- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221283
The Application of Music Therapy in Female Amphetamine Use Disorder
November 18, 2018 updated by: Min ZHAO, Shanghai Mental Health Center
The Intervention of Group Therapy: Music in Mood Problems of Female Amphetamine Use Disorder
The group music therapy will be used to treat female amphetamine-type stimulant (ATS) addiction
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Amphetamine addicts are often accompanied by severe emotional problems and are difficult to control and regulate negative emotions by themselves.And the emotional problems are high risk factors of addicts relapse.
Music therapy as the intervention is in order to improve amphetamine addicts' emotional status and the ability of emotion regulation.
Self-rating Depression Scale(SDS), Self-rating Anxiety scale(SAS) will be used to investigate the emotion of participants.
These methods will also be used to evaluate the efficacy of the intervention.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Shanghai, China
- Shanghai Women's Compulsory Isolation Detoxification Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorder
- Junior high school degree or above
- Normal vision and hearing
- Have emotional problem
Exclusion Criteria:
- Other substance abuse or dependence in recent a years (except nicotine)
- Mental impairment, Intelligence Quotient (IQ) < 70
- Mental disorders
- Physical disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Participants only accept the regular scheduled in the compulsory isolated detoxification center.
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|
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Experimental: Music therapy group
Use randomized controlled clinical trial design.The main content of music therapy is emotional experience , emotion regulation, emotional control and emotional expression.
The experimental group received 13 group music sessions over a three-month period.
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The experimental group received 13 group music sessions over a three-month period.
Different method of music therapy will be used to improve the emotion experience, emotion regulation, emotional control and emotional expression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Depression status assessed by Self-rating Depression Scale (SDS) at 4 months.
Time Frame: Baseline, 2 months,4 months, and 7months
|
evaluate all participants' depression status by Self-rating Depression Scale (SDS)
|
Baseline, 2 months,4 months, and 7months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety status assessed by Self-rating Anxiety Scale (SAS)
Time Frame: Baseline, 2 months,4 months, and 7months
|
evaluate all participants' anxiety status by Self-rating Anxiety Scale (SAS)
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Baseline, 2 months,4 months, and 7months
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Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS)
Time Frame: Baseline, 2 months,4 months, and 7months
|
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
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Baseline, 2 months,4 months, and 7months
|
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Empathy ability assessed by Interpersonal Reactivity Index-C(IRI-C)
Time Frame: Baseline, 2 months,4 months, and 7months
|
evaluate all participants' Empathy ability by Interpersonal Reactivity Index-C(IRI-C)
|
Baseline, 2 months,4 months, and 7months
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Motivation for treatment assessed by Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
Time Frame: Baseline, 2 months,4 months, and 7months
|
evaluate all participants' motivation for treatment assessed by Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
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Baseline, 2 months,4 months, and 7months
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Change from Baseline emotional status assessed by emotional STROOP paradigm
Time Frame: Baseline, 2 months,4 months, and 7months
|
evaluate all participants' emotional status by emotional STROOP paradigm
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Baseline, 2 months,4 months, and 7months
|
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Sleep status assessed by Pittsburgh Sleep Quality Index(PSQI)
Time Frame: Baseline, 2 months,4 months, and 7months
|
evaluate all participants' sleep status by Pittsburgh Sleep Quality Index(PSQI)
|
Baseline, 2 months,4 months, and 7months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2017
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
July 15, 2017
First Submitted That Met QC Criteria
July 15, 2017
First Posted (Actual)
July 18, 2017
Study Record Updates
Last Update Posted (Actual)
November 20, 2018
Last Update Submitted That Met QC Criteria
November 18, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MZhao-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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