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The Application of Music Therapy in Female Amphetamine Use Disorder

Primary Purpose

Amphetamine Addiction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Music therapy group
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine Addiction focused on measuring Music therapy, Depression, Emotion, Motivation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Women's Compulsory Isolation Detoxification Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

Music therapy group

Arm Description

Participants only accept the regular scheduled in the compulsory isolated detoxification center.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Depression status assessed by Self-rating Depression Scale (SDS) at 4 months.
evaluate all participants' depression status by Self-rating Depression Scale (SDS)

Secondary Outcome Measures

Anxiety status assessed by Self-rating Anxiety Scale (SAS)
evaluate all participants' anxiety status by Self-rating Anxiety Scale (SAS)
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS)
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
Empathy ability assessed by Interpersonal Reactivity Index-C(IRI-C)
evaluate all participants' Empathy ability by Interpersonal Reactivity Index-C(IRI-C)
Motivation for treatment assessed by Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
evaluate all participants' motivation for treatment assessed by Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
Change from Baseline emotional status assessed by emotional STROOP paradigm
evaluate all participants' emotional status by emotional STROOP paradigm
Sleep status assessed by Pittsburgh Sleep Quality Index(PSQI)
evaluate all participants' sleep status by Pittsburgh Sleep Quality Index(PSQI)

Full Information

First Posted
July 15, 2017
Last Updated
November 18, 2018
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03221283
Brief Title
The Application of Music Therapy in Female Amphetamine Use Disorder
Official Title
The Intervention of Group Therapy: Music in Mood Problems of Female Amphetamine Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The group music therapy will be used to treat female amphetamine-type stimulant (ATS) addiction
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Addiction
Keywords
Music therapy, Depression, Emotion, Motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants only accept the regular scheduled in the compulsory isolated detoxification center.
Arm Title
Music therapy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music therapy group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Depression status assessed by Self-rating Depression Scale (SDS) at 4 months.
Description
evaluate all participants' depression status by Self-rating Depression Scale (SDS)
Time Frame
Baseline, 2 months,4 months, and 7months
Secondary Outcome Measure Information:
Title
Anxiety status assessed by Self-rating Anxiety Scale (SAS)
Description
evaluate all participants' anxiety status by Self-rating Anxiety Scale (SAS)
Time Frame
Baseline, 2 months,4 months, and 7months
Title
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS)
Description
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
Time Frame
Baseline, 2 months,4 months, and 7months
Title
Empathy ability assessed by Interpersonal Reactivity Index-C(IRI-C)
Description
evaluate all participants' Empathy ability by Interpersonal Reactivity Index-C(IRI-C)
Time Frame
Baseline, 2 months,4 months, and 7months
Title
Motivation for treatment assessed by Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
Description
evaluate all participants' motivation for treatment assessed by Stages of Change Readiness and Treatment Eagerness Scale(SOCRATES)
Time Frame
Baseline, 2 months,4 months, and 7months
Title
Change from Baseline emotional status assessed by emotional STROOP paradigm
Description
evaluate all participants' emotional status by emotional STROOP paradigm
Time Frame
Baseline, 2 months,4 months, and 7months
Title
Sleep status assessed by Pittsburgh Sleep Quality Index(PSQI)
Description
evaluate all participants' sleep status by Pittsburgh Sleep Quality Index(PSQI)
Time Frame
Baseline, 2 months,4 months, and 7months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao min, PhD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Women's Compulsory Isolation Detoxification Center
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Application of Music Therapy in Female Amphetamine Use Disorder

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