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临床试验/NCT07279246
NCT07279246已完成不适用

The Effects of Exercise and Music Combination on Drug Cravings, Depression and Self-Efficacy Among Drug Addicts

WEIPENG DUAN1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Self-Efficacy

研究概览

简要总结

This study focuses on the rehabilitation of drug addicts by combining exercise and music, to find out whether exercise and exercise combined with music of different rhythms will have an improvement for drug addicts.

  1. What are the Chinese translated versions of the Basic Depression Questionnaire (CBD), the Mann Craving Scale (MaCS), the Quick Inventory of Depressive Symptoms (QIDS SR-16), and the New General Self-Efficacy Scale (NGSES)?
  2. Based on confirmatory factor analysis, are the Chinese versions of the CBD, MaCS, QIDS SR-16, and NGSES valid and reliable?
  3. Is the concurrent validity of the translated versions of the CBD and MaCS supported when compared to the Chinese versions of the Quick Inventory of Depressive Symptoms (QIDS SR-16) and the Visual Analogue Scale (VAS), respectively?
  4. Which exercise programs, fast-paced music, and slow-paced music are suitable for drug addicts?
  5. is there an effect of exercise and music therapy on drug craving, depression, and self-efficacy in drug addicts (time, group, and interaction)? The researchers divided the participants into four groups: a control group; an exercise group; an exercise combined with a tempo group; and an exercise combined with a slow tempo group.
  • Scientific physical activity at a fixed time each week for 6 months
  • Conducted questionnaires and addiction level tests between each month
  • Record their emotional status and addiction level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Drug-addicted individuals aged 18 years or older.
  • Confirmed diagnosis of drug addiction through testing and currently undergoing compulsory drug rehabilitation treatment at a compulsory isolation drug rehabilitation centre in China.
  • Educational attainment of primary school level or above and capable of independently completing questionnaires.
  • No prior occupational experience in sports or music-related fields.

排除标准

  • Less than six months remaining in the educational phase of compulsory isolation drug rehabilitation.
  • Presence of other severe drug addiction-related complications, such as infectious diseases (e.g., HIV/AIDS), severe cardiovascular or respiratory system diseases.
  • Presence of other conditions that may impair hearing or motor function, such as hearing impairments or medical contraindications for physical activity due to other health conditions.
  • Refusal to participate in this experimental study or refusal to sign the informed consent form.

结局指标

主要结局

Self-Efficacy

时间窗: Measurements were taken from the commencement of the experiment until its conclusion, with one measurement prior to the experiment and one monthly thereafter, totalling seven measurements over the six-month experimental period.

Self-efficacy will be evaluated using the New General Self-Efficacy Scale (NGSES). The NGSES is a Likert-type scale with a total scores range from 8 to 40, with higher scores indicating greater perceived self-efficacy.

Depression

时间窗: Indicator measurements were taken from the commencement of the experiment until its conclusion, with one measurement taken prior to the experiment and subsequent monthly measurements every month thereafter, totalling seven measurements over the six-month

Depression serves as the single core indicator under investigation, assessed via two independent scales: ① the Common Depression Questionnaire (CBD), and ② the Quick Inventory of Depressive Symptoms (QIDS-SR16). Both scales measure participants' depressive states, yet results will be presented and analysed separately to enhance the reliability and stability of depression symptom assessment. The CBD scores range from 0 to 63 points, with higher scores indicating greater severity of depression. Scores are categorised as follows: no depression (0 to 19); mild depression (20 to 29); moderate depression (30 to 39); and severe depression (40 or more). The QIDS-SR16 ranges from 0-27 points, with higher scores indicating greater depression severity.1-5 points: no depression; 6-10 points: mild depression;11-15 points: moderate depression; 16-20 points: severe depression; 21-27 points: very severe depression.

Drug Craving

时间窗: Indicator measurements were taken from the commencement of the experiment until its conclusion, with one measurement taken prior to the experiment and subsequent monthly measurements every month thereafter, totalling seven measurements over the six-month

This study employed the Mannheim Craving Scale (MaCS) German version and the Visual Analogue Scale (VAS) to assess participants' drug craving levels. Both instruments measure the same core indicator, "drug craving level", but were recorded and analysed as independent measurement tools to enhance measurement reliability and reflect the breadth of the dimension. * MaCS (German version) is a graded rating scale (scoring range: 0-48 points, with higher scores indicating stronger craving) * VAS visual analogue scoring employs a 0-10 cm quantitative scale, where 0 denotes complete absence of craving and 10 denotes extremely strong craving Measurement timepoints: One baseline measurement prior to the experiment, followed by monthly measurements during the experiment, totalling seven measurements over six months.

次要结局

未报告次要终点

研究者

发起方
WEIPENG DUAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

WEIPENG DUAN

Lecturer

Universiti Sains Malaysia

研究点 (1)

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