NCT03221283

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

July 15, 2017

Last Update Submit

November 18, 2018

Conditions

Keywords

Music therapyDepressionEmotionMotivation

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline, 2 months,4 months, and 7months

Secondary Outcomes (6)

  • Anxiety status assessed 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)

    Baseline, 2 months,4 months, and 7months

  • Empathy ability assessed 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)

    Baseline, 2 months,4 months, and 7months

  • Change from Baseline emotional status assessed by emotional STROOP paradigm

    Baseline, 2 months,4 months, and 7months

  • +1 more secondary outcomes

Study Arms (2)

control group

NO INTERVENTION

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

Music therapy group

EXPERIMENTAL

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

Interventions

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.

Music therapy group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Other substance abuse or dependence in recent a years (except nicotine)
  • Mental impairment, Intelligence Quotient (IQ) \< 70
  • Mental disorders
  • Physical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Women's Compulsory Isolation Detoxification Center

Shanghai, China

Location

MeSH Terms

Conditions

Amphetamine-Related DisordersDepression

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Zhao min, PhD

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

July 15, 2017

First Posted

July 18, 2017

Study Start

November 30, 2017

Primary Completion

August 30, 2018

Study Completion

September 30, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations