Amphetamine AddictionNCT03221283
The Application of Music Therapy in Female Amphetamine Use Disorder
A study testing Music therapy group in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The group music therapy will be used to treat female amphetamine-type stimulant (ATS) addiction Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Amphetamine Addiction
- What is being tested?
- Music therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other substance abuse or dependence in recent a years (except nicotine)
- Mental impairment, Intelligence Quotient (IQ) < 70
- Mental disorders
- Physical disease
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Women's Compulsory Isolation Detoxification Center
Shanghai
About this study
Official title: 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
Read the 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.
- Conditions
- Amphetamine Addiction
- Being tested
- Music therapy group
- Keywords
- Music therapy, Depression, Emotion, Motivation
- Medical subject headings
- Amphetamine-Related Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 2 months,4 months, and 7months
Secondary outcomes (6)
Anxiety status assessed by Self-rating Anxiety Scale (SAS)
evaluate all participants' anxiety status by Self-rating Anxiety Scale (SAS)
Measured: Baseline, 2 months,4 months, and 7months
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS)
evaluate all participants' craving for ATS by Visual Analog Scales (VAS)
Measured: Baseline, 2 months,4 months, and 7months
Empathy ability assessed by Interpersonal Reactivity Index-C(IRI-C)
evaluate all participants' Empathy ability by Interpersonal Reactivity Index-C(IRI-C)
Measured: Baseline, 2 months,4 months, and 7months
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)
Measured: Baseline, 2 months,4 months, and 7months
Change from Baseline emotional status assessed by emotional STROOP paradigm
evaluate all participants' emotional status by emotional STROOP paradigm
Measured: Baseline, 2 months,4 months, and 7months
Sleep status assessed by Pittsburgh Sleep Quality Index(PSQI)
evaluate all participants' sleep status by Pittsburgh Sleep Quality Index(PSQI)
Measured: Baseline, 2 months,4 months, and 7months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start30 Nov 2017
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine AddictionStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min ZHAO, Shanghai Mental Health Center
- Investigators
- Zhao min, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221283
- Sponsor's protocol ID
- MZhao-007
- Status last verified
- Nov 2018
- First submitted
- 15 Jul 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intervention of Group Therapy: Music in Mood Problems of Female Amphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT03221283
- Acronym / sponsor ID
- MZhao-007
- Conditions
- Amphetamine Addiction
- Keywords
- Music therapy, Depression, Emotion, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Participants only accept the regular scheduled in the compulsory isolated detoxification center. |
| Music therapy group | Experimental | Behavioral: Music therapy groupUse 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Other substance abuse or dependence in recent a years (except nicotine)
- Mental impairment, Intelligence Quotient (IQ) < 70
- Mental disorders
- Physical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy groupThe 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. | Behavioural | Music therapy group |
Primary outcome
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)
6 secondary outcomes
Anxiety status assessed by Self-rating Anxiety Scale (SAS)
Time frame: 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
Empathy ability assessed by Interpersonal Reactivity Index-C(IRI-C)
Time frame: 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
Change from Baseline emotional status assessed by emotional STROOP paradigm
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao min, PhD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy group in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Depression status assessed by Self-rating Depression Scale (SDS) at 4 months. (time frame: Baseline, 2 months,4 months, and 7months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.