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临床试验/NCT02925325
NCT02925325Unknown不适用

Music Therapy for Major Depressive Disorder Residual Symptoms

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
2
主要终点
Clinical Interview for Depression and Related Syndromes

研究概览

简要总结

Residual Symptoms of Depression (SRD) are those symptoms that persist despite remission of MDD. They are characterized by a high incidence (approx. 90% of patients in remission) at the psychiatric clinic, have become a growing problem. Its presence is associated with a high probability of relapse / recurrence and disability, as determined by decreased performance and low quality of life. Their neglect has generated an increase in clinical and socioeconomic costs, alerting the need for research to provide treatment strategies. The application of different types of psychotherapy has been successful in abating SRD. The present study aims to evaluate the clinical changes related to the application of music therapy as a treatment of SRD, through a randomized controlled trial with two treatment arms trial. Music Therapy (MT) is a psychotherapy provided by specialized health professionals, and is defined as the clinical use of musical evidence-based interventions within a therapeutic relationship. MT treatment group will design an application schema of 8 sessions (2 hrs. Each) over a period of two months (one session per week). The control group will receive the Usual Treatment (TU) which corresponds to the usual clinical psychiatric treatment by the physician in the INPRF, with the same duration. The evaluation will be conducted with clinimetric testing at baseline, at the end of the track and after three months of treatment. This study seeks to identify the presence of SRD in a Mexican sample and explore a treatment designed for that purpose, also, show that the MT is a cost-effective implementation can become a new clinical option to extend the possibilities of assistance and deepen the investigation of this problem.

详细描述

GENERAL PURPOSE:

To evaluate the clinical changes related to the application of music therapy as a treatment for Residual Symptoms of Depression.

SPECIFIC OBJECTIVES:

  1. Compare the pre and post treatment of residual symptoms by the HAM-D-21, BDI, SCL-90-R and CIDRS levels.
  2. Compare the change of pre and post treatment obtained by the instruments for quality of life (WHOQOL-BREF), functioning (GAF and PSP) and perceived stress (PSS) values.

METHOD

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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subsequent and file number at the National Institute of Psychiatry "Ramon de la Fuente" patients.
  • Male or Female Patients.
  • Age 20-45 years.
  • Previous diagnosis of MDD according to DSM-IV.
  • Presence of residual symptoms, with a score of ≤7 points in the HAM-D-21 and / or ≤9 points in BDI.
  • Patients who agree to sign informed consent sheet.
  • Patients without a psychotherapeutic treatment during the 8 weeks prior to baseline.
  • Patients with any pharmacological antidepressant treatment in continuation phase or maintenance (Eg. SSRIs, benzodiazepines) with good adherence.

排除标准

  • Patients with psychotic symptoms.
  • Patients with suicidal risk.
  • Patients with comorbid Axis I.
  • Patients with comorbid Axis II as the primary diagnosis.
  • Patients with any type of hearing chronic medical illness, neurological or (Eg. Hearing loss, tinnitus, etc.)
  • Patients with addiction to any substance (except caffeine and nicotine).
  • Patients with medical or psychological problems related to music (Eg. Amusia or musicogenic Epilepsy.
  • Pregnant women.

结局指标

主要结局

Clinical Interview for Depression and Related Syndromes

时间窗: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up

Hamilton Depression Rating Scale

时间窗: 3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up

次要结局

  • Symptom Checklist 90 Revised (SCL-90-R)(3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up)
  • Perceived stress scale (PSS)(3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up)
  • WHO Quality of Life-BREF (WHOQOL-BREF)(3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up)
  • Personal and social performance scale (PSP)(3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up)
  • Beck Depression Inventory(3 times: Baseline, Change from Baseline at the end of 2 Months Music Therapy and change from baseline at 3 months follow up)

研究者

发起方
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge J. González Olvera

Dr.

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

研究点 (2)

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