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

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

      • Shanghai, China
        • Shanghai Women's Compulsory Isolation Detoxification Center

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.
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.
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.

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

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)
Baseline, 2 months,4 months, and 7months
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)
Baseline, 2 months,4 months, and 7months
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
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)
Baseline, 2 months,4 months, and 7months
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
Baseline, 2 months,4 months, and 7months
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.

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

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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