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The Application of Music Therapy in Female Amphetamine Use Disorder

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ClinicalTrials.gov Identifier: NCT03221283
Recruitment Status : Completed
First Posted : July 18, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Min ZHAO, Shanghai Mental Health Center

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 Not Applicable

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  (Clinical Trial)
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 : November 30, 2017
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221283


Locations
China
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

Responsible Party: Min ZHAO, Vice President, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03221283     History of Changes
Other Study ID Numbers: MZhao-007
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Min ZHAO, Shanghai Mental Health Center:
Music therapy
Depression
Emotion
Motivation

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors