogue scale (VAS) type of measure that allows a quick one-click estimate of the instantaneous subjective feeling of craving (from 0-100). Participants will be asked to indicate their level of craving by responding to the question: "Please, rate how strong your drug craving is right now by putting a mark on the line going from not craving at all to the most ever". Participants will simply read the question and evaluate their subjective feeling of instantaneous craving by putting a mark at any level on the horizontal line. Then, responses will be recorded as a 0 to 10 score (including decimal numbers). The Craving Thermometer will be administered before and after each MT session. | up to 6 weeks | |
Secondary | The Treatment Outcome Profile (TOP) | The Treatment Outcome Profile (TOP) is a multi-item subjective measure to assess changes in substance use, days of primary substance used, usage of primary substance per day, physical wellbeing, mental wellbeing and overall quality of life compared to a baseline measurement. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | The Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ-9) is a multi-item questionnaire to assess changes in depressive symptoms. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | The Generalised Anxiety Disorder Assessment (GAD-7) | The Generalised Anxiety Disorder Assessment (GAD-7) is a multi-item subjective measure to assess changes in anxiety symptoms. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | Resting-state EEG frontal alpha asymmetry (FAA) | Resting-state EEG frontal alpha asymmetry (FAA) will be a measure to evaluate the neural correlates of depressive symptoms. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | Resting-state EEG frontal midline theta (FMT) | Resting-state EEG frontal midline theta (FMT) will be a measure to evaluate the neural correlates of anxiety symptoms. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | Resting-state EEG beta frequency band | Resting-state EEG variation of the beta frequency band will be a measure to evaluate the neural correlates of craving. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | Go/No-Go Event-Related Potentials (ERPs) task | A behavioural measure (accuracy) during a Go/No-Go task and EEG ERP P3 amplitude will be collected to assess inhibitory control in participants allocated to IMT, GMT and ST. | At baseline (week 1) and end of treatment (week 8) | |
Secondary | EEG Hyperscanning | In the IMT arm of the study Dual-EEG (EEG hyperscanning) will be measured from the therapist and from the participant to test the feasibility of using the hyperscanning to study the mechanism of change and potentially to collect data on the time course of emotional processing and therapeutic relationship. The EEG hyperscanning data will be collected throughout the music therapy sessions 2 and 5. | At week 3 and week 6 | |
Secondary | Dual EEG resting-state Frontal Alpha Asymmetry | In the IMT arm of the study 5-minutes of Dual EEG resting-state data from therapist and patient before the beginning and at the end of therapy session 2 and 5 will be recorded. This will allow to assess pre-post session changes in the neural correlates of depressive symptoms with Frontal Alpha Asymmetry. |
At week 3 and week 6 | |
Secondary | Dual EEG resting-state Frontal Midline Theta | In the IMT arm of the study 5-minutes of Dual EEG resting-state data from therapist and patient before the beginning and at the end of therapy session 2 and 5 will be recorded. This will allow to assess pre-post session changes in the neural correlates of anxiety symptoms with Frontal Midline Theta. |
At week 3 and week 6 | |
Secondary | Dual EEG resting-state Beta waves | In the IMT arm of the study 5-minutes of Dual EEG resting-state data from therapist and patient before the beginning and at the end of therapy session 2 and 5 will be recorded. This will allow to assess pre-post session changes in the neural correlates of craving symptoms with beta waves. |
At week 3 and week 6 | |
Secondary | Semi-structured interview | After session 2 and session 5 in the IMT arm of the study a semi-structured interview will be conducted to explore moments of therapeutic interest. These moments will be selected by importance and emotional relevance. Participants may also report verbally any craving related experience. Moments of interest will be identified and located in the recording session. These reports and their timestamp of occurrence will be entered into a therapy event log. The interview will potentially help to select and identify therapeutically important moments: defined as moments of interest (MOI). This is important to describe a narrative of the therapeutic change process and to analyse EEG event-related temporal dynamics during MOI as compared to moments of non-interest (MONI). This semi-structured interview will also be conducted to explore participants' perspective and experience of using music technology in a music therapy intervention. |
At week 3 and week 6 | |
Secondary | Helping Alliance Questionnaire - II (HAQ-II) | The Helping Alliance Questionnaire - II (HAQ-II) will be completed by both the therapist and the client. The HAQ-II is a 19 item questionnaire measuring the quality of the therapist-patients relationship on a scale ranging from 1-6, with 6 indicating the highest helping alliance rating. | At week 3 and week 6 |
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