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临床试验/NCT06924892
NCT06924892已完成不适用

Assessment of Music Experiences in Navigating Depression (AMEND)

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Connor-Davidson Resilience Scale (CD-RISC)

研究概览

简要总结

The study team sought to scientifically investigate strategic subsets of depressed individuals or people prone to or at-risk of depression through music experiences of individual, group, and blended supported contexts. Meetings with the study multi-disciplinary team, included member of the Carnegie Hall Weill Music Institute and University affiliates, where the study team gathered quantitative and qualitative data in individual and group forums, measuring disease process and levels of participation. Through tabulation of participatory options with standardized depression and resilience measurements, the study team studied how live music could alter depressive symptoms over time and/ or change negative influencers of mood, shift quality of life, and lead toward possibly enhanced disease trajectory outcomes.

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
Double (Participant, Care Provider)

盲法说明

Participants were provided options for various music study inclusions

入排标准

年龄范围
8 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants between the ages of 8-70 years with a clinical diagnosis of Major Depressive Disorder (MOD) who met the DSM-5 (2013) criteria for a Major Depressive Episode, and/or who identify themselves, or are identified by family, or referring clinicians as depressed, or are prone to depression
  • Depressive episodes and/or showing symptoms of mild to moderate depression intensity
  • Self-reported satisfactory bilateral hearing
  • English or Spanish language fluency sufficient to complete the interviews and questionnaires

排除标准

  • Axis I diagnosis, aside from MOD, considered the primary diagnosis
  • Bipolar Disorder Type I or II,
  • Axis II diagnosis such as antisocial or borderline.
  • Arrhythmia,
  • Pacemaker
  • Prolapsed vertebral disc, and
  • Recent back or neck injuries.

结局指标

主要结局

Connor-Davidson Resilience Scale (CD-RISC)

时间窗: end of study at 3 months

The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. The 10-item instrument has high internal consistency. Each item consists of a 5-point Likert scale (scored from zero to four). Ranging from 0-40 with higher scores reflecting greater perceived resilience.

Child Depression Inventory

时间窗: end of study at 3 months

The total score range 0 to 54 which is converted to a T-Score, higher score indicates more symptoms.

Connor-Davidson Resilience Scale (CD-RISC)

时间窗: end of study at 3 months

The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. The 10-item instrument has high internal consistency. Each item consists of a 5-point Likert scale (scored from zero to four). Ranging from 0-40 with higher scores reflecting greater perceived resilience.

The Beck Depression Inventory Second Edition (BDI-II) score

时间窗: end of study at 3 months

The Beck Depression Inventory Second Edition (BDI-II) is a multiple-choice self-report inventory that assesses severity of depression. The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.

Child Depression Inventory

时间窗: end of study at 3 months

The total score range 0 to 54 which is converted to a T-Score, higher score indicates more symptoms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Loewy

Professor/Director

Icahn School of Medicine at Mount Sinai

研究点 (2)

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