The Application of Music Therapy in Female Amphetamine Use Disorder

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Completed

CT.gov ID

NCT03221283

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amphetamine Addiction	Behavioral: Music therapy group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Intervention of Group Therapy: Music in Mood Problems of Female Amphetamine Use Disorder

Actual Study Start Date :

Nov 30, 2017

Actual Primary Completion Date :

Aug 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

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.	Behavioral: Music therapy group 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.

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.

Behavioral: Music therapy group

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline Depression status assessed by Self-rating Depression Scale (SDS) at 4 months. [Baseline, 2 months,4 months, and 7months]
evaluate all participants' depression status by Self-rating Depression Scale (SDS)

Secondary Outcome Measures

Anxiety status assessed by Self-rating Anxiety Scale (SAS) [Baseline, 2 months,4 months, and 7months]
evaluate all participants' anxiety status by Self-rating Anxiety Scale (SAS)
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) [Baseline, 2 months,4 months, and 7months]
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
Empathy ability assessed by Interpersonal Reactivity Index-C(IRI-C) [Baseline, 2 months,4 months, and 7months]
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) [Baseline, 2 months,4 months, and 7months]
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 [Baseline, 2 months,4 months, and 7months]
evaluate all participants' emotional status by emotional STROOP paradigm
Sleep status assessed by Pittsburgh Sleep Quality Index(PSQI) [Baseline, 2 months,4 months, and 7months]
evaluate all participants' sleep status by Pittsburgh Sleep Quality Index(PSQI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Women's Compulsory Isolation Detoxification Center	Shanghai		China

Sponsors and Collaborators

Shanghai Mental Health Center

Investigators

Principal Investigator: Zhao min, PhD, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Min ZHAO, Vice President, Shanghai Mental Health Center

ClinicalTrials.gov Identifier:

NCT03221283

Other Study ID Numbers:

MZhao-007

First Posted:

Jul 18, 2017

Last Update Posted:

Nov 20, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Min ZHAO, Vice President, Shanghai Mental Health Center

Additional relevant MeSH terms:

Amphetamine-Related Disorders

Study Results

No Results Posted as of Nov 20, 2018